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The intended use of the Meniscal Dart is intended for use in the arthroscopic fixation of longitudinal, vertical meniscus lesions (bucket handle lesions) in the vascularized area of the meniscus (red-red and red-white areas).

The Meniscal Dart is a device fabricated from L-PLA which is intended for meniscal repair. The device consists of a molded device with a back tab and barbs along its length. The device is inserted into the meniscus with the aid of an inserter instrument. Additional instruments include calibration instruments to measure the depth of the tear. The Meniscal Dart is provided in 3 sizes, 10, 11 and 13mm.

The provided document describes the Innovasive Meniscal Dart, a bioabsorbable orthopedic fixation device. The 510(k) summary focuses on establishing substantial equivalence to a predicate device, the Biofix Arrow, rather than presenting a performance study with defined acceptance criteria and specific outcomes like sensitivity, specificity, or accuracy.

Therefore, many of the requested categories (e.g., specific acceptance criteria, sample sizes for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not available in the provided text, as these are typically part of a comprehensive performance study. The document primarily reports on bench and animal testing comparing the device to a predicate.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

Study that Proves Device Meets Acceptance Criteria:

The document refers to two types of testing:

1. Bench Testing: This involved in vitro comparison of the Meniscal Dart's fatigue strength against a predicate device (Biofix Arrow). It also assessed the device's performance under constant load, weight loss, and intrinsic viscosity. The implicit acceptance criterion for fatigue strength would be non-inferiority or equivalence to the predicate device. For the other parameters, the "assessment" implies that the results were within acceptable ranges, though specific numerical criteria are not provided.
2. Animal Testing: This testing aimed to demonstrate the efficacy and confirm the adequate function of the Innovasive Meniscal Dart for its intended use. The implicit acceptance criteria here would be the successful repair of meniscal tears in an animal model, demonstrating the device's ability to hold the repair and that it functions as intended without adverse events that would preclude its use.

Detailed Information Not Available in the Provided Text:

• Sample sizes used for the test set and the data provenance: Not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was not a human observer study.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study was not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used:
  • Bench Testing: Engineering measurements and comparisons to a predicate device's measured performance.
  • Animal Testing: Histopathological and gross pathological examinations, clinical observations of repair success in an animal model.
• The sample size for the training set: Not applicable, as this is not an AI/algorithm.
• How the ground truth for the training set was established: Not applicable.

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