(94 days)
The Skeletal Dynamics Protean Fragment Plating System is intended for stabilization and fixation in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, clavicle, scapula, finger, toe, and pelvis, particularly in osteopenic bone with the appropriate configuration of the device. The system is intended for use in adult and pediatric populations (children and adolescents).
The Skeletal Dynamics Protean Fragment Plating System is a set of medical-grade Titanium Alloy (Ti-6Al-4V ELI) bone plates and Titanium and Cobalt Chrome (CoCr) screws and pegs designed for the stabilization and repair of small bone fragments in conjunction with general and specialized instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.
This is a 510(k) premarket notification for a medical device called the Protean Fragment Plating System. This document does not describe a study involving AI or human readers for device performance evaluation. The "Performance Testing" section states that engineering analysis and mechanical testing were performed, but these are bench tests for the physical properties of the plates and screws (e.g., strength, torque), not a study comparing the diagnostic performance of the device or human readers with and without AI.
Therefore, I cannot provide information on acceptance criteria and study details related to AI performance or human reader studies.
Here's a summary of what is provided regarding performance testing, although it does not directly answer the questions about AI/human reader studies:
1. A table of acceptance criteria and the reported device performance:
The document mentions that bench testing was performed according to ASTM standards to establish equivalency with predicate devices regarding mechanical properties. It does not provide specific acceptance criteria values or a direct side-by-side comparison table of "reported device performance" in the way one might expect for a diagnostic AI study. Instead, it makes a general statement of equivalency.
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Plates (Static and Dynamic Testing) | Equivalence established to predicate devices per ASTM F382-17. |
| Screws (Driving Torque, Torsional Yield Strength, Axial Pullout) | Safety and effectiveness established per ASTM 543-23 and guidance "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway". |
Regarding the other points in your request, the document does not contain the following information as it pertains to AI/human reader studies:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.