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The Aero Blue Performance Surgical gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liquid Barrier classifications.

The Aero Blue Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone. The back of the gown has a Spundbond-Meltblown-Spunbond (SMS) fabric which allows for air-breathability with an AAMI Level 1 Liquid Barrier Performance Barrier.

The Aero Blue Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in the following various sizes: Small, Large, X-Large, XX-Large, XXX-Large, X-Long XL, X-Long XXL.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aero Blue Performance Surgical Gowns:

The provided documentation describes the acceptance criteria and performance of a medical device (Aero Blue Performance Surgical Gowns) for a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a full de novo study proving efficacy and safety from scratch. Therefore, the "study" referred to is primarily a series of performance tests against established standards and a comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Aero Blue Performance Surgical Gowns (K192362)

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

The document does not explicitly state the sample sizes for each specific test within the performance testing. However, given that these are performance tests for surgical gowns demonstrating compliance with industry standards (like AAMI PB70:2012 and various ISO/ASTM standards), the sample sizes would typically be determined by the requirements of those specific standards for each test (e.g., number of specimens for tensile strength, number of samples for barrier testing).

The data provenance is retrospective, as the tests were conducted on existing product designs to demonstrate substantial equivalence to a predicate device. The country of origin of the data is not specified, but the tests are based on internationally recognized standards (ISO, AAMI, ASTM, AATCC, CFR).

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

This type of submission (510(k) for surgical apparel) does not typically involve human expert adjudication of a test set in the way an AI diagnostic device would. The "ground truth" for these tests is established by:

• Industry standards and specifications: AAMI PB70:2012, ISO 9073-10, ASTM D5034, etc., define the criteria for what constitutes a "Pass" for each physical and material characteristic.
• Laboratory testing methodologies: Standardized laboratory procedures are followed to objectively measure the performance metrics (e.g., water resistance, tensile strength, biocompatibility).

Therefore, there isn't a stated number of experts or their qualifications for establishing a "ground truth" in the diagnostic sense, but rather adherence to established scientific and engineering principles and standards.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is about adherence to objective performance standards, not expert adjudication of diagnostic outcomes.

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

No. A MRMC comparative effectiveness study is designed to evaluate the impact of an AI system on human reader performance, typically in diagnostic imaging. This submission is for surgical gowns, which are physical barriers and do not involve diagnostic interpretation by human readers or AI.

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

No. This concept is not applicable to a physical medical device like a surgical gown. The "standalone performance" is essentially the physical performance of the gown itself against the specified criteria, which is what the non-clinical tests assess.

7. The Type of Ground Truth Used

The ground truth used for the assessment of the surgical gowns' performance is based on established industry standards and regulatory requirements. This includes:

• Performance Standards: Specific liquid barrier classifications (AAMI PB70:2012 Level 3 and Level 1), tensile strength, abrasion resistance, synthetic blood penetration, water vapor transmission, peel strength, linting, flammability, laser resistance.
• Biocompatibility Standards: ISO 10993 series for cytotoxicity, irritation, and sensitization.
• Sterilization Standards: ISO 10993-7 for Ethylene Oxide residuals.

These standards define the objective criteria that the device must meet to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set

Not applicable. Surgical gowns are physical products, not AI algorithms that require training data. The "training set" concept is irrelevant here.

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

Not applicable, as there is no training set for a physical device like a surgical gown.

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The Aero Blue* Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Blue* Performance Surgical Gowns meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications. The Aero Blue* Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

A Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 3 liquid barrier protection in the critical zone of the gown. The back of the gown is a SMS (spunbond/meltblown/spunbond fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection.

Acceptance Criteria and Device Performance Study for Aero Blue* Performance Surgical Gowns

This document outlines the acceptance criteria and the study that demonstrates the Aero Blue* Performance Surgical Gowns meet these criteria, based on the provided 510(k) summary (K140539).

1. Acceptance Criteria and Reported Device Performance

The Aero Blue* Performance Surgical Gowns are designed to meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications in the critical zone, and Level 1 in the non-critical back zone. The non-clinical testing performed demonstrated compliance with these and other relevant standards.

Note: The document explicitly states "All results of testing met acceptance criteria." This implies that the device performed within the established limits for each test.

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

The 510(k) summary does not specify the exact sample sizes used for each individual non-clinical test. It lists the standards and test methods applied. For instance, for liquid barrier and blood penetration, it refers to standards like AAMI PB70:2012 and ASTM F-1670-08. These standards typically define minimum sample sizes for testing to ensure statistical validity.

The data provenance is retrospective, as the tests were conducted on the manufactured Aero Blue* Performance Surgical Gowns to demonstrate compliance with established standards. The country of origin of the data is not explicitly stated but is implicitly from the manufacturer's testing facilities or accredited third-party labs where these standards are tested, likely within the US given the submission to the FDA.

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

This section is not applicable for this medical device. The "ground truth" for the performance of a surgical gown is established by objective, standardized test methods and criteria defined by recognized national and international standards organizations (e.g., AAMI, ASTM, ISO, CPSC). These standards specify the methodology, equipment, and acceptable limits for performance. There is no human expert "ground truth" to be established in the context of device performance testing for surgical gowns.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where expert consensus is needed to establish ground truth. As noted above, the performance of a surgical gown is evaluated against predefined objective criteria and standardized test results. Therefore, no human adjudication method was employed or is relevant for this type of device testing.

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

An MRMC study is not applicable and was not done. This type of study assesses the impact of a device (often an AI algorithm) on human reader performance, typically in diagnostic imaging. The Aero Blue* Performance Surgical Gowns are barrier garments, not diagnostic tools, and do not involve human "readers" or AI assistance in their function.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study of an algorithm is not applicable and was not done. The Aero Blue* Performance Surgical Gown is a physical medical device, not an algorithm or software. Its performance is evaluated directly through physical and material property tests.

7. The Type of Ground Truth Used

The ground truth used for the device's performance claims is based on objective, quantitative measurements and qualitative assessments derived from recognized industry standards and test methods. Specifically:

• Standardized Test Data: The "Pass" results in the "Summary of Non-Clinical Testing" indicate that the device met the precise, objective criteria set forth by each referenced standard (e.g., AAMI PB70:2012 for liquid barrier, ASTM-1670-08 for synthetic blood penetration, ISO 10993 for biocompatibility).
• Performance Metrics: The "ground truth" is defined by specific physical and material properties (e.g., water resistance, tensile strength, flammability, cytotoxicity) measured against predefined thresholds in the standards.

8. Sample Size for the Training Set

A "training set" is not applicable to this device. Training sets are used in the development of machine learning algorithms. The Aero Blue* Performance Surgical Gowns are physical products whose performance is determined by their material composition, design, and manufacturing processes, and subsequently validated through non-clinical laboratory testing.

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

This question is not applicable as there is no training set for this device. The physical and chemical properties of the materials, and thus the performance characteristics of the gown, are established through material science, engineering, and validated test methods, not through an iterative process of training an algorithm on a dataset with established ground truth.

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