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The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius and tibia.

The proposed product, Locking Compression Bone Plates and Screws System, contains (1) locking compression plates (LCPs) with various specifications, (2) locking screws with various specifications and (3) various specific instruments. The locking compression plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.

The provided text is a 510(k) Summary for a medical device (Locking Compression Bone Plates and Screws System). This type of submission focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of characteristics. It does not contain information about clinical studies with human participants, expert review, or AI algorithms.

Therefore, most of the requested information (regarding acceptance criteria for a study, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical data) is not present in the provided document. The device in question is a physical orthopedic implant, not an AI/software device.

However, I can extract information related to the acceptance criteria for the non-clinical tests and the device performance as reported in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are that the device 'complies' or 'meets' the requirements of the specified ASTM standards (ASTM F382-99 for metallic bone plates and ASTM F543-07 for metallic medical bone screws). The "reported device performance" indicates that the tests were conducted according to these standards and the device met all design specifications to demonstrate substantial equivalence to the predicate. The summary states: "The test results demonstrated that the proposed device complies with the following standards." and "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

Regarding the other requested information:

• 2. Sample sizes used for the test set and the data provenance: Not applicable. This document describes non-clinical, in-vitro mechanical testing of orthopedic implants, not a study involving human data or a "test set" in the context of an AI algorithm.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical testing is established by the defined parameters and methods within the ASTM standards.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical mechanical testing.
• 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 physical bone plate and screw system, not an AI diagnostic or assistance tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation is adherence to established mechanical testing standards (ASTM F382-99 and ASTM F543-07) for metallic bone plates and screws.
• 8. The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device mechanical testing.
• 9. How the ground truth for the training set was established: Not applicable.

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