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Surgical Gown is intended to be worn by room personnel during surgical procedures or other invasive tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided sterile.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 2 classification, and the reinforced surgical gowns met the requirements for Level 3 classification.

The proposed devices Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.

The proposed device Surgical Gown is model ZSG1005, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in M, L, XL sizes. This proposed device can meet the requirements for Level 2 per ANSI/AAMI PB70:2012.

The proposed device Reinforced Surgical Gown is model ZSG1006, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in M. L. XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

The proposed devices are disposable medical devices and provided in sterile.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Surgical Gown, Reinforced Surgical Gown (Wuhan Zonsen Medical Products Co.,Ltd)

1. Table of acceptance criteria and the reported device performance:

2. Sample size 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 sample sizes used for each individual non-clinical test (e.g., how many surgical gowns were tested for flammability or hydrostatic pressure).
• The data provenance is from China, as the applicant is "Wuhan Zonsen Medical Products Co.,Ltd" located in Wuhan, Hubei Province, China.
• The studies were prospective as they were conducted to verify the device met design specifications for regulatory 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 information is not applicable to this type of device (surgical gowns) and the non-clinical tests performed. These tests are standardized laboratory evaluations, not subjective expert assessments.

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

• This information is not applicable. The tests are objective laboratory measurements against defined numerical or categorical criteria rather than requiring adjudication of subjective expert opinions.

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:

• No MRMC comparative effectiveness study was done. This study is for a physical medical device (surgical gown), not an AI-powered diagnostic tool.

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

• No standalone algorithm performance study was done. This device is a physical product, not an algorithm.

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

• The ground truth for these tests is based on established industry standards and test methodologies (e.g., ISO 10993-5, AATCC 127, ASTM D5034, AAMI/ANSI PB70:2012). The "ground truth" is defined by the acceptance criteria set forth in these standards (e.g., hydrostatic pressure >20 cm, flammability Class 1).

8. The sample size for the training set:

• Not applicable. This device is a physical product, not a machine learning model, therefore, there is no "training set."

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

• Not applicable. As there is no training set, there is no ground truth established for it.

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