VELMENI for DENTISTS (V4D)

VELMENI for DENTISTS (V4D) is a computer-assisted detection software that assists dentists in detecting dental caries, fillings, restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years or older. The device provides additional analytical information to support dentist examination but is not intended to replace clinical judgment or complete patient assessment.

The proposed device is technologically identical to its predicate (K240003) in all aspects including device features, incorporated models, software version, indications for use, and patient population. The only difference is the addition of a Predetermined Change Control Plan (PCCP) that allows for retraining of machine learning models for the condition detection modules without requiring new premarket notification, provided predefined performance criteria are met.

Not stated in this summary.

Substantial equivalence is established because the subject device and predicate device share identical intended use, design, functionality, and performance characteristics. The PCCP is not a technological difference but rather an approved post-market change control mechanism that allows model retraining while maintaining safety and effectiveness through predefined validation criteria. Since the device itself remains unchanged from the cleared predicate version, existing clinical test data and MRMC results demonstrating effectiveness remain applicable, and no new questions of safety or effectiveness arise.