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The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.

The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.

The document is a 510(k) Premarket Notification from the FDA regarding a Disposable Surgical Gown. It outlines the device's technical specifications and compares it to a predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and safety testing required for regulatory clearance, not studies involving AI or human reader performance as one might expect for a diagnostic AI device.

Here's an analysis based on the provided document:

This document describes the testing for a Disposable Surgical Gown, which is a physical medical device, not a diagnostic AI/algorithm. Therefore, concepts like "MRMC comparative effectiveness study," "standalone algorithm performance," "human readers improve with AI," "number of experts for ground truth," "adjudication method," and "training set size/ground truth establishment" are not applicable to this type of medical device submission. The "acceptance criteria" relate to physical and biological performance characteristics of the gown.

Non-Clinical Performance and Safety Testing for Disposable Surgical Gown

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

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

The document states that results are "Average result from 3 nonconsecutive batches" for several tests (Tearing Strength, Breaking Strength, Seam Strength, Water Impact, Evaporative Resistance, Hydrostatic Pressure, Flammability, Linting). The specific number of gowns or material samples per batch is not explicitly stated but implies a representative sample was taken from different production runs.

• Provenance: "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The manufacturer is Suzhou JaneE Medical Technology Co., Ltd. in China, implying testing was conducted or overseen by them or a contracted lab. The document does not specify if the data is retrospective or prospective, but for manufacturing quality control and regulatory submission, it would typically be prospective testing on newly produced batches.

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

Not applicable. This pertains to an AI/diagnostic device. For a physical device like a surgical gown, "ground truth" is established by adherence to recognized international standards and laboratory testing protocols.

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

Not applicable. This pertains to an AI/diagnostic device and human reader disagreement. Physical testing relies on standardized methodologies and calibrated equipment.

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 relates to AI-assisted diagnostic performance.

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

Not applicable. This relates to AI algorithm performance.

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

The "ground truth" for this device is based on established international and national standards and test methodologies for material properties and barrier performance (e.g., AAMI PB70, ASTM, AATCC, ISO, CPSC). Compliance with these quantitative and qualitative standards serves as the benchmark for acceptance. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO 10993 standards.

8. The sample size for the training set:

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

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

Not applicable. This product is a physical device, not an AI algorithm.

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