(264 days)
The Acumed Wrist Arthrodesis Plate System is intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis r frame wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, turnor resection, and spastic deformities.
Device Book prist Arthrodesis Plates are pre-contoured with an anatomic design with multiple rric Acaned Which will be a combination of distal and proximal holes which utilize 2.3 mm and 3.5 mm cortical locking and non-locking screws.
This document describes a 510(k) submission for the Acumed Wrist Arthrodesis Plate System. As a medical device that makes physical claims (e.g., bone fixation, strength), the evaluation relies on engineering and mechanical testing rather than AI/software performance. Therefore, many of the requested categories related to AI/software performance, ground truth, and expert evaluation are not applicable.
Here's the information derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate comparison) | Reported Device Performance (Acumed Wrist Arthrodesis Plate System) |
|---|---|
| Withstand equivalent or greater load before plastic deformation as predicate device | Able to withstand more load than the predicate device before plastic deformation (based on engineering analysis). |
| Require equivalent or greater force for distal screw pull-out as predicate device | Required equivalent force for distal screw pull-out as the predicate device (based on mechanical testing). |
| Require equivalent or greater energy for distal screw pull-out as predicate device | Required significantly more energy for distal screw pull-out than the predicate device (based on mechanical testing). |
| Material composition equivalent to predicate devices | Plates and screws are made of titanium alloy, Ti 6Al 4V, per ASTM F136, which is stated to be shared with predicate devices. |
| Dimensional characteristics equivalent to predicate devices | Predicate devices share dimensional characteristics. The Acumed plates are pre-contoured with an anatomic design with multiple holes (2.3 mm and 3.5 mm cortical locking and non-locking screws). No specific dimensional comparison data is provided beyond this general statement. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of an engineering analysis and mechanical testing on physical devices.
- For the engineering analysis of plate strength, calculations were performed, likely on designs or theoretical models.
- For mechanical testing of distal screw pull-out strength, an unspecified number of physical plates and screws were tested.
- Data Provenance: Not applicable in the traditional sense of human subject data. The testing was conducted internally by Acumed, LLC, on their manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. The "ground truth" for this type of device (bone fixation plate) is established through standardized engineering analyses and mechanical testing protocols, not through expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is relevant for AI-powered diagnostic or screening devices and is not applicable to a bone fixation plate.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
- Engineering analysis principles and mechanical testing standards. The "ground truth" for performance claims is based on established scientific principles of material strength and mechanical properties, measured against validated testing methodologies. The predicate devices serve as the benchmark for "substantially equivalent" performance.
8. Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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.