OsteoProbe (OP-100)

The OsteoProbe (OP-100) is a bone microindentation measurement device that assesses bone tissue resistance on the tibia of adults, producing a Bone Material Strength Index (BMSi) score. Laboratory studies show BMSi correlates with biomechanical bone properties like whole-bone strength and fracture toughness, though clinical significance remains unknown. The device is prescription-only and is not intended to diagnose disease, predict fracture risk, or treat any clinical condition.

The device consists of a single-use disposable sterile component (critical Spaulding classification) and reusable non-critical components requiring cleaning and intermediate-level disinfection between uses. It includes one accessory: a single-use disposable sterile cover. The subject device and predicate have identical technological characteristics, materials, packaging, and sterilization methods.

ASTM standards were used for biomechanical testing, including whole-bone strength testing via 3-point bending and fracture toughness testing. Testing was conducted on cadaveric specimens including 67 tibia, 67 femur, 54 radii, and 53 L4 vertebrae, with 18 machined beams per tibia for fracture toughness and 66 beams per femur for tissue-level testing.

The subject device is substantially equivalent to the predicate OsteoProbe [K221195] because they have identical technological characteristics, materials, packaging, and sterilization methods with no differences other than the proposed indication for use. Performance testing demonstrated the device maintains statistically significant correlations with bone strength at multiple anatomical sites and strongly correlates with fracture toughness and key mechanical properties, establishing equivalent safety and effectiveness to the predicate device.