(288 days)
The MDS Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.
The Proximal Humerus Plating System is an internal fixation plate system to be used for proximal humerus fractures. The system consists of plates, screws, and locking caps. The Proximal Humerus Plates are available in two lengths, and are side-specific. The Proximal Humerus Plating System Screws are 3.5mm in diameter and available in various lengths.
This document describes a 510(k) premarket notification for the "Proximal Humerus Plating System," a metallic bone fixation device. The submission primarily relies on non-clinical performance testing to establish substantial equivalence, common for Class II devices of this nature.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Conclusion) |
|---|---|
| ASTM F382-99: Standard Test Method for Metallic Medical Bone Plates | The Proximal Humerus Plating System performs as well as the predicate devices. |
| ASTM F543-07: Standard Specification and Test Method for Metallic Bone Screws | The Proximal Humerus Plating System performs as well as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (number of plates/screws tested) for mechanical testing. It mentions "non-clinical (laboratory/performance) testing." The data provenance is laboratory testing, not from human subjects or patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for this device is based on compliance with engineering standards (ASTM F382-99 and ASTM F543-07) and mechanical testing data, not expert human interpretation of medical images or conditions.
4. Adjudication Method for the Test Set:
Not applicable. There was no human expert adjudication involved in establishing the "ground truth" for the mechanical performance of this device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The device is a surgical implant, and its effectiveness is determined by its mechanical properties and surgical outcomes, not by reader performance in interpreting imaging data.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done:
Not applicable. This device is a physical medical implant, not an algorithm or AI-powered system, so the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used:
The ground truth used is based on engineering standards and mechanical testing data. Specifically, the device's performance was compared against the requirements and methodologies outlined in ASTM F382-99 for bone plates and ASTM F543-07 for bone screws.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical implant; therefore, it does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.