(10 days)
The Biomet Sports Medicine™ Maxfire™ MarXmen™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and redwhite zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
The Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of a size 2-0 polyethylene/polypropylene ZipLoop™ construct with two #5 polyester sleeves. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop™ is pulled tight, the sleeves lock against the meniscal tissue, pulling the tear together. The sleeves control the size of the knot ensuring that the anchor does not become too small and pull through the meniscal tissue. The anchors are pre-loaded onto 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. The insertion device is available as an in-line inserter or a pistol-grip inserter, the MaxFire™ MarXmen™ Meniscal Repair Device. This allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the knotted end of the ZipLoop™ construct is gently pulled by the surgeon, allowing the meniscal tear to be compressed. The Maxfire™ anchor sits on the back side of the meniscus.
The medical device referenced is the "MaxFire™ and MaxFire™ MarXmen™ Meniscal Repair Devices".
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fixation Strength | Meets acceptance criteria as set by predicate fixation strength. | Meets acceptance criteria as set by predicate fixation strength. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data. The performance data provided is from non-clinical (mechanical) testing. No information is given about the sample size (number of devices or tests performed) for the fixation strength testing. The provenance of the data is also not stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a mechanical implant, and the assessment is based on physical performance (fixation strength) rather than expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication was required for mechanical testing results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "None provided as a basis for substantial equivalence" under the "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This is not an AI/algorithm-based device. It is a mechanical medical implant.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's main performance characteristic (fixation strength) was based on mechanical test results comparing it to a legally marketed predicate device. The acceptance criteria were derived from the performance of the predicate device (Arthrotek® MaxFire™ Meniscal Repair Device - K061776).
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device. The mechanical properties were evaluated against pre-defined acceptance criteria based on the predicate device's performance.
§ 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.