HESTIA

HESTIA is a full-field digital mammography (FFDM) system for screening and diagnostic breast imaging on standing or seated patients. It generates mammographic images to detect breast cancer signs such as micro-calcifications or tumors, and is intended for use in the same clinical applications as traditional film/screen systems.

HESTIA has identical indications for use and technical characteristics to its predicate device (Aspire Cristalle) regarding indication, patient population, exposure mode, x-ray focal spot size, target material, target angle, kV range, geometry, and software-controlled functions. Minor differences include an added filter option and lower inherent filtration, different detector sensor material but similar active area and array, and different breast compression system—none creating significant diagnostic differences.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-45, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 62304, ISO 14971. Physical laboratory testing included sensitometric response, spatial resolution, noise analysis, signal-to-noise ratio, dynamic range, repeated exposures, AEC performance, phantom tests (ACR Map and CDMAM), and mean glandular dose.

Although HESTIA and the predicate differ in some design elements (added filter, detector material, compression system), clinical image evaluation by qualified radiologists per FDA guidance demonstrated that HESTIA images are substantially equivalent to predicate images for diagnostic mammography. Non-clinical testing confirmed HESTIA meets design inputs and performance specifications consistent with safety and effectiveness standards. These minor differences do not adversely affect the intended use and do not raise new safety or effectiveness questions.