(59 days)
The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.
The MosaicPlasty Comprehensive System is a kit composed of several orthopedic manual surgical instruments. These instruments include drill guides, drill guide plugs, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressor, drill bit adapters and a sterilizing tray. All instruments are composed of stainless steel. The instruments range in diameter from 2.7 mm to 10 mm.
This 510(k) summary describes a surgical instrument system and, as such, does not contain the information required to answer your request. The provided text focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use for regulatory clearance, rather than presenting clinical study data with acceptance criteria and performance metrics typically associated with algorithms or diagnostic devices.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.