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The SnapShot Fixation System is indicated for use in soft tissue reattachment procedures in the following shoulder procedures:

Bankart repair, SLAP repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, and deltoid repair.

The SnapShot Fixation System is also indicated for supplementary fixation when used in conjunction with a primary fixation device in surgical procedures requiring graft fixation.

The SnapShot Fixation System consists of a SnapShot implant and deployment gun. The SnapShot implant is a PEEK rivet comprised of two components, a cannulated body and a bullet. The SnapShot deployment gun comes packaged pre-loaded with the SnapShot implant and is designed to ease insertion of the SnapShot implant into the bone hole. A reusable deployment gun and reusable drill are also available and can be used with the implant reloads.

The provided text describes a medical device, the SnapShot Fixation System, and its 510(k) premarket notification for FDA clearance. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. This document is a summary of the submission for clearance, not the full study report.

Specifically, the document states:

• "Non-clinical laboratory testing was performed to verify the fixation strength of the SnapShot Fixation System in mechanical pullout testing as compared to the predicate LactoSorb Pop Rivet (K981798) for specific indications for use."
• "The average pullout strength of the SnapShot Fixation System implants was statistically equivalent to or greater than that of the Lactosorb Pop Rivet."
• "When testing supplemental fixation using a resorbable interference screw for primary fixation, the average pullout strength of the construct utilizing the SnapShot Fixation System for supplementary fixation was statistically greater than the construct with no supplemental fixation."
• "Clinical Tests: None provided as a basis for substantial equivalence."

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Non-Clinical Testing (Implied from the text):

Note: The specific numerical values (e.g., in Newtons) for acceptance criteria and performance are not provided in this document. The document only states the comparative outcome ("statistically equivalent to or greater than," "statistically greater than").

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document states "Non-clinical laboratory testing was performed," but does not give the number of samples or specimens tested.
• Data Provenance: The study was a "Non-clinical laboratory testing" (mechanical testing). The country of origin for the data is not explicitly stated, but given the sponsor (Biomet Inc., Warsaw, IN) and the FDA submission, it's highly likely to be conducted in the USA or by labs commissioned by a US company. It is by definition retrospective in relation to the submission date, as the tests were completed before the 510(k) was filed.

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

Not applicable. This was a non-clinical mechanical performance study. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or patient outcomes) is not relevant to this type of testing. The "ground truth" for mechanical testing is established by internationally recognized standards for mechanical testing of medical devices, which are not mentioned in this summary but would have been followed.

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

Not applicable. As this was a non-clinical mechanical performance study, there was no need for expert adjudication of results in the way it's done for clinical or imaging studies. Mechanical test results are typically objective measurements.

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

Not applicable. This device is a physical fixation system (screws/rivets) for soft tissue reattachment, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

Not applicable. This is a physical medical device, not a software algorithm.

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

For non-clinical mechanical testing, the "ground truth" is defined by the physical measurements obtained from calibrated testing equipment under controlled conditions, following established mechanical testing standards (e.g., ASTM, ISO standards for orthopedic implants). These standards themselves can be considered the "ground truth" methodology.

8. The sample size for the training set

Not applicable. This describes a non-clinical mechanical performance study for a physical device, not an AI or machine learning model that would require a 'training set'.

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

Not applicable. See point 8.

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