(159 days)
The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation surgeries of the foot in adults.
The Footmotion Plating System consists of a plate with as many screws as holes (slots) designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The plates and screws are manufactured from titanium alloy and color anodized. The Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.
This document is a 510(k) summary for the Footmotion Plating System, a metallic bone fixation device. As such, it does not describe a study proving software performance against well-defined acceptance criteria for an AI/ML medical device. It's for a physical implantable device.
Therefore, many of the requested categories related to AI/ML device studies, such as sample size for test set and training set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable to this document.
However, I can extract the information relevant to this device's non-clinical testing and acceptance criteria as described:
1. A table of acceptance criteria and the reported device performance:
| Test Type | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Comparative Fatigue Compression Tests | ASTM F382 | Subject devices met the standard (implied by conclusion of substantial equivalence to predicates that meet this standard) |
| Comparative Static Tests | ASTM F382 | Subject devices met the standard |
| Torsional Tests | ASTM F543 | Subject devices met the standard |
| Endotoxin Testing | LAL quantitative kinetic chromogenic method; max 20 EU per device | Demonstrated devices meet the recommended maximum endotoxin level of 20 EU per device |
| Water Endotoxin Level (for cleaning) | Max limit 0.25 EU/mL | Never reached the maximum limit of 0.25 EU/mL |
| Bioburden, TOC, THC (for water) | Not explicitly stated | Testing performed, values not specified but implied to be acceptable for cleaning water |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. These are non-clinical mechanical and material tests, not a clinical study or AI/ML evaluation. The tests are performed on representative samples of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth as typically understood for AI/ML devices is not relevant for these types of mechanical and material tests. Compliance with established ASTM standards and endotoxin limits forms the 'ground truth' or acceptance criteria for these tests. Engineering analysis is performed by qualified engineers, though their specific number and qualifications are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
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 document specifies "No clinical studies were performed." This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an algorithm or AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's non-clinical testing is based on:
- Compliance with recognized industry standards (ASTM F382, ASTM F543).
- Quantitative measurements against established limits (e.g., endotoxin levels).
- Engineering analysis.
8. The sample size for the training set:
Not applicable. No AI/ML component; therefore, no training set.
9. How the ground truth for the training set was established:
Not applicable. No AI/ML component; therefore, no training set or ground truth for one.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.