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The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market Easy Clip. Additional sizes to the existing range and modifications are being made existing cleared Easy Clip' devices (K070031).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Easy Clip" device:

It is important to note that the provided documents are a 510(k) Summary and an FDA clearance letter for a Class II medical device (Staple, Fixation, Bone). For this type of device, the "acceptance criteria" and "study" are typically focused on demonstrating substantial equivalence to an existing legally marketed device (predicate device) through non-clinical testing, rather than performing a clinical trial with specific performance metrics like those for AI/Software as a Medical Device (SaMD).

Therefore, many of the requested categories related to clinical studies, expert-established ground truth, and AI-specific metrics (like MRMC studies) are not applicable to this submission.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

Note: For this type of device, "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity) in the same way as for AI/SaMD. Instead, the acceptance criteria are implicitly that the modified device remains safe and effective, and performs comparably to the predicate device in relevant non-clinical tests. The "reported device performance" is the conclusion that these tests support substantial equivalence.

Study Details

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

   • Sample Size: Not applicable. For non-clinical testing of a medical device like a surgical staple, "sample size" refers to the number of physical units tested for mechanical properties. This specific number is not provided in the 510(k) summary.
   • Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical laboratory testing of the physical device.

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

   • Not Applicable. This submission relied on non-clinical engineering and material tests, not expert-established clinical ground truth. The "ground truth" for these tests would be the established engineering standards (e.g., ASTM F2129) and the characteristics of the predicate device.

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

   • Not Applicable. No human adjudication of clinical cases was performed.

4. 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 is a physical medical device (staple), not an AI/SaMD product. No MRMC study was conducted.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Engineering Standards and Predicate Device Characteristics: The "ground truth" for this submission was based on established engineering and material standards (e.g., ASTM F2129 for corrosion) and the known performance and characteristics of the legally marketed predicate device (K070031). The goal was to demonstrate that modifications did not negatively impact these established benchmarks.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

   • Not Applicable. No training set was used.

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