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The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).

The Surgical Isolation Gown has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3 requirement.

The provided text describes the acceptance criteria and performance of the "Surgical Isolation Gown" (K212357) by Wuhan Zonsen Medical Products Co., Ltd. This is a non-clinical study, as stated in section I. Clinical Performance.

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

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

The sample size used for the performance tests (Flammability, Hydrostatic Pressure, Impact Penetration, Tensile Strength, Tearing Strength, Seam Strength, Linting, Evaporative Resistance) was 3 non-consecutive lots, with 32 samples per lot for average results.
The data provenance is not explicitly stated as country of origin, but the manufacturer is Wuhan Zonsen Medical Products Co., Ltd, in Wuhan, Hubei, China. The study is a non-clinical study (implicitly prospective as it's for a new device submission).

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

Not applicable. This is a non-clinical performance and biological evaluation of a medical device (surgical gown) based on standardized laboratory tests, not requiring expert ground truth in the clinical sense (e.g., radiologists interpreting images).

4. Adjudication method for the test set

Not applicable. The tests are based on objective physical and biological measurements according to established international and national standards.

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 document pertains to the performance testing of a physical medical device (surgical isolation gown), not an AI-assisted diagnostic or clinical decision support tool.

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

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the device's performance is established by the standardized test methods and their defined requirements/criteria. For example:

• Physical properties (e.g., tensile strength, tear strength, barrier performance) use established engineering and material science standards (e.g., ASTM, AATCC, ANSI/AAMI PB70:2012).
• Biocompatibility (cytotoxicity, irritation, sensitization) uses internationally recognized ISO standards (ISO 10993 series).

8. The sample size for the training set

Not applicable. This is a non-clinical study for a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, for the same reason as point 8.

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The Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

The proposed Surgical Isolation Gown is constructed of Polypropylene SMS non-woven material with the color in blue. The melt-blown nonwovens are made of polypropylene. The Surgical isolation gown is different in size. The size of surgical isolation gown is divided into seven groups: S(160), M(165), L(170), XL(175), XXL(180), 3XL(185), 4XL(190).

The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

The device description of the Surgical Isolation Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

The provided text describes the regulatory clearance for a medical device, a Surgical Isolation Gown, and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. This document is a 510(k) summary, not a study describing the development of an AI algorithm or its performance in a clinical setting. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

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

The acceptance criteria for the Surgical Isolation Gown are primarily based on established industry standards and regulatory guidance for barrier performance, physical properties, flammability, and biocompatibility. The reported device performance is compared against these standards.

Table of Acceptance Criteria and Device Performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (number of gowns or material samples) used for each non-clinical test. The tests were performed according to recognized ASTM, AATCC, ISO standards, and FDA guidances. The data provenance is described as non-clinical tests performed on the proposed device, manufactured by YANBIAN PACIFIC TEXTILE CO., LTD in China. These would be prospective tests specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The device is a surgical isolation gown, not an AI or diagnostic device that requires expert ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" for this device's performance is derived from standardized physical, chemical, and biological testing methods as defined by the mentioned international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers provide interpretations (e.g., radiological reads) and disagreement needs to be resolved. This is a physical device subject to standard laboratory testing.

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-assisted diagnostic or interpretative device.

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

Not applicable. This is not an AI algorithm. The performance described is for a physical product, the Surgical Isolation Gown, in a standalone testing environment (laboratory tests).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is based on the objective measurements and pass/fail criteria defined within the specified international standards (e.g., AAMI PB70:2012 for barrier performance, ISO 10993 for biocompatibility, ASTM for physical properties).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model or algorithm that requires a training set.

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

Not applicable. As above, there is no training set mentioned or required for this type of device submission.

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The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).The Surgical Isolation Gown is a single use, disposable medical nonsterile.

The proposed SURGICAL Isolation Gown is constructed of polyolefin (Polypropylene) SMS nonwoven material with the color in yellow. The SURGICAL Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings. The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.

This document is a 510(k) premarket notification for a Surgical Isolation Gown. It aims to demonstrate substantial equivalence to a predicate device. Here's an extraction of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on meeting AAMI Level 3 barrier protection requirements as per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, and demonstrating biocompatibility.

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

The document does not explicitly state the sample size for each performance test. However, for "Liquid Barrier Performance Classification Properties" for the proposed device, it mentions that "The critical zone areas tested were the chest, the back, the sleeve seam, the belt seam and side seam."

The data provenance is from non-clinical testing performed by Jingzhou Haixin Green Cross Medical Products Co., Ltd in China, as indicated by the applicant's address. The data is retrospective in the sense that these tests were conducted to support the 510(k) submission, not as a prospective clinical study involving human subjects.

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

This document describes a medical device (surgical gown) and its physical and barrier properties. It relies on standardized testing protocols (like ANSI/AAMI PB70:2012, AATCC, ASTM, ISO) rather than expert-derived ground truth from imaging or clinical data. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic algorithms is not applicable here. The "ground truth" is established by the specified test methods and their performance criteria.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective physical and chemical measurements based on industry standards, not subjective interpretations 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

Not applicable. This is a submission for a physical medical device (surgical gown), not an AI/software as a medical device.

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

Not applicable. This is a submission for a physical medical device (surgical gown), not an AI/software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is defined by the standardized test methods and their predetermined acceptance criteria (e.g., AAMI Level 3 specifications for barrier performance, Class I for flammability, non-cytotoxic/non-irritating/non-sensitizing for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of device submission.

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