(328 days)
The AOS Clavicle Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle.
The AOS Clavicle Plate system consists of bone plates and screws for fractures, fusions, and osteotomies of the clavicle bone. The bone plates are pre-shaped to fit the curves and angles of the clavicle and are provided in small, medium and large sizes. The plate accepts both locking and nonlocking screws.
The provided text describes the AOS Clavicle Plate System and its substantial equivalence to predicate devices, focusing on mechanical testing rather than AI/software performance. Therefore, many of the requested criteria (e.g., sample size for test/training sets, expert qualifications, multi-reader multi-case studies) are not applicable or cannot be extracted from this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Results) |
|---|---|
| Static 4-point bend testing (in accordance with ASTM F382) | Results demonstrate that the subject device is substantially equivalent to the predicates. |
| Dynamic 4-point bend testing (in accordance with ASTM F382) | Results demonstrate that the subject device is substantially equivalent to the predicates. |
2. Sample size 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 for the mechanical tests. The provenance of the data is not explicitly mentioned beyond being "PRECLINICAL TESTING" conducted to compare with predicate devices. This is a technical/mechanical study, not a clinical study involving 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. This is a physical device subject to mechanical testing, not a diagnostic or AI device requiring expert interpretation of medical images to establish ground truth. The "ground truth" here is the performance metrics derived from the ASTM F382 standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, typically in clinical or diagnostic contexts. This is a mechanical testing study.
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
Not applicable. This device is a bone plate system, not an AI or diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (bone plate), not an algorithm or software. Its performance is inherent in its physical and mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by validated mechanical testing standards (ASTM F382). The device's performance is compared against the performance of predicate devices as measured by these same standards to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.
§ 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.