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Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications.

The gowns are provided sterile and non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile.

There are two types of surgical gown: Comfort Gown and Safewear Gown. And each type of surgical gown is available in five product sizes, including M, L, XL, XXL and XXXL.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Comfort Gown include Level 1 standard surgical gown which met the requirements for Level 1 classification, and Level 2 standard surgical gown which met the requirements for Level 2 classification. It is made of the same material and is classified as Level 1 and Level 2 standard surgical gowns based on marketing reasons.

Safewear gown include Level 3 standard surgical gown, Level 3 standard plus surgical gown, Level 3 reinforced surgical gown and Level 3 reinforced plus surgical gown, which all met the requirements for AAMI Level 3. The four Level 3 surgical gowns differ in the weight of non-woven and whether there are reinforcements, which is 45g/m² and 50g/m² for Level 3 standard surgical gown, 50g/m² for Level 3 standard plus surgical gown, 35g/m² for Level 3 reinforced surgical gown with 35g/m² PE breathable film reinforcement and 45g/m2 for Level 3 reinforced plus surgical gown with 35g/m² PE breathable film reinforcement.

The provided text is a 510(k) Summary for surgical gowns (Comfort Gown, Safewear Gown). It details non-clinical tests performed to demonstrate substantial equivalence to predicate devices.

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 sample sizes used for each specific non-clinical test. It lists the tests performed and their results for the different types of gowns (Comfort Gown and Safewear Gown, across various levels and styles).

The data provenance is non-clinical testing, performed by the manufacturer (Xuchang Zhengde Environstar Medical Products Co., Ltd.) to specific international and national standards (e.g., AATCC, ASTM, ISO, CFR). The country of origin of the data is implied to be China, given the manufacturer's address. The data is prospective in the sense that these tests were conducted specifically for the submission to demonstrate compliance.

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

This information is not applicable as the acceptance criteria are based on pre-defined objective performance standards (e.g., cm H2O for hydrostatic pressure, N for breaking strength, etc.), not expert consensus on qualitative data. The "ground truth" here is the pass/fail against these quantifiable benchmarks.

4. Adjudication Method for the Test Set:

This is not applicable as the tests are objective, quantitative measurements against established standards, not subjective assessments requiring adjudication.

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 is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

This is not applicable. The device is a physical product (surgical gown), not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on established standard specifications and quantifiable measurements (e.g., physical properties like strength, barrier performance, and biological safety evaluations). This is analogous to "bench testing" or "laboratory outcomes data" for medical devices, rather than expert consensus, pathology, or clinical outcomes data in the context of diagnostic algorithms.

8. The Sample Size for the Training Set:

This is not applicable. The context is non-clinical performance testing of a physical medical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as above.

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Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, SMS Standard Surgical Gown with Reinforcement met the requirements for Level 3 classification; BVB Surgical Gown and BVB Splicing Surgical Gown met the requirements for Level 4 classification.

Not Found

The provided document K192290 refers to the 510(k) premarket notification for surgical gowns. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing related to the physical properties of the device (such as barrier protection), rather than clinical studies involving detailed AI/algorithm performance metrics, expert adjudication, or reader studies as implied by your request.

Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant acceptance criteria and reported performance for the surgical gowns from the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on the ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The document specifies that the surgical gowns met the requirements for certain levels.

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

• Sample size for test set: Not explicitly stated in the provided document. The 510(k) summary would typically refer to compliance with standards like ANSI/AAMI PB70:2012, which includes specific testing methodologies and sample size requirements for evaluating barrier performance. However, the exact number tested by the manufacturer for this submission is not detailed here.
• Data provenance: The testing would have been conducted by the manufacturer, Xuchang Zhengde Environstar Medical Products Co., Ltd, or a contracted testing laboratory, to demonstrate compliance with the ANSI/AAMI standard. No information on country of origin of data or retrospective/prospective nature is given beyond the company's origin (China).

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

Not applicable. This device's performance is evaluated through physical and material property testing against a standard (ANSI/AAMI PB70:2012), not clinical interpretation by medical experts.

4. Adjudication method for the test set

Not applicable. This is not a study requiring expert adjudication of results. Performance is determined by standardized laboratory tests.

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/algorithm-based device and no MRMC study on human reader performance is relevant or was conducted for this submission.

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

Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used

The "ground truth" for this device's performance is defined by the standardized test methods and performance requirements outlined in ANSI/AAMI PB70:2012. This standard specifies how to measure liquid barrier performance (e.g., impact penetration and hydrostatic pressure tests for Level 3; viral penetration resistance for Level 4) and the criteria for classifying a gown into a specific level.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that utilizes a training set.

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

Not applicable. Refer to point 8.

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