(196 days)
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.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.