(251 days)
Trauson Bone Plate is intended for the fixation of fractures of humerus.
The applicant device of Trauson Bone Plate made of medic 11 grade 3 16L stainless steel that meet ASTM F138 is intended for the fixation of fractures of humerus. The plates vary essentially through different lengths, number of plate holes. The applicant devices are not sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.
The provided text describes a submission for a medical device called "Trauson Bone Plate" and its substantial equivalence to a predicate device. However, it does not contain the detailed information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML or diagnostic device.
This document pertains to a Class II metallic bone fixation appliance, which is a physical implant, not an AI/ML system or a diagnostic device that would have performance metrics like sensitivity, specificity, or AUC against a ground truth.
Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of device and are not present in the provided text.
Based on the information given, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (Bending Proof Load) | Determined by bench tests following ASTM F382. |
| Mechanical Strength (Run-out Load) | Determined by bench tests following ASTM F897. |
| Material Biocompatibility | Made of medical grade 316L stainless steel meeting ASTM F138. Materials are widely used and have known biocompatibility. No new materials. |
| Substantial Equivalence to Predicate Device (K041965) | Declared "Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety." |
| Intended Use | Fixation of fractures of humerus. |
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 / Not provided. The tests mentioned are bench tests on the physical device components, not studies on patient data.
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 / Not provided. Ground truth, in the context of diagnostic performance or AI, is not relevant for a bone plate's mechanical and material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication is not relevant for bench testing of material properties.
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 type of study is entirely irrelevant for a bone fixation plate.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground truth for mechanical/material properties: Adherence to established ASTM standards (F138 for material, F382 and F897 for mechanical tests). The "ground truth" here is the specified performance criteria defined by these standards.
8. The sample size for the training set:
- Not applicable / Not provided. There is no "training set" for a physical medical device in this context.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. There is no "training set" or "ground truth" in the AI/ML sense. The ground truth for the device's properties is based on industry-standard material and mechanical testing protocols.
§ 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.