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These devices are indicated for soft tissue reattachment in the following shoulder procedures:

1. Instability repairs in the shoulder (Bankart Procedures)
2. SLAP lesion repair
3. Acromio-clavicular separation repairs
4. Rotator cuff tear repairs
5. Capsular shift or capsulolabral reconstructions
6. Biceps tenodesis
7. Deltoid repairs

Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ are resorbable rivets made of Lactosorb® Copolymer. They are designed with ribbed legs that extend during actuation to hold the rivets in the desired position. The heads incorporate spikes to grip the soft tissue and hold it in place during the healing process.

Here's an analysis of the provided information regarding the acceptance criteria and study for the Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided documents focus on establishing substantial equivalence for a medical device (Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™) to a predicate device (Lactosorb® Pop Rivet). The "acceptance criteria" in this context are not presented as numerical thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) but rather as demonstrable equivalence in materials, manufacturing, indications for use, and mechanical properties.

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

• Sample Size: The document does not specify a distinct "test set" in the context of clinical performance data. The evaluation primarily relied on non-clinical mechanical testing. The sample size for this mechanical testing is not provided in the furnished information.
• Data Provenance: The mechanical testing data would be generated in a laboratory setting, likely in the United States where Biomet Inc. is located. It is not clinical data, so terms like "retrospective" or "prospective" do not apply.

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

• Number of Experts: Not applicable. The "ground truth" for mechanical testing is based on objective measurements of fixation strength, not expert interpretation of clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. As the primary evaluation was via mechanical testing, there was no need for adjudication of human interpretations.

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:

• MRMC Study: No. This is a medical device for orthopedic fixation, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.

7. The type of Ground Truth Used:

• Type of Ground Truth: For the non-clinical testing, the "ground truth" was objective measurements of mechanical fixation strength performed on the devices.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Ground Truth Establishment: Not applicable.

Summary of the Study:

The study proving the device met the acceptance criteria was a non-clinical mechanical testing study. This study compared the fixation strength of the Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ to that of the legally marketed predicate device, Lactosorb® Pop Rivet. The key finding was that the new devices demonstrated equivalent or greater fixation strength compared to the predicate. Based on this, and the use of the same materials and manufacturing processes, it was determined that no clinical testing was necessary to establish substantial equivalence with the predicate device.

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