(133 days)
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:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength Testing | The device should demonstrate comparable tensile strength to the predicate device. | Equivalent time zero tensile strength compared to the predicate. |
| Bending Strength Testing | The device should demonstrate comparable or greater bending strength compared to the predicate device. | Greater bending strength compared to the predicate. |
| Torsion Strength Testing | The device should demonstrate comparable or greater torsional strength compared to the predicate device. | Greater torsional strength compared to the predicate. |
| Shear Strength Testing | The device should demonstrate comparable or greater shear strength compared to the predicate device. | Greater shear strength compared to the predicate. |
| Screw Insertion Testing | Not explicitly stated as a pass/fail criterion in the provided text, but implied as part of demonstrating functional performance. | Implied successful insertion with adequate torque, as driver torque failure loads exceeded required insertion torque. |
| Driver Torque to Failure Testing | The driver/implant interface torque failure loads should exceed the torque required to insert the implants. | Driver/implant interface torque failure loads exceeded the torque required to insert the implants. |
| Association & Disassociation Testing | No disassociation of the implants should be observed during fatigue testing. | No disassociation of the implants was observed during fatigue testing. |
| Four-point Bending Fatigue Testing | The device should demonstrate comparable fatigue performance to the predicate device. | Equivalent fatigue performance compared to the predicate. |
| Tensile Load after Fatigue Testing | The device should demonstrate comparable or greater tensile strength after undergoing fatigue testing when compared to the predicate. | Greater post-fatigue tensile strength compared to the predicate. |
Study Details:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.