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BARRIER® surgical gowns are intended for single use to be worn by the Surgical Team Members in the operating room during surgical procedures to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

The BARRIER® Surgical Gowns have been designed with an assortment of fabrics and have been on the market for a number of years cleared under predicate 510(k) notifications. BARRIER surgical gowns have been developed for general surgical procedures and for procedures which represent possible exposure to bloodborne pathogens and other potentially infectious materials which require increased levels of protection.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "BARRIER® Surgical Gowns have been evaluated using the ANSI/AAMI PB-70:2003 Standard. (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities)."

• Sample Size for Test Set: The exact sample size for each gown type is not explicitly stated in the provided 510(k) summary. The AAMI PB-70:2003 standard likely specifies the minimum sample size required for testing.
• Data Provenance: The document does not provide details on the country of origin of the data or whether the study was retrospective or prospective. It only mentions the standard used for evaluation.

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

This information is not applicable to this type of device (surgical gowns) and the testing performed. The "ground truth" here is objective physical testing against a recognized standard (ANSI/AAMI PB-70:2003) for liquid barrier performance, not subjective human assessment.

4. Adjudication Method for the Test Set:

This information is not applicable. As stated above, the evaluation is based on objective physical testing according to a published standard, not on human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with and without AI assistance. Surgical gowns are protective apparel, and their performance is assessed through laboratory testing against industry standards.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. There is no "algorithm" or AI component to the BARRIER® Surgical Gowns. Their performance is inherent to their material and construction, measured through physical tests.

7. The Type of Ground Truth Used:

The ground truth used is the objective measurements of liquid barrier performance as defined and specified by the ANSI/AAMI PB-70:2003 Standard. This standard outlines the specific test methods and criteria to classify protective apparel based on its barrier performance against liquids.

8. The Sample Size for the Training Set:

This question is not applicable. Since there is no AI or machine learning component, there is no "training set." The performance of the surgical gowns is determined through physical testing of manufactured samples.

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

This question is not applicable for the same reason as point 8.

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A BARRIER surgical gown is a single use article of surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The new BARRIER surgical gowns have high repellency areas ( front and lower sleeves) constructed from new breathable repellent materials.

This document describes the acceptance criteria and the study conducted for the new BARRIER surgical gowns.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each material test. It mentions that the "new materials were tested versus the predicate materials in the applicable standard material evaluations."

• Test Set Sample Size: Not specified.
• Data Provenance: The document implies that the testing was performed internally by the manufacturer (Johnson & Johnson Medical) or by third-party labs on behalf of the manufacturer, following established industry standards. The country of origin of the data is not specified, but the submission is to the US FDA, suggesting the data would comply with US regulatory standards. The testing is for a new product undergoing premarket notification, implying prospective testing for this specific device.

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

This document describes performance testing of a physical product (surgical gowns) based on established material science standards. The "ground truth" is determined by objective measurements and compliance with these standards, not by expert interpretation in a clinical context. Therefore, the concept of "experts establishing ground truth" as it applies to medical imaging or diagnostics is not directly relevant here. The experts involved would be material scientists, engineers, and technicians conducting the specified tests and interpreting results according to the standards. No specific number or qualifications of these testing personnel are provided.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective material performance tests, where results are measured against defined criteria within the standard. There is no subjective interpretation or adjudication process as would be seen in clinical or diagnostic studies.

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

Not applicable. This is a submission for a physical medical device (surgical gown) based on material performance, not a diagnostic or AI-assisted device that would involve human readers.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Performance Testing Summary" section describes the results of the new materials and gowns being tested against various standards (Class I flammability, ASTM 1671, ISO 10993-1) and compared to the predicate device for breathability, strength, and repellency. This represents the performance of the device itself (the surgical gown) without human interaction in a diagnostic or interpretive capacity.

7. Type of Ground Truth Used

The ground truth used is based on:

• Objective Material Performance Standards: Compliance with recognized international and national standards (e.g., ISO 10993-1, 16CFR1610 Class I flammability, ASTM Standard Test Method 1671).
• Direct Comparison to Predicate Device Performance: The new materials were compared to predicate materials for properties like breathability, strength, and repellency, where the predicate's established performance serves as a comparative benchmark.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The performance is based on the physical properties of the materials and production processes.

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

Not applicable, as there is no training set for this type of device.

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