(27 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 wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.
The Acumed Total Wrist Fusion Plating System contains plates which are pre-contoured with an anatomic design. The plates have a combination of distal and proximal holes which utilize 2.3 mm and 3.5 mm cortical locking screws and non-locking screws. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the previously cleared Acumed Wrist Arthrodesis Plate System including modifications to existing plates, the addition of the Neutral plate and the modified 2.3 mm screw.
The Acumed Wrist Arthrodesis Plate System is a medical device, and its regulatory clearance process, as described in the provided 510(k) summary, does not involve the types of acceptance criteria and studies typically associated with AI/ML-driven devices. Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, training set size, and how training ground truth was established) are not applicable to this submission.
Instead, the acceptance criteria and study for this device are based on demonstrating substantial equivalence to previously cleared predicate devices through engineering rationales and bench testing.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Equivalence | Components manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136. | Acumed Total Wrist Fusion Plating System components are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136. |
| Technological Equivalence | No technological characteristics that raise new issues of safety or effectiveness compared to predicate devices. | The plates and screws are made of titanium alloy (Ti-6Al-4V) per ASTM F136. The predicate devices share these dimensional and material characteristics. No technological characteristics that raise new issues of safety or effectiveness. |
| Mechanical Performance (Rationales) | Engineering rationales (e.g., calculations of moments of inertia and cross-sectional area) to prove substantial equivalence to predicate plates and screws. | Engineering rationales, including calculations of moments of inertia and cross-sectional area, were conducted. These proved that the subject plates and screws are substantially equivalent to the predicate plates and screws. |
| Mechanical Performance (Bench Testing) | Distal screw construct pull-out strength demonstrating substantial equivalence to the distal predicate screw-plate construct. | Distal screw construct pull-out bench testing was performed. This proved that the distal subject screw-plate construct is substantially equivalent to the distal predicate screw-plate construct. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of medical device submission. The evaluation was primarily based on engineering rationales and bench testing of physical components, not on a "test set" of clinical data or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for AI/ML models is not relevant to this submission. The "ground truth" here is the established safety and effectiveness of the predicate devices and the physical properties and performance characteristics of the materials and designs.
4. Adjudication method for the test set
Not applicable. No "test set" in the context of AI/ML models was used.
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
Not applicable. This device is a bone fixation system, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone fixation system, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" or basis for comparison used in this submission is the established safety and effectiveness of the legally marketed predicate devices, combined with adherence to recognized material standards (ASTM F136) and biomechanical principles verified through engineering rationales and bench testing.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth was established for this 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.