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The Innovasive Devices 8mm Ligament Fastener is intended for ligament to bone reattachment of Anterior and Posterior Cruciate Ligaments in patients with recurrent instability of the knee.

The Innovasive 8mm Ligament Fastener is an implantable tendon fixation device complete with the instrumentation needed to effect ligament to bone repair. The devices consist of a high density polyethylene sleeve with an acetal drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a hex driver, for screwing in the sleeve, and an inserter which drives the pin into the sleeve.

In addition to the Fastener, a stainless steel drill is available to establish the proper hole in the bone for the Fastener. All of the instrumentation except the Fastener will be offered as reusable devices and be autoclaved in the sterilization tray provided for this purpose.

The Fastener will be available as a sterile, single use device for use in both an open and arthroscopic procedures.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that demonstrates the device meets these criteria:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The text mentions a "Cadaver study," implying human cadaveric tissue was used. However, the exact sample size (number of cadavers or individual tests) and the country of origin are not specified. It is a retrospective study in the sense that it uses pre-existing biological material (cadavers) rather than living patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for holding strength appears to be derived from direct physical measurements in the cadaver study, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as expert consensus or interpretation was not the primary means of establishing ground truth for holding strength. The outcome was a direct measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with and without AI assistance. This device is a physical implant, and its performance is measured mechanically.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone study was done in the sense that the device's mechanical performance (holding strength) was directly measured without continuous human intervention during the measurement process, beyond setting up the experiment. There is no "algorithm" in the context of this mechanical device.

7. Type of Ground Truth Used

The type of ground truth used was direct mechanical measurement of ultimate holding strength in cadaveric bone. This is a form of empirical or objective data rather than expert consensus, pathology, or outcomes data in the usual medical imaging or diagnostic sense.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning algorithm. The "study" described is a direct comparative mechanical test, not an AI-driven system requiring training data.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned, the question of how its ground truth was established is not applicable.

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