(59 days)
The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in both left and right Humerus. The plate segment of the Shoulder Nail Plate is intended to be attached to the metaphysis of the humerus. The nail segment of the Shoulder Nail Plate is intended to be inserted into the humeral diaphysis for optimal stabilization of the fracture.
The provided text is a 510(k) summary for a medical device called the "Shoulder Nail Plate." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical study report detailing acceptance criteria for performance verification with data.
Therefore, many of the requested elements about acceptance criteria, device performance metrics, study design, and ground truth establishment are not applicable. The document focuses on demonstrating equivalence to predicate devices through intended use, materials, biocompatibility, and overall performance characteristics, and not on establishing specific performance metrics against a set of acceptance criteria in a clinical or analytical study.
Here's an assessment based on the available information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary states, "The Shoulder Nail Plate is substantially equivalent to the predicate Shoulder Side Plate of the Shoulder Fixation System with regards to the intended use, materials, biocompatibility, and overall performance characteristics. The equivalence was confirmed through pre-clinical testing." This indicates that performance was assessed relative to the predicate, but specific acceptance criteria and detailed quantitative performance data are not included in this summary.
2. Sample size 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 document mentions "pre-clinical testing" but does not detail the nature of these tests, 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 (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The device is a bone fixation plate, not an AI or diagnostic device that requires expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed for this 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
This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretation devices, which this is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of typical "ground truth" as described for diagnostic or AI devices. The substantial equivalence relies on demonstrating similar physical and mechanical properties, biocompatibility, and intended use as predicate devices. The "ground truth" for non-AI medical devices generally refers to established scientific principles, consensus standards regarding material properties, and clinical outcomes for predicate devices. The document states biocompatibility was based on meeting ASTM F 138-03, which serves as a standard for stainless steel, indicating compliance with a recognized material standard.
8. The sample size for the training set
This information is not applicable/not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
In summary:
The provided document is a 510(k) summary, which is a regulatory submission focused on demonstrating substantial equivalence to existing legally marketed devices. It does not contain details of a clinical or analytical study with defined acceptance criteria and performance metrics in the way these questions are framed for, for example, diagnostic or AI devices. The "study" mentioned is "pre-clinical testing" to confirm equivalence, but no specific data or methodology from this testing is provided in this summary.
§ 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.