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The AERO CHROME* Breathable Performance Surgical Gowns are 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 CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.

The AERO CHROME* Breathable Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown- Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 4 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 CHROME* Breathable 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.

This document is a 510(k) Premarket Notification for the AERO CHROME* Breathable Performance Surgical Gowns, seeking substantial equivalence to a predicate device (K153255). It is not a study proving device meets acceptance criteria in the context of an AI/ML medical device. Therefore, it does not contain the information required to answer the requested questions regarding acceptance criteria, study design, sample sizes, expert involvement, or training data for an AI/ML device.

This document describes the physical and performance characteristics of a surgical gown and compares it to a previously cleared predicate device to demonstrate substantial equivalence for regulatory purposes. The "acceptance criteria" referred to in the document are the performance standards (e.g., AAMI PB70:2012 liquid barrier classifications, ISO standards for biocompatibility, flammability) that the surgical gown must meet. The "study" proving device meets acceptance criteria refers to the non-clinical testing performed on the gowns to ensure they comply with these standards.

Here's an attempt to answer the questions based on the provided document, understanding that the questions are framed for AI/ML devices and this document is for a physical medical device (surgical gown):

Acceptance Criteria and Device Performance (for a physical medical device - surgical gown)

The document primarily focuses on demonstrating that the subject device (AERO CHROME* Breathable Performance Surgical Gowns) is substantially equivalent to a predicate device (K153255) by meeting the same regulatory and performance standards. The "acceptance criteria" here are established industry standards and regulatory requirements for surgical gowns. The "reported device performance" is a statement of compliance with these standards based on non-clinical testing.

1. A table of acceptance criteria and the reported device performance

Based on the "Technological Characteristic Comparison Table" and "Summary of Non-Clinical Testing" sections:

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

The document does not specify the exact sample sizes used for each material or performance test. It states "non-clinical tests" were conducted. The data provenance is industrial testing of material and product performance, typically conducted in a laboratory setting by the manufacturer or a third-party testing facility. This is a prospective testing regimen to ensure product quality and regulatory compliance. Country of origin for data is not specified but would be the location of the testing laboratories.

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

This question is not applicable to this type of device. "Ground truth" in this context is established by standardized test methods (e.g., AATCC, ASTM, ISO standards) and the results obtained from calibrated scientific instruments. There are no human "experts" establishing ground truth in the sense of medical diagnosis or image annotation for this product testing. The "experts" involved would be qualified laboratory technicians and engineers proficient in performing the specified material and performance tests.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML or diagnostic study requiring adjudication of expert opinions. Results are binary (Pass/Fail) based on meeting pre-defined thresholds in the specified standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is a physical medical device (surgical gown), not a diagnostic tool or AI/ML system, so MRMC studies are not relevant. This document is a comparison of the subject device to a predicate device based on material composition and physical performance, not a comparative effectiveness study involving human readers.

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

Not applicable. This is not an algorithm. The "standalone" performance here refers to the gown's intrinsic physical and barrier properties as measured in the laboratory tests.

7. The type of ground truth used

The "ground truth" for this device is based on standardized physical and chemical test results against established performance specifications (e.g., AAMI PB70, ISO 10993, ASTM standards). It is not expert consensus, pathology, or outcomes data in the medical context of AI/ML.

8. The sample size for the training set

Not applicable. Surgical gowns are not "trained" like AI models. The document describes the "construction overview" and materials used, which are the product's design specifications. There isn't a "training set" in the computational sense.

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

Not applicable. As there is no "training set," there is no "ground truth" to establish for it in this context. The manufacturing process and material specifications for the gown are derived from engineering design, material science data, and compliance with the relevant industry standards.

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The Aero Chrome* Breathable 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 Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.

The Aero Chrome* Breathable 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

The Aero Chrome* Breathable Performance Surgical Gowns have a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.

The provided document is a 510(k) premarket notification for a medical device: the Aero Chrome Breathable Performance Surgical Gown*. This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving novel efficacy or safety through primary clinical trials for the device itself. Therefore, the "study" proving the device meets acceptance criteria primarily consists of non-clinical performance testing to show that the new device performs at least as well as, or equivalently to, the predicate device in relevant aspects.

Here's an analysis of the acceptance criteria and the provided information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a single consolidated "acceptance criteria" table as one might find for a diagnostic AI device with precision/recall metrics. Instead, it details various performance tests demonstrating compliance with recognized standards for surgical gowns. The acceptance criteria for each test are implicitly (or explicitly, as "Pass") stated as meeting the requirements of the specified standard.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. Standard test methods (e.g., ASTM, ISO, AAMI) typically define the minimum sample sizes required for statistically valid testing. For example, for textile testing (tensile strength, abrasion), there would be a specified number of specimens. For biocompatibility (cytotoxicity, irritation, sensitization), there would be a defined number of replicates and control groups.
• Data Provenance: The data comes from the manufacturer's (Halyard Health, Inc.) own non-clinical performance testing. It is not explicitly stated if these were internal labs or third-party labs, but generally, such tests are conducted in controlled lab environments. The document does not specify a country of origin for the data; it's implicit to be associated with Halyard Health's operations for regulatory submission in the US.
• Retrospective or Prospective: These are prospective tests performed specifically to demonstrate that the newly designed Aero Chrome* gown meets the required performance standards for its intended use and for comparison with the predicate device.

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

• This question is not applicable in the context of this device and submission. This is a surgical gown, not an AI/diagnostic device that relies on expert interpretation of images or patient data to establish ground truth. The "ground truth" for a surgical gown's performance is established by objective, measurable physical, chemical, and biological properties, as defined by recognized consensus standards (e.g., AAMI, ISO, ASTM). The expertise lies in conducting the tests according to the standard protocols and interpreting the quantitative results against the specified pass/fail criteria.

4. Adjudication method for the test set:

• This question is not applicable. Since the "ground truth" is established through objective laboratory testing against predefined standards (e.g., a specific resistance value, a pass/fail for bacterial penetration), there is no human "adjudication" in the sense of multiple readers or experts reviewing subjective data. The test results are quantitative/qualitative outcomes of physical/chemical processes.

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:

• This question is not applicable. This is a physical medical device (surgical gown), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

• This question is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The ground truth for this device's performance is established by objective, quantitative measurements and qualitative assessments derived from standardized laboratory test methods (e.g., AAMI PB70:2012, ASTM D5034, ISO 10993 series). These standards define specific criteria (e.g., pressure resistance, microbial penetration, tensile strength limits, cytotoxicity levels) that the device must meet. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic tool would be.

8. The sample size for the training set:

• This question is not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The manufacturing process of surgical gowns involves material selection, design, and fabrication, which are validated through process controls and quality assurance, not through a "training set" of data.

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

• This question is not applicable for the reasons stated above.

In summary: The submission for the Aero Chrome* Breathable Performance Surgical Gown focuses on demonstrating substantial equivalence to a predicate device (Aero Blue* Performance Surgical Gown) by providing comprehensive non-clinical performance test results against established industry standards. The "acceptance criteria" are the "Pass" outcomes for each of these standardized tests, indicating that the gown meets the specified physical, chemical, and biological performance requirements relevant to its intended use as protective apparel. The evaluation does not involve clinical studies with human "readers" or AI algorithms.

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