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The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of ostectomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the PRO-TOE® X-FLEX, can be used with Implantable K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint),

The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

The PRO-TOE® Hammertoe Fixation System is composed of implants and instruments intended for use in the fixation or reconstruction of the lesser toes. The implants within the PRO-TOE® Hammertoe System have proximal & distal fixation features and are offered in multiple sizes. The implants are manufactured from stainless steel and titanium alloy.

This FDA 510(k) summary describes a medical device, the PRO-TOE® Hammertoe Fixation System - C2 Implant Line Addition. It is a premarket notification for a new version of an existing device, adding new sizes and updating design. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study of its performance against acceptance criteria in the way a novel device might.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) submission for a device modification, the "acceptance criteria" are often implicitly tied to demonstrating equivalence to an existing legally marketed device (the predicate). The primary acceptance criterion is that the new device is "substantially equivalent" to the predicate, meaning it performs as intended and does not raise new questions of safety or effectiveness. The reported performance here directly addresses this by stating that the mechanical testing (pullout and static bend) confirms the absence of a new worst-case scenario and that the device is expected to perform "at least as well" as the predicate.

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of implants or test repetitions for the pullout and static bend testing. The analysis refers to "the subject implants" generally.
• Data Provenance: The document (a 510(k) summary) does not specify the country of origin of the data. The testing described would typically be conducted in a laboratory setting, likely at the manufacturer's facility or a contracted testing lab. The study is non-clinical.

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

• This information is not applicable to this type of submission. The "ground truth" for mechanical testing is based on engineered specifications and established test methods, not expert consensus on interpretations of data or images. The "experts" would be the engineers and technicians performing and interpreting the mechanical tests.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for situations involving human interpretation (e.g., medical imaging, clinical assessments) where there might be disagreement among reviewers. Mechanical test results are typically objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study is a clinical study involving multiple human readers assessing medical cases, often to compare diagnostic accuracy or treatment effectiveness. This submission for a bone fixation system modification relies on non-clinical (mechanical) testing and demonstration of substantial equivalence, not a clinical MRMC study.

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

• Not applicable. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the non-clinical testing (pullout and static bend) would be defined by established engineering principles, material science, and relevant ASTM/ISO standards for mechanical testing of medical implants. The performance is compared against the known performance of the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This refers to a physical medical device, not a machine learning algorithm.

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

• Not applicable. This refers to a physical medical device, not a machine learning algorithm.

Summary and Key Takeaways from the Document:

This 510(k) filing for the PRO-TOE® Hammertoe Fixation System - C2 Implant Line Addition is characteristic of a submission for a device modification rather than a completely novel device or an AI/software as a medical device (SaMD). The core of the submission is to demonstrate substantial equivalence to existing predicate devices (K132895 and K140148).

Therefore, the focus is on:

• Comparing the technological characteristics (materials, design, intended use).
• Presenting non-clinical evidence (mechanical testing like pullout and static bend) to show that the modified device performs at least as well as the predicate and does not introduce new safety concerns ("do not present a new worst case").
• Explicitly stating that no clinical evidence (human studies) was required for this demonstration of substantial equivalence.

The requested information about experts, adjudication, MRMC studies, standalone algorithm performance, and training/test set sample sizes (in the context of AI/ML) is generally not relevant to this type of device and 510(k) submission.

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The PRO-TOE® Hammenoc Fixation Systems are indicated for the fixation of ostconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PRO-TOE® Hammerton Fixation Systems can be used with K-wires for the delivery of implants of the temporary stabilization of outlying joints (c.g. MTP Joint).

The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for inscrion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteonomics and reconstruction of the lesser toc following correction procedures for hammerloe, claw toe, mallet toe, and metatarsophalangeal joint instability.

The PRO-TOE® Hammetoe Fixation System is composed of implants and instruments intended for use in the fixation or reconstruction of the lesser toes. The implants within the PRO-TOE® Hammertoe System have proximal & distal fixation features and will be offered in multiple sizes. The implants are manufactured from stainless steel or titanium.

This submission seeks to add previously cleared WMT Implantable K-Wires to the system for use with cannulated implants, for which clearance is also sought in this submission. The WMT Implantable 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.

The provided document is a 510(k) summary for the PRO-TOE® Hammertoe Fixation System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study details, and AI performance metrics is not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of what can be inferred or explicitly stated based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission like this is typically substantial equivalence to legally marketed predicate devices. This means the new device performs at least as well as the predicate and does not raise new questions of safety or effectiveness. Specific quantifiable performance criteria (e.g., success rates, complication rates) are generally not established or reported in this type of document for new predicate devices.
• Reported Device Performance: The document states that "Mathematical mechanical analysis related to static bend testing has shown that the subject implants do not present a new worst case." This is the only performance-related statement, indicating that the mechanical properties are at least equivalent to or better than the predicate in certain aspects. No clinical performance metrics are provided.

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

• Not Applicable. This submission relies on a non-clinical "mathematical mechanical analysis" rather than a clinical "test set" with human or animal subjects. Therefore, there's no sample size or data provenance in the context of clinical testing.

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

• Not Applicable. No clinical test set or human-based ground truth establishment is described. The assessment is based on engineering analysis.

4. Adjudication Method for the Test Set:

• Not Applicable. As there is no clinical test set, there is no adjudication method.

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

• No. This document does not mention an MRMC comparative effectiveness study. It's a submission for a mechanical implant, not a diagnostic or AI-driven imaging device.

6. Standalone (Algorithm Only) Performance Study:

• No. This is not an AI-driven device or algorithm. The submission pertains to a physical implant.

7. Type of Ground Truth Used:

• The "ground truth" here is the performance of the predicate device as established through its existing regulatory clearance and assumed safety and effectiveness. The new device demonstrates "substantial equivalence" based on similar materials, indications, dimensions, geometry, and non-clinical mechanical testing that shows it doesn't present a "new worst case."

8. Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.

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

• Not Applicable. As above, no training set exists for this type of device.

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

The document describes a non-clinical study involving mathematical mechanical analysis related to static bend testing. This analysis was conducted to compare the new PRO-TOE® Hammertoe Fixation System implants (specifically the PRO-TOE® VO Cannulated and PRO-TOE® C2 implants) against their legally marketed predicate device (K101165 – PRO-TOE™ VO Hammertoe Implant System and K120645 - PRO-TOE™ Hammertoe Implant System).

The purpose of this study was to demonstrate that the mechanical properties of the subject implants, in terms of static bending, do not present a new worst case compared to the predicate devices. This finding, along with the similarities in indications, materials (stainless steel or titanium), dimensions, and geometry, allowed Wright Medical Technology, Inc. to conclude that the device is substantially equivalent to the predicate devices and does not raise new questions of safety or effectiveness. No human or animal subjects were involved in this specific study.

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