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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

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:

2. 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.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process described.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. 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.
8. The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
9. 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)

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Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.

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The provided document is a 510(k) summary for the Stryker® Leibinger Universal Distal Radius System, a medical device for internal fixation of small bone fractures. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria for device performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Such studies, often involving clinical trials or performance testing with defined endpoints and statistical analyses, are typically submitted as part of the 510(k) application itself but are usually not detailed in the publicly available 510(k) summary.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document primarily states the device's intended use and declares its substantial equivalence to predicate devices (K981283, K961496, and K014263). The substantial equivalence determination by the FDA implies that the new device is as safe and effective as a legally marketed device and does not require explicit proof of performance against new, separate acceptance criteria in the summary.

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