(91 days)
The Universal Distal Radius System is intended for the fixation of intra and extraarticular fractures as well as distal radius osteotomy.
The Universal Distal Radius System consists of a range of plates and screws for distal radius surgery. Each device is manufactured from titanium and can be color anodized. The Universal Distal Radius System will be provided non-sterile for steam sterilization by health care professional's prior use, or provided sterile by gamma sterilization.
The provided 510(k) summary for the Universal Distal Radius System (K130774) describes a medical device, not an AI/ML powered device, therefore the information requested is not directly applicable.
However, I can extract information related to the device's performance based on the provided text, focusing on the non-clinical testing performed to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Equivalence to predicate devices in: | Met, through comparative compression and flexion testing. The device is "substantially equivalent to the predicate devices in terms of indications for use, design, material, and function." |
| - Compression strength | Demonstrated equivalence to predicate devices. |
| - Flexion strength | Demonstrated equivalence to predicate devices. |
Explanation of "Implied" Acceptance Criteria:
For a 510(k) submission, especially for a Special 510(k) indicating minor changes from a predicate, the "acceptance criteria" are typically demonstrating substantial equivalence to the legally marketed predicate devices. This means showing that the new device performs at least as well as, and not worse than, the predicate devices in relevant performance metrics. Here, mechanical testing (compression and flexion) was used to demonstrate this.
Regarding the other requested information (focused on AI/ML studies):
Since the Universal Distal Radius System is a physical medical device (plates and screws for fracture fixation) and not an AI/ML powered device, the following points are not applicable and no information is provided in the document for them:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical or data-driven test set mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No human expert assessment for ground truth mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process described.
- 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 is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth, in the context of AI/ML, is not relevant here.
- The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
- How the ground truth for the training set was established: Not applicable. No training set for an AI/ML model is mentioned.
Summary of the Study performed (Non-clinical):
The study performed was a non-clinical comparative mechanical testing study.
- Test Performed: Comparative compression and flexion tests on plates.
- Purpose: To demonstrate that the Universal Distal Radius System is substantially equivalent to predicate devices in terms of mechanical safety and performance.
- Outcome: The tests supported the conclusion of substantial equivalence to predicate devices in terms of design, material, and function.
- Clinical Studies: "No clinical studies were performed." (Section 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.