(43 days)
The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.
The Hammer Toe Implant is a threaded/spaded device used for bone fixation in the phalanges of the lesser digits in the foot and hand. The implant, which is a cannulated, threaded and spaded device, is offered in multiple diameters and lengths. The system will also consist of K-wires (K121008) to be used in the delivery of the implant and also for use of temporary stabilization of outlying joints.
Here's a summary of the acceptance criteria and the study information for the Trilliant Hammer Toe Implant, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Static axial pull-out of threaded portion from polyurethane foam test block | Equivalent to predicate devices |
| Static axial pull-out of barbed (spade) section from polyurethane foam test block | Equivalent to predicate devices |
| Driving torque into polyurethane foam test block | Equivalent to predicate devices |
| Static testing to determine failure torque | Equivalent to predicate devices |
Study Information
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Sample size used for the test set and the data provenance: Not applicable. The study was non-clinical (mechanical testing) and did not use patient data. The test material was polyurethane foam.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established by physical properties and mechanical testing standards (ASTM F543).
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Adjudication method for the test set: Not applicable.
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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 study was performed. This is a medical device (implant), not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance was assessed. This is a medical device (implant), not an AI diagnostic tool.
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The type of ground truth used: Mechanical properties and performance evaluated against ASTM F543 standards, demonstrating equivalence to predicate devices. This is a form of engineering or physical ground truth.
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The sample size for the training set: Not applicable. No training set was involved as this was a non-clinical mechanical performance study for a physical implant.
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How the ground truth for the training set was established: Not applicable.
§ 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.