(90 days)
The DVR® Crosslock Wrist Spanning Plate is indicated for skeletally mature patients for fixation of fractures, osteotomies and non-unions of the distal radius.
The DVR® Crosslock Wrist Spanning Plate is a single-use plate for the fixation of fractures, osteotomies and non-unions of the distal radius. The plate spans the patient's wrist and is placed from the radial shaft to the second or third metacture pattern and patient anatomy. The plate provides ligamentotaxis on a temporary basis while the distal radius heals. The DVR® Crosslock Wrist Spanning Plate consists of a single, sterile-packed plate and is manufactured from titanium alloy (Ti-6AL-4V). The plate features hole clusters consisting of locking screw holes, a central screw cluster, and K-wire holes for preliminary fixation. There is a dorsal bend at the distal end of the plate to accommodate patient anatomy.
The provided document describes a medical device called the "DVR® Crosslock Wrist Spanning Plate" and its clearance through the FDA 510(k) pathway. This pathway does not typically involve clinical studies proving novel efficacy, but rather substantial equivalence to a predicate device. Therefore, the information requested regarding acceptance criteria and studies specifically proving the device's performance in a clinical context (e.g., effect size with AI assistance, expert consensus, training set details) will not be present.
Instead, the document details non-clinical testing to demonstrate substantial equivalence to a predicate device.
Here's the information extracted from the document, focusing on the available details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by Predicate Device) | Reported Device Performance |
|---|---|
| Static Testing: | |
| Bending structural stiffness | Passed |
| Bending strength | Passed |
| Fatigue Testing: | |
| Fatigue runout | Met acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The testing described is non-clinical, involving mechanical testing of the device itself, not human subjects or patient data.
- Data Provenance: Not applicable. The testing was laboratory-based mechanical testing.
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. The ground truth for mechanical testing is established by engineering standards and measurements, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human interpretation or clinical trials, not mechanical performance testing.
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 MRMC comparative effectiveness study was done for this device, as it is a bone fixation plate, not an AI-powered diagnostic or assistive technology.
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)
- The "ground truth" for this device's performance evaluation was based on accepted engineering standards and the performance of a predicate device as defined by ASTM F382-17 (Standard Specification and Test Method for Metallic Bone Plates).
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning or a "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.