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The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

The Stryker SonicPin System consists of a sterile bioresorbable pin (implant), the SonicFusion equipment as well as associated accessories and is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization. The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.

The provided text is a 510(k) Premarket Notification from the FDA for the Stryker SonicPin System. It describes the device, its intended use, indications for use, and summaries of non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Crucially, the document explicitly states: "Clinical testing was not required for this submission."

This means that the device's acceptance criteria and performance were not evaluated through a study involving human subjects or AI-assisted diagnostic performance. Instead, the clearance was based on demonstrating substantial equivalence to a previously cleared predicate device fundamentally through non-clinical testing.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially points 1 through 7, and 9 for a clinical context) cannot be extracted from this document, as a clinical study was not performed.

Here's what can be addressed based on the provided text:

Acceptance Criteria and Device Performance

Since no clinical study was conducted for this 510(k) submission, there are no acceptance criteria related to a diagnostic device's performance (e.g., sensitivity, specificity, or human improvement with AI). The acceptance here is based on the device demonstrating equivalence to its predicate through non-clinical means.

1. A table of acceptance criteria and the reported device performance:

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

• This information is not applicable as no clinical test set was used for patient outcomes or diagnostic performance evaluation. The "test set" would refer to the physical devices subjected to non-clinical mechanical, material, and biocompatibility tests. The provenance of the data is from the manufacturer's (Stryker Trauma GmbH) non-clinical laboratory testing.

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

• Not applicable as no clinical test set requiring expert ground truth for diagnostic or outcome assessment was used.

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

• Not applicable as no clinical test set requiring adjudication was used.

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 bioresorbable pin for bone fixation, not an AI diagnostic tool. No MRMC study was performed.

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 standalone algorithm.

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

• Not applicable for a clinical context. The "ground truth" for this submission was the established performance and safety profiles of the predicate device, against which the modified device's non-clinical performance was compared to demonstrate equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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