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The NexFix™ Compression Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.

The Nexa Orthopedics NexFix™ Compression Staple is made of Stainless Steel intended to be implanted into the bones of the fore foot, mid foot and hind foot. The stables are provided in 21 sizes. The staples are used for fracture fixation, fusion, and osteotomy of the bones of the hand and foot.

The provided document is a 510(k) summary for the Nexa Orthopedics NexFix™ Compression Staple. It states that no clinical testing was performed as a basis for substantial equivalence. Therefore, there are no acceptance criteria, device performance data, or studies that prove the device meets acceptance criteria as typically found in clinical trials.

The substantial equivalence was based on non-clinical laboratory testing and the device having similar design characteristics and intended use to legally marketed predicate devices.

Here's a breakdown based on the information provided, highlighting the absence of clinical study details:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission states "Clinical Testing: None provided as a basis for substantial equivalence." The non-clinical testing results "indicate that the device was functional within its intended use," but specific acceptance criteria and detailed performance metrics from these tests are not provided in this summary.

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

Not applicable. No clinical test set was used for substantial equivalence. For non-clinical testing, the sample size and data provenance are not specified in this summary.

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

Not applicable. No clinical test set requiring expert-established ground truth was used for substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was performed for substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant (compression staple), not a software algorithm, so the concept of standalone algorithmic performance is irrelevant.

7. Type of Ground Truth Used

Not applicable for clinical studies. For the non-clinical testing that was performed, the "ground truth" would be engineering specifications and mechanical testing standards, but the specific details are not provided in this summary.

8. Sample Size for the Training Set

Not applicable. No training set was used as no clinical study or algorithm development was detailed for this 510(k) submission.

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

Not applicable. No training set was used.

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