(90 days)
The DeRoyal non-sterile locking compression plate system is intended for internal fixation of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.
The DeRoyal Non-Sterile Locking Compression Plate System consists of disposable locking plates and screws in either stainless steel or titanium. The plates have alternating holes to accept either cortical, malleolar, shaft, cancellous or locking screws.
The provided text describes a 510(k) summary for the DeRoyal Non-Sterile Locking Compression Plate System. This document focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance through a clinical study with acceptance criteria.
Therefore, many of the requested categories regarding acceptance criteria, study details, expert involvement, and ground truth establishment are not applicable based on the information provided in this 510(k) summary. A 510(k) summary typically references bench testing and comparison to predicate devices, not clinical effectiveness studies with explicit acceptance criteria for device performance as a standalone system.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) summary evaluates "substantial equivalence" to a predicate device, not against specific, pre-defined performance acceptance criteria in a clinical or standalone study. The primary "performance" reported is that the device is "substantially equivalent" to the predicate.
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. This document does not present data from a clinical test set in the way described. Substantial equivalence is typically demonstrated through design, material, and mechanical property comparisons to a predicate device, often leveraging existing data on the predicate.
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. There is no mention of experts establishing ground truth for a test set in this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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 document describes a surgical implant, not an AI-assisted diagnostic device. Therefore, MRMC studies and AI effect sizes are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (surgical plate), not an algorithm or software. Standalone performance as described is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No explicit ground truth is mentioned. The submission relies on establishing equivalence to a legally marketed predicate device. This implies that the predicate device's established safety and effectiveness serve as the "ground truth" to which the new device is compared in terms of design, materials, and intended use.
8. The sample size for the training set:
- Not Applicable. There is no mention of a "training set" in the context of this device. This is not an AI or machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
Summary based on available information:
The 510(k) summary for the DeRoyal Non-Sterile Locking Compression Plate System aims to demonstrate substantial equivalence to predicate devices (Synthes Locking Compression Plates and Synthes Locking Screws). This process primarily involves comparing the new device's design, materials (stainless steel or titanium), manufacturing processes, and intended use to those of the predicate devices. The "study" mentioned, implicitly, is the submission of information that "supports substantial equivalence." This is a regulatory pathway that relies on comparison to existing, legally marketed devices, rather than de novo clinical trials with acceptance criteria for a novel 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.