Search Results

a) Carpal tunnel release / carpal tunnel syndrome
b) plantar fasciotomy/ Plantar fascitis
c) lateral release of the knee / extensor mechanism malignment
d) forearm fasciotomy / compartment syndrome
e) Mortons Neuroma/ Interdigital Neuroma

Mountable Endoscopic Knife

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Mountable Endoscopic Knife" (K982142), indicating that the device has been found substantially equivalent to a predicate device.

The letter mentions:

• Trade Name: Mountable Endoscopic Knife
• Regulatory Class: II
• Product Code: EMF
• Indications For Use: Carpal tunnel release/syndrome, plantar fasciotomy/fascitis, lateral release of the knee/extensor mechanism malignment, forearm fasciotomy/compartment syndrome, Mortons Neuroma/Interdigital Neuroma.

However, it does not specify any performance-based acceptance criteria, details of a study (sample size, data provenance, expert involvement, adjudication, MRMC, standalone performance, training set details, or ground truth establishment) used to demonstrate compliance with such criteria. The substantial equivalence determination is based on the device being comparable to a legally marketed predicate device, not necessarily on a performance study against predefined acceptance criteria outlined in this document.

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