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The IvyAIR Meniscus System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The lvyAIR Meniscus System is indicated for use in meniscal repairs and allograft transplant procedures. The lvyAlR Meniscus System device is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

The IvyAIR Meniscus System is an all-inside meniscus repair device. Each device includes two non-absorbable polymer implants, pre-tied with 2-0 non-absorbable suture and pre-loaded into a needle delivery system. The IvyAIR System is available in three needle configurations: Curved. Straight and Reverse Curve to allow the surgeon a choice for access to the desired zone of the meniscus. The IvyAIR Meniscus System is provided sterile for single use only.

This document describes the IvyAIR Meniscus System, a medical device for meniscal repair. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving performance against specific acceptance criteria for a novel AI device. Therefore, a direct response to some of the requested points ("AI assistance effect size," "sample size for the training set," "how ground truth for the training set was established") is not applicable or not explicitly detailed in the provided text, as the device is a physical surgical suture retention system, not an AI-powered diagnostic or assistive tool.

However, I can extract information related to the performance data and "acceptance criteria" as they pertain to the device's engineering design and biocompatibility testing in comparison to its predicate.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All of the pre-determined acceptance criteria were met with passing results." However, it does not explicitly list the specific numerical acceptance criteria for "Implant strength test to failure" or "Dynamic and static tensile loading." It only lists the tests performed. The acceptance criteria for biocompatibility tests are generally established by regulatory standards (e.g., ISO 10993).

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

The document does not specify the sample size for the bench and biocompatibility tests. The data provenance is implied to be from internal testing conducted by Ivy Sports Medicine, LLC. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission, but the tests themselves are standard laboratory/bench tests, not clinical studies involving patient data.

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

Not applicable. This device is not an AI/diagnostic device that requires expert ground truth for its performance evaluation (e.g., interpreting images). Its performance is evaluated through material science and biological compatibility testing against established standards.

4. Adjudication Method for the Test Set

Not applicable. This concept is typically relevant to clinical trials or AI performance evaluations involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a physical medical device (suture retention system), not an AI-powered system designed to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

For the bench testing (Implant strength, Dynamic and static tensile loading), the "ground truth" is typically defined by engineering specifications and comparative performance data against the predicate device, or industry standards for mechanical properties.

For biocompatibility testing, the "ground truth" is the established biological response as defined by international standards (e.g., ISO 10993 series) and observed biological effects in the conducted studies.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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