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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 dynaMX™ Intramedullary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The dynaMX™ Intramedullary Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges. The implant is fully cannulated with threads on the distal side and two barbs on the proximal side. The implant is offered in multiple combinations of diameter and length to accommodate various anatomies. The dynaMX™ Intramedullary Implant is made of biocompatible Nitinol. The barbs of the implant are designed to exhibit superelastic properties at room and body temperature. As manufactured, one end of the implant has a screw thread, and the other end a pair of barbs. The screw thread is inserted into a drilled hole in the middle phalange. The barbed end is implanted into a broached canal in the proximal phalange. While inserting the barbed end of the implant, the barbs deflect inward to allow the implant to pass through the broached canal. Once inside the canal, the barbs superelastically return to their flared outward configuration to securely hold the implant in the bone. The dynaMX™ Intramedullary Implant is sold as part of a single use disposable kit. The kit includes an implant, pre-loaded onto a delivery device, a drill bit, a broach and a quide wire.

The provided document is a 510(k) premarket notification for a medical device called the "dynaMX™ Intramedullary Implant." This type of document is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not contain detailed acceptance criteria and study results in the same way a clinical trial report would.

However, based on the information provided, I can infer what constitutes the "acceptance criteria" through the bench and cadaver testing listed and how the device aims to meet these through comparison with predicate devices.

Here's an analysis based on your request, structured as much as possible with the available information:

Key Takeaway: The document outlines a substantial equivalence claim based on laboratory studies (bench and cadaver tests) rather than human clinical trials involving complex statistical criteria for AI performance. Therefore, many of your specific questions related to AI-specific metrics, human reader studies, and large-scale data provenance are not applicable to this type of device and submission.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for the dynaMX™ Intramedullary Implant are demonstrated through a series of laboratory studies (bench tests and cadaver tests) designed to verify the suitability of the device for its intended use, establish substantial equivalence with predicate devices, and confirm reproducibility of packaging. The successful completion of these tests, showing comparable performance to predicate devices, serves as the primary evidence for meeting acceptance criteria for this Class II medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for the bench and cadaver tests. It generally states a "series of laboratory studies." For cadaver tests, typically a limited number of cadaveric specimens would be used.

The data provenance is laboratory-based (bench tests) and cadaveric. There is no information regarding country of origin, but it is assumed the tests were conducted within the facilities of Arthrex, Inc. (or MX Orthopedics, Corp.) or their designated testing laboratories. These are effectively retrospective in the sense that they are conducted on inert materials or cadaveric tissue in a controlled lab setting, not in live patients.

3. Number of Experts Used to Establish the Ground Truth For The Test Set and Qualifications of Those Experts

This information is not applicable as the device is an implantable mechanical device, not an AI or diagnostic device that relies on expert ground truth for interpretation of output. The "ground truth" for this device's performance would be the physical properties and mechanical behavior observed in the specified laboratory tests.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication typically refers to expert consensus in interpreting diagnostic results or clinical outcomes. The performance of this device is assessed directly through engineering measurements and established material science principles in laboratory settings.

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 information is not applicable. This device is a surgical implant, not a diagnostic or AI-powered system, and therefore, human reader studies with AI assistance are irrelevant to its evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is a physical implant; there is no algorithm involved in its direct function for standalone performance evaluation in this context.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily engineering specifications, material science properties, and established biomechanical performance standards for bone fixation devices. This is demonstrated through direct physical measurements and observations during bench and cadaver tests. The comparison to predicate devices also establishes a benchmark for "ground truth" in terms of acceptable clinical performance and safety.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical implant, not a machine learning model, so there is no "training set."

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

This information is not applicable. There is no "training set" for this type of device.

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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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