(491 days)
Intended use for fixation of complex intra and extra-articular fractures and osteotomies, selective trauma, reconstructive procedures, fusions osteotomies, non-unions, replantations, complex extra articular fractures and fusions of bones of the anatomical regions of the hand, foot and ankle, particularly for osteopenic bone in adults and adolescents.
The Truemed Hand, Foot and Ankle Plates System consist in a variety of plates designed for specific bone areas, with orifices to receive either locking or non- locking screws. The screws can be total or partially threaded, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either Stainless Steel (ASTM 138 - 13a) or Titanium (ASTM F136-12a).
This document is a 510(k) Premarket Notification for a medical device called the "Truemed Hand, Foot and Ankle Plates System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
This document describes a medical device (plates and screws for bone fixation) and its equivalence to other similar devices based on engineering and mechanical testing, NOT an AI/ML powered device, therefore the request regarding acceptance criteria and study proving it meets acceptance criteria for an AI/ML device is not applicable.
However, I can extract the information provided about the device's testing and safety:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Plates: | |
| Static bending yield strength | Proved to be as strong as predicate devices |
| Static torsional yield strength | Proved to be as strong as predicate devices |
| Screws: | |
| Torsional properties | Performed in accordance with ASTM F543 ANNEX: A1 |
| Insertion and Removal Torque | Performed in accordance with ASTM F543 ANNEX: A2 |
| Axial Pullout Strength | Performed in accordance with ASTM F543 ANNEX: A3 |
| Materials: | |
| Stainless Steel (ASTM 138-13a) | Meets specifications and chemical/physical characteristics for medical implants according to ISO 5832 |
| Titanium (ASTM F136-12a) | Meets specifications and chemical/physical characteristics for medical implants according to ISO 5832 |
| Biocompatibility | Biocompatibility risk assessment performed for all components |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size used for the mechanical and engineering tests, nor does it mention data provenance (country of origin, retrospective or prospective).
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)
- This information is not applicable and not provided. The "ground truth" in this context is the performance relative to established material standards and predicate devices, assessed through engineering and mechanical testing, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. The "test set" here refers to physical components undergoing mechanical and engineering evaluation, not clinical data requiring 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
- This information is not applicable. This is a medical device for bone fixation, not an AI/ML powered diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is a medical device for bone fixation, not an AI/ML powered algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by engineering analyses, mechanical testing against material standards (ASTM, ISO), and direct comparison to the physical and functional characteristics of legally marketed predicate devices.
8. The sample size for the training set
- This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- This information is not applicable. There is no "training set."
§ 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.