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The OlecraNail® Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

The OlecraNail® intramedullary nail is a fixation device that has been previously cleared for marketing (K090091). Accessories are being added to the system that will offer optional advantages in terms of how the procedure is accomplished, specifically how the bone is cut, the drill holes are measured, and how the nail is removed.

The provided text describes a Special 510(k) application for accessories to an already cleared device, the OlecraNail® Intramedullary Fixation System. The focus of the submission is on demonstrating the substantial equivalence of the new accessories to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not explicitly stated. The text mentions "human cadaveric testing," but does not provide the number of cadavers or specimens used.
• Data Provenance: The origin of the cadavers (e.g., country) is not specified. The testing was likely conducted in a controlled environment as part of the regulatory submission process. It is a prospective study in the sense that the testing was conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not provided in the text. Human cadaveric testing implies the involvement of experts for setup, performance, and evaluation, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the text. For mechanical or functional testing like cadaveric studies, adjudication methods similar to those for clinical trials (e.g., 2+1, 3+1) are not typically applicable. The evaluation would likely involve objective measurements and expert assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was a MRMC study done? No.
• The device is a physical fixation system (intramedullary nail and accessories), not an imaging or diagnostic AI device. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance is not relevant or applicable to this type of medical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, in a sense.
• The "human cadaveric testing" can be considered a standalone performance evaluation of the device accessories' design and function. This testing evaluates the device's physical performance independent of an "AI algorithm" or human interpretation of data generated by the device in a clinical setting (since it's a surgical implant). The "standalone" here refers to the device's functional integrity as a physical product.

7. Type of Ground Truth Used

The ground truth for the cadaveric testing would be based on direct observation and objective measurements of the mechanical performance and functional integrity of the OlecraNail® accessories during surgical simulation or testing on human cadavers. This would include assessing proper bone cutting, accurate drill hole measurement, and effectiveness of nail removal, as implied by the stated purpose of the accessories. It is essentially an engineering-based ground truth related to mechanical performance and surgical technique.

8. Sample Size for the Training Set

This information is not applicable. The device is a surgical implant system, not a machine learning model that requires a "training set" of data. The development of the device's design would be based on engineering principles, predicate device designs, and expert surgical knowledge, rather than a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set in the context of this device. The design and validation relied on established engineering standards, biomechanical principles, and comparison to legally marketed predicate devices.

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