(27 days)
The Dorsal Nail Plate™, Anatomical is intended for the fixation of fractures and osteotomies involving the distal Radius.
The Dorsal Nail Plate™, Anatomical is intended to treat fractures in both left and right Radius. The distal segment of the nail plate is intended to be attached to the dorsal surface of the distal Radius. The proximal segment of the nail plate is intended to be inserted into the Radial shaft.
This document describes a medical device called the "Dorsal Nail Plate™, Anatomical" for bone fixation, and not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device, such as sample size, ground truth establishment, expert qualifications, and AI-specific comparative effectiveness studies, is not applicable to this submission.
The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval.
Here's an analysis of the provided information in relation to the query:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in terms of intended use, materials, biocompatibility, and overall performance characteristics.
- Reported Device Performance: The document states that "The equivalence was confirmed through pre-clinical testing." No specific performance metrics or thresholds are explicitly provided in the summary.
2. Sample sized used for the test set and the data provenance
- Not Applicable: This pertains to clinical studies for AI/ML devices. For this orthopedic implant, the "test set" would typically refer to mechanical or bench testing. The document mentions "pre-clinical testing" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This relates to expert annotations for AI/ML models. For this device, "ground truth" would be established through engineering specifications, material standards (e.g., ASTM F 136 for Titanium Alloy), and results of mechanical testing. No expert panel for "ground truth" establishment as understood in AI/ML is described.
4. Adjudication method for the test set
- Not Applicable: This is relevant for expert disagreement resolution in AI/ML performance evaluation. Not mentioned for this orthopedic device.
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 specific to AI-assisted human performance studies. No such study was conducted or is relevant for a bone plate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI algorithm itself. Not relevant for a physical medical device.
7. The type of ground truth used
- Type of "Ground Truth": For this device, the "ground truth" is based on:
- Material Standards: ASTM F 136 (for Titanium Alloy) for biocompatibility and material properties.
- Engineering Specifications: Implicit in the design and manufacturing of the plate to meet the functional requirements for fixation.
- Pre-clinical Testing Results: Physical and mechanical testing to demonstrate performance equivalence.
8. The sample size for the training set
- Not Applicable: This is a concept for AI/ML model development.
9. How the ground truth for the training set was established
- Not Applicable: This is a concept for AI/ML model development.
In summary, the provided document is a 510(k) submission for a traditional medical device (bone plate) and does not contain the kind of information requested for an AI/ML-based 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.