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The PHALINX™ Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PHALINX™ Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a gamma sterilized version of the PHALINX Hammertoe system. The subject PHALINX® Hammertoe System implants are designed to facilitate fixation of osteotomies and reconstruction of the lesser toes. The implants have barbed proximal and interrupted distal threads fixation features and are offered in multiple sizes. The subject PHALINX hammertoe implant is single piece titanium device offered in straight cannulated and angled 10° solid options and remains identical to the predicate in design. The subject cannulated hammertoe implanted temporarily with k-wires (0.9, 1.1, 1.4 mm) to stabilize outlying joints. These k-wires were originally cleared under K 142585 and a minor modification to the length of the k-wire is being made in this submission.

This document describes a 510(k) premarket notification for the Sterile PHALINX Hammertoe System. This submission primarily focuses on introducing a gamma-sterilized version of an already cleared device and making a minor modification to the length of k-wires.

Therefore, the information typically associated with complex AI/ML device studies (like those involving acceptance criteria for diagnostic performance, multi-reader multi-case studies, or extensive ground truth establishment) is not applicable or present in this context. This is a submission for a physical orthopedic device, not an AI/ML algorithm.

Here's the breakdown of the requested information based on the provided text, highlighting what is missing or not applicable:

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

The provided document does not contain a table of acceptance criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it discusses the results of non-clinical tests to demonstrate equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this submission is for a physical orthopedic device and does not involve a "test set" of patient data for performance evaluation in the context of AI/ML. The "testing" refers to non-clinical laboratory evaluations of the device's physical properties and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. "Ground truth" in the context of clinical expert consensus for AI/ML performance evaluation is not relevant for this device submission.

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

This is not applicable. There was no "test set" requiring adjudication in this context.

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

This is not applicable. An MRMC study is relevant for diagnostic or AI-assisted devices that involve human interpretation. This submission is for a surgical implant.

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

This is not applicable. This is not an algorithmic or software-only device.

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

This is not applicable. As explained above, "ground truth" in the context of clinical AI/ML studies is not relevant here. The evaluation relies on established engineering standards and tests.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" or "ground truth" in this context.

Summary of the Study that Proves the Device Meets the "Acceptance Criteria"

The study primarily supporting this 510(k) submission consists of non-clinical testing to demonstrate the substantial equivalence of the Sterile PHALINX Hammertoe System to its predicate device (PHALINX Hammertoe, K150252). The key aspects of this study were:

• Pyrogenicity Testing: Performed using the bacterial endotoxins test on the subject device according to ANSI/AAMI ST 72. This demonstrates the device's acceptable level of pyrogens, a critical safety aspect for implants.
• MR Compatibility Evaluation: Engineering analysis was conducted to assess the magnetic resonance (MR) compatibility of the device. This involved evaluating:
  • RF Heating per ASTM F2182.
  • Induced Force / Induced Torque per ASTM F2062 and ASTM F2213.
  • Image Artifact per ASTM F2119.
    These tests ensure the device is safe for patients undergoing MRI procedures and does not significantly interfere with image quality.
• Design and Material Comparison: The submission explicitly states that the subject PHALINX hammertoe implants are "identical to the predicate in implant design, material, and intended use." Minor modification was made to k-wire length.
• Sterilization Method Change: The primary change is the introduction of a gamma-sterilized version. The non-clinical testing data supports the safety and effectiveness of this sterilization method for the device.

Clinical testing was not required for this submission because the device is substantially equivalent in design, material, and indications for use to an already cleared predicate device, with the main difference being the sterilization method and a minor k-wire length adjustment, which are addressed through non-clinical performance data and established regulatory pathways.

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