(420 days)
The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral condyle) and cancellous fragments (talus).
The Chondral Dart is molded from Poly(L-lactide), has a diameter of 1.3 mm, and is supplied in a length of 18 mm. The device is barbed to facilitate fixation in bone.
This document, a 510(k) Summary for the Arthrex Chondral Dart, does not contain information on acceptance criteria or a study proving that the device meets those criteria.
The 510(k) Summary focuses on demonstrating substantial equivalence to predicate devices already on the market. It compares the material, size, and insertion method of the Arthrex Chondral Dart to several existing absorbable fixation pins.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as a regulatory submission seeking clearance based on similarity to existing devices, rather than a clinical or performance study report.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.