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The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.

The CLINI-DYNE Rotational Therapy System consists of an electromechanical inflation pump control unit which is connected to a mattress with cells (air filled bladders) through hose assemblies connected to the inflation pump. The system affords programmed patient position changes by gently turning the patient from supine to left side or right side and back to supine position when staff is unable to do so or needs assistance.

The provided text describes a Premarket Notification [510(K)] Summary for the GAYMAR INDUSTRIES, INC. CLINI-DYNE Rotational Therapy System. This document focuses on demonstrating substantial equivalence to a predicate device (CLA 1400 System) rather than reporting on a study demonstrating the device meets pre-defined acceptance criteria in the way a clinical trial for a novel AI device would.

Therefore, the requested information elements related to AI device performance studies (like sample size for test sets, expert consensus, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document. This is a regulatory submission for a medical device that predates the common application of AI in medical imaging or diagnosis.

However, I can extract information related to the device's technical specifications and safety testing, which serve as a form of "acceptance criteria" for demonstrating substantial equivalence.

Here's the information that can be extracted from the provided text, adapted to the requested format where possible:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of 510(k) submission, "acceptance criteria" are typically defined by demonstrating that the new device is as safe and effective as the predicate device. The performance is compared feature-by-feature for substantial equivalence.

NOTE 1: The document notes "See Substantial Equivalence" for these differences, implying that despite the direct difference, the total package of features and safety data still allows for a claim of substantial equivalence for the intended use.

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

• Not Applicable. This document describes a Traditional 510(k) for a physical medical device (Rotational Therapy System). The "test set" and "data provenance" as understood in AI/ML performance studies (e.g., patient data, image sets) are not relevant here. The "testing" involved physical and electrical safety standards (e.g., biocompatibility on materials, flammability, UL standards).

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

• Not Applicable. Ground truth in the context of expert consensus on data interpretation is not relevant for this device's regulatory submission. Safety and performance were assessed against established technical standards and by comparison to a predicate device.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple experts interpreting data, which is not applicable to the type of testing described here.

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. MRMC studies are used for evaluating diagnostic performance, often in conjunction with AI. This document is for a physical patient support system.

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

• For Biocompatibility, Tissue Interface Testing, and Flammability: The "ground truth" was established by standardized laboratory testing procedures against pass/fail criteria for physical and chemical properties.
• For UL Approvals: "Ground truth" is compliance with Underwriters Laboratories (UL) standards.
• For comparative features: "Ground truth" is the demonstrated performance and characteristics of the predicate device (CLA-1400).

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not Applicable. This device does not involve a "training set."

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