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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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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).

The PHALINX® Hammertoe System implants are a single piece titanium device offered in straight cannulated and 10° solid options. The implants have proximal and distal fixation features and are offered in multiple sizes. This submission seeks to add PHALINX® K-Wires to the system for use with cannulated implants. The PHALINX® K-wires are offered in surgical grade stainless steel. A range of diameters and lengths are offered from the manufacturer and planning should be conducted prior to implantation to determine the best fit.

This document is a 510(k) premarket notification for a medical device called the "PHALINX® Hammertoe System." It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria as would be expected for an AI/software as a medical device (SaMD).

This document is for a physical orthopedic implant system, not a software or AI device. Therefore, the requested information categories regarding acceptance criteria, performance studies, sample sizes, ground truth, experts, and MRMC studies, which are typical for SaMD, are not applicable here.

The document primarily focuses on establishing "substantial equivalence" to predicate physical devices, meaning it is similar enough in design, materials, and intended use that it does not raise new questions of safety or effectiveness.

Here's a breakdown of what is available in the document, framed against your request, to highlight the absence of SaMD-specific information:

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

   • Not applicable / Not present. This submission does not provide acceptance criteria for a performance study as might be done for SaMD. Instead, it relies on substantial equivalence.
   • The document states: "Testing related to bending and pull-out strength was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical." This implies that the current device is considered to meet the same performance characteristics as its predicates based on its identical design.

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

   • Not applicable / Not present. There is no "test set" in the context of an AI/software evaluation.

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):

   • Not applicable / Not present. "Ground truth" in the context of an AI/software evaluation is not relevant for this physical device submission.

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

   • Not applicable / Not present.

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 / Not present. MRMC studies are specific to evaluating AI in diagnostic contexts.

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

   • Not applicable / Not present. This is a physical implant, not an algorithm.

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

   • Not applicable / Not present.

8. The sample size for the training set:

   • Not applicable / Not present. No "training set" for an algorithm.

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

   • Not applicable / Not present.

Summary of Device and its Basis for Clearance:

• Device Name: PHALINX® Hammertoe System
• Intended Use: Fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants can be used with K-wires for delivery or temporary stabilization of outlying joints.
• Device Description: Single-piece titanium device (straight cannulated and 10° solid options) with proximal and distal fixation features, offered in multiple sizes. This submission specifically adds PHALINX® K-Wires (surgical grade stainless steel) for use with cannulated implants.
• Basis for Clearance (Substantial Equivalence): The device design is stated to be "identical to the currently marketed PHALINX® Hammertoe System." Therefore, new performance testing (like bending and pull-out strength) was not provided, as it was previously submitted for the predicate device.
• Clinical Evidence: "N/A" (Not Applicable)
• Conclusion: The design characteristics "do not raise any new types of questions of safety or effectiveness." The device is expected to perform "at least as well as the predicate device."

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The PhaLinx® Hammertoe System is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

The PhaLinx® Hammertoe System implants are a single piece titanium device offered in straight cannulated and 10° solid options. The implants have proximal and distal fixation features and are offered in multiple sizes.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) premarket notification for the PhaLinx Hammertoe System, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria.

Specifically, the text does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, its data provenance, or the number/qualifications of experts for ground truth.
• Adjudication method.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set or how its ground truth was established.

The document only states that "Testing related to bending and pull-out strength were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system." and that "The safety and effectiveness of the PhaLinx® Hammertoe System is adequately supported by the mechanical testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification." This is a general statement about the type of testing performed, not a detailed report of study findings against specific acceptance criteria.

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