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Intended Use:

1. Interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

Specific Indications For Use:

1. Open Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)
2. Arthroscopic ACL Reconstruction

The device is a bioresorbable interference screw used for the anterior cruciate ligament (ACL). The Phusis® Absorbable Interference Screw system is made up of two different diameter screws (7.0mm and 9.0mm) available in two lengths for each diameter. The 7.0mm diameter screws are 20 & 25 mm in length and the 9.0mm screws are 25 & 30 mm in length. The thread profile is that of a non aggressive single lead thread (cancellous-type) with a pitch of approximately 12 to the inch. The thread is progressive in nature. That is, the distal end or tip of the screw is tapered slightly to improve ease of insertion.

The cannulation channel serves two purposes, it allows for the insertion of a guide wirelpin and it provides the driver interface. The cannula channel is not round throughout its length, but rather, it is hex in configuration over most of its length. Only the last millimeter near the tip is round. This provides two specific benefits, maximum hex drive interface and excellent insertion when inserted over the guide pine/wire.

Here's a breakdown of the acceptance criteria and the study used to prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) Pre-market Notification for the Phusis® Absorbable Interference Screw. In this regulatory context, "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices. The performance is assessed by comparing key features, indications for use, and a clinical summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The study described is a retrospective review and analysis of European ACL reconstruction clinical results.

• Sample Size for Test Set: The specific number of patients (n) included in the retrospective review is not explicitly stated in the provided text, only that "variables such as n" were detailed.
• Data Provenance: The data is from European ACL reconstruction clinical results and is retrospective.

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

This document describes a regulatory submission ("510(k)") which typically relies on expert consensus in the medical community and previously established evidence for predicate devices.

• Number of Experts: The document does not specify a number of experts specifically used to establish ground truth for this particular retrospective review.
• Qualifications of Experts: It is implied that the "peer review literature" referenced, and the "appropriate statistical methodologies applied," would have been reviewed and analyzed by individuals with expertise in orthopedic surgery, clinical research, and statistical analysis, likely including medical doctors and biostatisticians. However, specific qualifications are not detailed for the individuals conducting this specific review. The FDA's review process itself involves experts in device evaluation.

4. Adjudication Method for the Test Set

The document describes a "retrospective review and analysis" of existing clinical results. It does not mention a specific adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth within the reviewed data. The analysis likely involved synthesizing and comparing reported outcomes from various clinical studies and publications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

• Was an MRMC study done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The study was a retrospective review of existing clinical data, not a direct comparison of human readers with and without AI assistance.
• Effect Size: Therefore, no effect size for human reader improvement with AI assistance is applicable or reported.

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

• Was a standalone study done? No, this device is a physical surgical implant (an absorbable interference screw). The concept of "standalone performance" without human-in-the-loop applies to AI/ML algorithms that interpret data or images. This is not applicable to the Phusis® Absorbable Interference Screw.

7. The Type of Ground Truth Used

The ground truth for the comparison was established based on:

• Clinical Performance Data: A retrospective review of "European ACL reconstruction clinical results" was undertaken, examining "nine common ACL clinical variables." These variables included symptoms, pivot shift, screw breakage, return to activity, complications, and final outcome.
• Peer Review Literature: The clinical performance of the Phusis screw was contrasted with the Linvatec BioScrew and Acufex metallic interference screw "as reported in the peer review literature." This implies a reliance on published clinical outcomes from these predicate devices as a benchmark for comparison.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device (an interference screw), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the device's design and material selection would stem from foundational research in biomaterials and orthopedic surgery, but not a dataset in the AI sense.

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

• Not Applicable. (See point 8).

In summary: The submission relies on demonstrating substantial equivalence to existing legally marketed devices by comparing design features, intended use, materials (with justification for differences), and clinical performance through a retrospective review of European clinical outcomes and comparison to peer-reviewed literature on predicate devices. It is not an AI/ML device, so concepts like training sets, standalone performance, and MRMC studies are not relevant.

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