(37 days)
Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions.
Periarticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.
Periarticular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
The Zimmer Periarticular Plating System consists of temporary implants (plates and screws) and instrumentation for the management of periarticular bone fractures through interfragmentary compression and bone plating. Bone screws are provided for use with or without bone plates for fractures. This submission covers non-sterile versions of previously cleared sterile Zimmer Periarticular Plating System screws and various sizes of the following sterile plates: Distal Volar Radial Radius, Distal Volar Ulnar Radius, Lateral Calcaneal.
This document is a 510(k) premarket notification for the Zimmer Periarticular Plating System. It describes the device, its intended use, and its substantial equivalence to predicate devices. The information provided is primarily related to regulatory approval and does not contain details about a study designed to prove the device meets specific acceptance criteria in terms of diagnostic performance or clinical outcomes.
Here's a breakdown of why the requested information cannot be fully provided based on this document:
- Type of Device: The Zimmer Periarticular Plating System is a medical implant (plates and screws for bone fixation), not a diagnostic device or an AI-powered system that would typically undergo performance studies with acceptance criteria like sensitivity, specificity, or reader studies.
- Regulatory Pathway: This is a 510(k) submission, indicating a claim of substantial equivalence to already legally marketed predicate devices. This pathway primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, rather than requiring extensive de novo clinical trials to prove efficacy against acceptance criteria.
Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory document.
However, I can extract the information that is present and explain why other points are not.
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in the sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or detailed clinical outcome success rates for a study designed to prove the device meets those criteria. Instead, the "performance" described is about non-clinical aspects related to safety and function for substantial equivalence.
| Performance Aspect | Reported Device Performance |
|---|---|
| Shelf Life | 10 years (based on accelerated aging testing) |
| Biocompatibility | All testing passed (per ISO 10993-1 and 21 CFR 58 GLP) |
| Mechanical Performance | Demonstrated safe and effective, and substantially equivalent to predicate devices (via engineering analysis) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The performance data is based on non-clinical testing (shelf life, biocompatibility, engineering analysis), not human clinical data with a "test set" of patients.
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 was no clinical test set for which ground truth needed to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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 is not an AI-powered or diagnostic device. 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 not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable to the clinical performance. For the non-clinical performance:
- Shelf Life: Determined by laboratory accelerated aging protocols.
- Biocompatibility: Determined by laboratory testing against ISO 10993-1 and 21 CFR 58 GLP.
- Mechanical Performance: Determined by engineering analysis and comparison to predicate device specifications and performance.
8. The sample size for the training set
Not applicable. This is not a device developed through machine learning.
9. How the ground truth for the training set was established
Not applicable.
§ 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.