(197 days)
The implants of the Footmotion Hammer Toe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.
The Footmotion HammerToe range consists of intramedullary implants designed for proximal interphalangeal arthrodeses of lesser toes in adults. The Footmotion HammerToe range will be provided non sterile for health sterilization bv care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136-13 and ISO 5832-3). Function: The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.
This document is a 510(k) Summary for a medical device called the "Footmotion HammerToe." It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
The information provided does not include acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML device, as this is a traditional medical device (an implant).
Here's an analysis based on the provided text, aligning with your request, but highlighting the differences for a non-AI/ML device:
1. Table of acceptance criteria and reported device performance:
Since this is an orthopedic implant, the "acceptance criteria" and "device performance" are not about AI model metrics like sensitivity or specificity. Instead, they refer to the physical and mechanical properties of the implant. The document states that the device is substantially equivalent to predicate devices based on:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition (Biocompatibility & Strength) | Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136-13 and ISO 5832-3) |
| Mechanical Performance (Resistance to Flexion & Pull-out) | Passed "Flexion tests" and "Pull out tests" |
| Functionality (Ability to fix bone for arthrodesis) | Implants are intended for proximal interphalangeal arthrodeses of lesser toes in adults. |
| Sterilization Compatibility | Provided non-sterile for health sterilization by care professionals prior to use, or provided sterile by gamma sterilization. |
| Substantial Equivalence to Predicate Devices (Overall) | Claimed substantial equivalence in terms of intended use, design, materials used, mechanical safety and performance. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample size for test set: Not applicable in the context of an AI/ML model. The "tests" mentioned are biomechanical tests on the device itself, not clinical data.
- Data provenance: Not applicable for this type of device. The tests were performed on the physical implant. The manufacturer, NEWCLIP TECHNICS, is based in France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of this device refers to established engineering standards (ASTM, ISO) for material properties and performance. Biomechanical testing doesn't typically involve human experts establishing "ground truth" for the test results in the same way an AI model might. The "experts" would be engineers designing and conducting the tests according to established protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human review of data to establish ground truth, not to physical device 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. This is an orthopedic implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (flexion, pull-out), the "ground truth" is defined by established engineering standards and material specifications (ASTM F136-13 and ISO 5832-3 for the material) and the expected mechanical behavior for an implant of this type, as demonstrated by predicate devices. The tests aimed to show that the device meets these physical and mechanical performance expectations.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the study/evidence for device acceptance:
The device's acceptance is based on a non-clinical study involving mechanical testing:
- Flexion tests
- Pull out tests
The purpose of these tests was to demonstrate the mechanical safety and performance of the Footmotion HammerToe range. The conclusion drawn is that the device is substantially equivalent to legally marketed predicate devices (Memometal Intra-medullary Bone Fastener, Pro-Toe Vo Hammertoe Implant System, Nextra Ti Hammertoe Correction System) based on:
- Similar principles of operation
- Similar technology
- Similar materials
- Similar indications for use
The submission explicitly states: "No clinical studies were performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.
§ 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.