(89 days)
The Arthrotek® Meniscal Hybrid Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
The Arthrotek® Meniscal Hybrid Device incorporates two toggle anchors attached by two suture loops, one suture loop containing a sliding knot. The toggle anchors are approximately 7mm long and have beveled tips on each end. Incorporated into the body of the toggle anchor is an eyelet for the suture to pass through. They are constructed of Lactosorby, a bio-resorbable copolyment of PLLA/PGA
The provided document describes a 510(k) premarket notification for the Arthrotek® Meniscal Hybrid Device, which is a meniscal repair device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Sponsor/FDA) | Reported Device Performance |
|---|---|
| Premarket Requirement: Substantial Equivalence to Predicate Device (K982095) | Demonstrated substantial equivalence in pullout strength to predicate Meniscal Repair Device (K982095). |
| Specific Performance Metric: Pullout Strength | Equivalent pullout strength. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the mechanical testing. The document states "Mechanical testing found the Arthrotek® Meniscal Hybrid Device to be substantially equivalent...". This implies testing was performed on a sample of the new device and the predicate device, but the exact number of units tested is not provided.
- Data Provenance: The testing was non-clinical (mechanical), so geographic origin of patient data is not applicable. It was a controlled laboratory study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This was a non-clinical mechanical test. Ground truth would have been established by engineering and materials science standards for measuring pullout strength, not by clinical expert consensus.
4. Adjudication Method for the Test Set
- Not applicable. As a mechanical test, the results are quantitative measurements, not subjective evaluations requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-powered diagnostic or assistive device. It is a medical device for surgical repair.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-powered algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical testing was quantitative mechanical measurement of pullout strength, established through validated engineering test methods and equipment. This would have involved measuring the force required to pull the device out of a simulated tissue or testing medium.
8. The Sample Size for the Training Set
- Not applicable. There was no "training set" in the context of an algorithm or AI. This was a physical medical device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there was no AI training set.
Summary of the Study and Acceptance Criteria:
The study proving the device meets its acceptance criteria was a non-clinical mechanical testing study. The primary acceptance criterion was demonstrating substantial equivalence in pullout strength to the predicate device (K982095). The study found the Arthrotek® Meniscal Hybrid Device to be "substantially equivalent in pullout strength, to the predicate Meniscal Repair Device." No clinical testing was required or performed for this specific 510(k) submission, as substantial equivalence was established through non-clinical means.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.