(90 days)
The Proximal Humerus Fixtion System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The Skeletal Dynamics Proximal Humerus Fixation 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 fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus 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 document is a 510(k) K242436 FDA clearance letter for the Skeletal Dynamics Proximal Humerus Fixation System. It primarily focuses on demonstrating substantial equivalence to existing devices through performance testing, rather than reporting on a study with acceptance criteria and device performance as typically seen for AI/ML-based devices. Therefore, a direct response to some of the requested categories (like number of experts, adjudication method, MRMC study, training set details) will not be available in this document.
Here's the information extracted from the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Plates: Static and Dynamic testing per ASTM F382-17 | Established equivalency for the plates to predicate devices. |
| Screws: Driving Torque, Torsional Yield Strength, and Axial Pullout testing per ASTM F543-23 | Established equivalency for the screws to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a mechanical fixation system, not a software or AI/ML device that uses a "test set" of data in the common sense. The "testing" refers to mechanical performance testing of the hardware components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of expert consensus, is not relevant for the mechanical testing of this hardware device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used for evaluating human or AI interpretations of medical images or data, not for the mechanical testing of orthopedic implants.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document does not mention any MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a medical device (orthopedic implant), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance of this mechanical device is based on established engineering standards and measurements as defined by ASTM F382-17 for plates and ASTM F543-23 for screws. The comparison is made against the performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.
§ 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.