(126 days)
The OCT (Osteochondral Transplant) Comprehensive System is indicated for arthroscopic (Knee and Ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.
The OCT (Osteochondral Transplant) Comprehensive System is a kit composed of several orthopedic surgical instruments. These instruments include Drill Sleeve Cap, Drills, Toothed Core Sleeve and Plunger, Obturators, Sizers, Drill Handle, Ruler and Drill Sleeves and Sterilization Tray. All instruments are composed of stainless steel and/or injection molded plastic. The instruments range in size from 3 to 11 mm.
This appears to be a 510(k) premarket notification for a medical device (OCT Comprehensive System) and not a study describing the device's performance against acceptance criteria. There is no information in the provided text about acceptance criteria or a study proving the device meets them.
The document is a communication from the FDA to OsteoBiologics, Inc., confirming that their device, the OCT (Osteochondral Transplant) Comprehensive System, is substantially equivalent to a previously cleared predicate device (Acufex "MosaicPlasty" Comprehensive System, K964215). This "substantial equivalence" determination is the basis for its clearance, not a performance study against specific acceptance criteria.
Therefore, I cannot provide the requested information because it is not present in the provided text.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.