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The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The One-Piece PEEK Fusion Implant is manufactured from polyetheretherketone (PEEK). It is threaded on one end and ridged on the other to engage either side of an osteotomy or reconstruction site. The One-Piece PEEK Fusion Implant is threaded into the proximal phalanx and then it is press fit into the middle phalanx, allowing for reduction and fixation of the bone fragments.

This report describes the acceptance criteria and the study proving the device meets those criteria, based on the provided 510(k) summary for the One-Piece PEEK Fusion Implant.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical values for the acceptance criteria and corresponding device performance are not provided in the 510(k) summary. It only states that the device "met the pre-determined acceptance criteria." The summary also mentions that these are "the same tests performed on the predicate device to establish its substantial equivalence in submission K133515."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing described is nonclinical (mechanical/material properties), not clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The described testing is nonclinical mechanical testing, not a study requiring expert-established ground truth on patient data.

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

Not applicable. This was nonclinical testing.

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

No MRMC comparative effectiveness study was mentioned. This device is an implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an implant, not an algorithm.

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

For the nonclinical testing, the "ground truth" would be the engineering or materials science standards and specifications defining acceptable performance for each test (Tensile Strength, Bending Strength, etc.).

8. The sample size for the training set

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

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

Not applicable, as there is no training set for this device.

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The PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The PEEK Fusion Implant is manufactured from polyetheretone (PEEK) and is composed of two threaded components, each designed to engage either side of an osteotomy or reconstruction site. Once in position, the components mate with one another allowing for reduction and fixation of the bone fragments.

The PEEK Fusion Implant underwent non-clinical performance testing to ensure its substantial equivalence to predicate devices and its intended performance.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size for Test Set and Data Provenance:

   • The document states that "All testing was performed on test units representative of finished devices." However, the specific sample size for each mechanical test (e.g., number of implants tested for tensile strength) is not provided.
   • The data provenance is from laboratory testing (non-clinical) conducted by the manufacturer, MTP Solutions LLC. There is no information regarding country of origin, but it is implied to be within the scope of the manufacturer's operations. The testing is described as pre-clinical and therefore inherently retrospective in the context of device design and validation.

2. Number of Experts and Qualifications for Ground Truth:

   • This is a non-clinical mechanical testing study, not a clinical study involving expert assessment of patient data. Therefore, the concept of "experts used to establish ground truth" related to clinical interpretation or diagnosis does not apply. The "ground truth" here is the objective measurement of mechanical properties of the device and its predicates.

3. Adjudication Method:

   • Not applicable as this is a non-clinical mechanical testing study, not a study requiring adjudication of clinical observations or diagnoses. The results are based on objective measurement of physical properties.

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

   • No, an MRMC comparative effectiveness study was not done. This document describes non-clinical mechanical testing of an implantable device, not an AI-assisted diagnostic or interpretive system that would typically use MRMC studies.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This document describes a physical medical device (an implant), not a software algorithm or AI. Therefore, standalone algorithm performance is not relevant.

6. Type of Ground Truth Used:

   • The ground truth for the performance claims derived directly from objective physical measurements and mechanical testing data (e.g., force, torque, displacement) as specified in the various tests (tensile, bending, torsion, fatigue, etc.). This data establishes the inherent properties of the PEEK Fusion Implant and its predicate devices.

7. Sample Size for Training Set:

   • Not applicable. This is a non-clinical mechanical performance study of a physical device. There is no "training set" in the context of machine learning or AI models. The "training" in this context would refer to the engineering design and manufacturing processes, which are not detailed as a "training set" here.

8. How Ground Truth for Training Set Was Established:

   • Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for this device. The physical properties being tested are intrinsic to the manufactured device.

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