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The intended use of this device is to support a patient during radiation therapy; or The intended use of the MED-TEC 6 degree axis couch is to support and aid in positioning a patient during radiologic, radiation therapy, and other medical procedures.

The 6 degree axis couch adds Pitch and Roll to the normal X, Y, Z. and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table.

MED-TEC 6 degree axis couch

The provided document is a 510(k) cleared by the FDA for the "MED-TEC 6 degree axis couch." This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner you've outlined for performance studies.

Therefore, most of the information you've requested regarding acceptance criteria, a specific study proving those criteria, sample sizes, expert involvement, and ground truth types is not available within this 510(k clearance letter and its attached "Indications For Use" statement.

The 510(k) process for a Class II device like this couch generally involves submitting information about the device's design, intended use, materials, manufacturing processes, and how it compares to a legally marketed predicate device. The "acceptance criteria" here are typically tied to the device's ability to perform its intended function safely and effectively, similar to the predicate, and to comply with general controls and any special controls applicable to its device class.

Here's what can be inferred or stated based on the provided text, and where your requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics within this document. The implicit acceptance criteria are that the device performs its intended function (patient support and positioning during radiation therapy and other medical procedures) safely and effectively, and is substantially equivalent to a predicate device. This would typically involve demonstrating mechanical stability, range of motion, load bearing capacity, and safety features in testing, but these specific criteria and their target values are not detailed here.
• Reported Device Performance: The document states the device "supports and aids in positioning a patient during radiologic, radiation therapy, and other medical procedures" and that the "6 degree axis couch adds Pitch and Roll to the normal X, Y, Z, and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table." This describes the functionality and benefit of the device but doesn't provide quantitative performance data against specific acceptance criteria.

2. Sample size used for the test set and the data provenance

• Not available. The document does not describe a clinical or performance "test set" in the context of, for example, image analysis or diagnostic accuracy. For a device like a patient support assembly, testing would likely involve engineering and bench testing rather than human subject testing in the traditional sense of a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not available. There is no mention of "experts" establishing "ground truth" for a test set in this 510(k documentation, as it's not a study involving expert assessment of data (e.g., medical images).

4. Adjudication method for the test set

• Not applicable/Not available. No test set or adjudication method is 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 device is a mechanical patient support assembly, not an AI-driven diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a mechanical patient support assembly and does not involve an algorithm with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable/Not available. Ground truth, in the context of the type of studies implied by your questions, is not relevant to this mechanical device's 510(k. The "truth" for this device would be its mechanical specifications, safety, and functionality conforming to engineering standards and its intended use.

8. The sample size for the training set

• Not applicable/Not available. There is no "training set" relevant for a mechanical device like this couch.

9. How the ground truth for the training set was established

• Not applicable/Not available. As there is no training set, this question is not applicable.

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