(94 days)
The Arthrotek® Maxfire™ Meniscal Repair 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® Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of 2-0 Maxbraid™ ultra-high molecular weight polyethylene/polypropylene suture (Teleflex Medical, K040472) covered with two nonresorbable polyester or polyethylene sleeves. The anchors are pre-loaded on to an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. A pusher within the handle of the inserter allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the free ends of suture are gently pulled by the surgeon, drawing the loops into a flat, donut-shaped ring. This anchor sits on the backside of the meniscus. The suture is covered with either a polyester or polyethylene sleeve in order to control the size of the knot thus ensuring that the anchor does not become too small and pull through the meniscal tissue. By tensioning the suture, a sliding knot allows the meniscal tear to be compressed.
This document is a 510(k) summary for the Arthrotek® Maxfire™ Meniscal Repair Device. It details the device's description, intended use, and claims of substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional within intended use | "The results indicated that the device was functional within its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence." However, it does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the non-clinical data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The testing was non-clinical laboratory testing, not human-read clinical studies.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The testing was non-clinical laboratory testing, not human-read clinical studies requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done. The document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence."
6. Standalone Performance Study:
A standalone study was done in the sense that non-clinical laboratory testing was performed on the device itself. However, this was not an "algorithm only without human-in-the loop performance" study as the device is a physical medical device, not an AI algorithm. The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
7. Type of Ground Truth Used:
The ground truth for the non-clinical testing would have been established through a set of predefined performance specifications and engineering standards for medical devices of this type (suture anchors). The results of the non-clinical laboratory tests would then be compared against these established functional and performance requirements to determine if the device was "functional within its intended use."
8. Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device and therefore does not have a "training set" in the context of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as the device is a physical medical device and does not utilize a training set.
§ 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.