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The LactoSorb® Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The LactoSorb® devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue.

This document describes a 510(k) premarket notification for the "LactoSorb® Meniscal Repair Device". The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria that the device meets. Therefore, much of the requested information about device performance, ground truth, and expert evaluation is not explicitly available in the provided text.

Here’s a breakdown of the available information and what cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document does not provide specific quantitative acceptance criteria or detailed results of specific tests (e.g., tensile strength, degradation rates compared to a defined threshold). Instead, it makes a general statement of equivalency for in vitro performance and biocompatibility for in vivo performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not specified for in vitro or in vivo studies. The document only mentions "animal and clinical studies" generally.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. The assessment relies on the FDA's determination of substantial equivalence, which primarily reviews the submission's claims and supporting data, not necessarily an independent expert panel for ground truth generation on a specific test set for this device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not provided.

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:

• This device is a meniscal repair device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not applicable and was not done.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable as this is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the "in vitro testing", the ground truth would likely be established mechanical properties of predicate devices or established engineering standards.
• For the "animal and clinical studies" related to biocompatibility and resorption, the ground truth would be based on histopathological analysis, observation of tissue response, and material degradation analysis, which can be considered a form of scientific/pathological ground truth. Specific details are not given.

8. The sample size for the training set:

• This concept is not applicable in the context of this device and submission. There is no AI model or algorithm being "trained." The "animal and clinical studies" mentioned are for evaluating the material's properties and performance, not for training a model.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set in the context of this device.

Summary of the K982095 Submission:

This 510(k) submission for the LactoSorb® Meniscal Repair Device is a premarket notification where Biomet, Inc. sought to demonstrate that their device is "substantially equivalent" to legally marketed predicate devices. The key evidence presented for substantial equivalence involved:

• In Vitro Testing: Showing that the device performs "as well as" predicate devices in meniscal tissue approximation.
• Bioresorbable and Biocompatible Materials: Leveraging the known properties of polylactic/polyglycolic acid copolymer, which has been used in surgical procedures for years and degrades in vivo by hydrolysis. The biocompatibility was supported by existing "animal and clinical studies" (presumably prior studies on the material itself, or limited studies on this specific device, though not detailed here).

The FDA's review concluded that the device was substantially equivalent, allowing it to be marketed. The documentation does not detail specific "acceptance criteria" in the sense of predefined numerical thresholds for a specific study conducted for this submission, nor does it provide the granular data (sample sizes, expert qualifications, ground truth establishment methods) that would be expected for a detailed performance study as one might see for a diagnostic device or AI algorithm. Instead, it relies on general claims of equivalency and established material properties.

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