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ComPel 1-Ply Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.

When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable through 125 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.

All the components used in these ComPel® Gowns are made from 100% Dacron polyester filaments. ComPel fabrics are dyed and treated with a fluorocarbon finish.

ComPel® Gowns will function as surgical attire when processed according to instructions through 125 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.

Here's an analysis of the provided information regarding the ComPel® 1-Ply Surgical Gowns, formatted to address your request:

Acceptance Criteria and Device Performance Study

The provided document describes the safety and effectiveness summary for ComPel® 1-Ply Surgical Gowns. This submission is for a medical device (surgical gowns) and the "device performance" refers to the gowns' physical properties and durability, rather than a diagnostic algorithm or AI. Therefore, concepts like "test set," "training set," "experts," and "ground truth" as they apply to AI/algorithm performance are not directly relevant in the context of this document. However, I can extract the acceptance criteria (standards/tests performed) and the reported device performance (successful completion of these tests).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided document for each specific test. However, the tests are applied to the "ComPel® 1-Ply Surgical Gowns" product. For durability, the claim is "through 125 complete cycles – wash, dry and sterilization," implying a sample of gowns was subjected to this number of cycles.
• Data Provenance: The document does not specify the country of origin where the tests were conducted. It is a submission by an American company (Standard Textile Company, Cincinnati, Ohio) to the U.S. FDA. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This is not applicable for this type of medical device submission. The "ground truth" is defined by the established standards and test methodologies (e.g., AATCC #127-1980, ASTM D-1682-75). The "experts" would be the accredited laboratories and technicians performing these standardized tests, who follow the documented procedures to determine if the product meets the specified criteria. Their qualifications are in conducting these specific material science and safety tests accurately.

4. Adjudication Method for the Test Set

• Not applicable in the context of product testing against material standards. The tests have defined pass/fail criteria, and results are typically determined by measurements and observations against those criteria, not by expert adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is relevant for diagnostic devices or AI algorithms where human readers' performance is compared with and without AI assistance. This document describes physical product performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This concept is not applicable. The device is a surgical gown, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is objectively defined by established engineering and material science standards and test methods. For example, a Suter Hydrostatic Test has a quantifiable pressure reading that determines barrier performance. Toxicity tests have specific indicators for cytotoxicity or irritation.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/algorithm. There is no concept of a "training set" for a physical product like a surgical gown.

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

• Not applicable. As there is no training set for a physical product, the method for establishing its "ground truth" is irrelevant in this context.

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