(22 days)
The Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius.
The Sterile DVR Anatomic Plating System offers the DVR plating system of plates and screws in a sterile configuration.
The provided text is a 510(k) summary for the DePuy Sterile DVR Anatomic Plating System. This document focuses on establishing substantial equivalence to a predicate device, primarily through bench testing, rather than presenting a clinical study with detailed acceptance criteria for an AI/device performance.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or available in this specific document.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance:
Since this is a submission for a bone fixation device, the "acceptance criteria" are not reported as statistical performance metrics of an AI or diagnostic device. Instead, the acceptance criterion for substantial equivalence is met through bench testing, demonstrating that the device performs comparably to the predicate device.
| Acceptance Criteria / Performance Metric (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Device | Equivalence confirmed through bench testing. |
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. This document refers to "bench testing," which typically involves mechanical or physical tests on the device hardware, not a "test set" of patient data in the context of an AI or diagnostic study.
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. The ground truth for bench testing is typically based on engineering specifications and physical measurements, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation of data, which is not described for this submission.
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. An MRMC study was not done, as this is a physical medical device (bone plating system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated, but implied from "bench testing": For a medical device like a bone plate, ground truth would relate to the mechanical properties, material composition, and functional performance (e.g., strength, fatigue resistance, fixation stability) derived from engineering standards and test protocols.
8. The sample size for the training set:
- Not applicable/Not provided. This document describes a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This document describes a physical medical device, not a machine learning model.
§ 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.