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The TE Gown is intended to provide the wearer an increased level of blood and other body fluid protection during certain surgical procedures that result in excessive blood exposures by providing total encapsulation.

The COOL-ZONE System is either a gown or hood that are similar to the Kappler Pro/Vent Surgical Gown which was the subject of Premarket Notification #K932694. The fabric in the COOL-20NE gown and hood is identical to the fabric in the Pro/Vent Surgical Gown. The Pro/Vent TE Gown and Hood are constructed from the same fabric as the predicate device. The design of the gown differs in that the gament provides totally encapsulated protection to the wearer. Total encapsulation means total coverage of the entire upper body, thus providing greater protection than conventional surgical apparel.. The TE Gown utilizes a mylar face shield for visibility. A zipper is located in the back of the garment. The TE Hood provides the same level of face and head protection, but does not extend down as far on the body. It will typically be worn with another surgical gown.

This document is a 510(k) Summary for a medical device (surgical gown/hood) and does not describe an AI/ML powered device. Therefore, most of the requested information regarding AI-specific evaluation criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only) performance," "sample size for the training set," or "adjudication method for the test set," is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device based on material composition, design, and non-clinical performance characteristics.

Here's an attempt to extract relevant information given the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device (Kappler Pro/Vent Surgical Gown). The device ("PRO/VENT TE") is considered to meet acceptance criteria if its characteristics are "identical" or equivalent to the predicate.

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

• Sample Size for Test Set: Not explicitly stated. The performance data is presented as generic characteristics of the material rather than results from a specific "test set" in the context of individual units. It's likely these are properties of the material itself.
• Data Provenance: Not specified. It represents the inherent properties of the material and product design as characterized by laboratory tests.

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

Not applicable. This is a physical product, and "ground truth" is established through standardized material testing, not expert consensus on interpretations.

4. Adjudication method for the test set

Not applicable. Material properties are measured objectively.

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/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used

The "ground truth" for the performance characteristics is derived from standardized material testing and laboratory measurements (e.g., ASTM or ISO standards for hydrostatic head, bacterial filtration, flammability, synthetic blood resistance) and sterilization validation protocols (e.g., overkill method for ETO sterilization and residue testing).

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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