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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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The Disposable Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Surgical Masks are green color, three-layer, flat-folded masks with nose piece and ear loops. The green colorant is polypropylene (PP) master batch.

The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are not made with natural rubber latex or fiberglass, but nylon and spandex.

The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of Iron core coated with Polyethylene.

The Disposable Medical Surgical Masks are sold non-sterile and are intended to be single use, disposable devices.

The provided document is a 510(k) Premarket Notification from the FDA for a Disposable Medical Surgical Mask. It details the device's technical specifications, intended use, and comparison to a predicate device, as well as the results of non-clinical performance and biological safety tests.

However, the request asks for specific information related to acceptance criteria and a study proving a medical device meets these criteria, particularly focusing on aspects like AI assistance, human reader performance improvement, ground truth establishment, sample sizes for training and test sets, and expert involvement. The document describes a surgical mask, which is a physical product, not a medical device that would involve AI, image analysis, or human reader performance in the context of the questions asked.

Therefore, many of the questions asked (e.g., about AI, human readers, ground truth for training/test sets, MRMC studies) are not applicable to the information provided in this document, which pertains to the physical and biological performance of a surgical mask.

I will interpret the request as asking about the acceptance criteria and proof of performance as presented in this document for a surgical mask, acknowledging that many of the AI/image analysis specific questions are not relevant here.

Here's an analysis based on the provided document:

Acceptance Criteria and Study Proving Device Meets Criteria (for a Disposable Medical Surgical Mask)

The study described in this document is a non-clinical performance and biological safety evaluation conducted to demonstrate substantial equivalence of the Disposable Medical Surgical Mask to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document indicates that for the Fluid Resistance test, "32" samples were tested (implied per lot, across 3 lots). For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure, results are presented for "3 lots" (e.g., 98.8%; 98.8%; 98.8%), suggesting samples were drawn from these lots for testing. Specific sample numbers per test within each lot are not explicitly detailed beyond the fluid resistance test.
• Data Provenance: The tests were conducted by Suzhou JaneE Medical Technology Co., Ltd. (China) or subcontracted labs. The document does not specify the country of origin of the data in terms of patient data, as this is a non-clinical product. The data provenance is from laboratory testing performed on the manufactured product. It is a prospective test in the sense that the manufacturer conducted these tests specifically for this 510(k) submission on samples of their manufactured device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This device is a surgical mask, and the "ground truth" is established by direct physical and biological testing of the product's material properties and performance against established international standards (ASTM, ISO, EN, CFR) rather than expert interpretation of medical images or patient outcomes. The acceptance criteria are objective laboratory measurements.

4. Adjudication Method for the Test Set

• Not applicable. This refers to methods for consolidating expert opinions (e.g., in reading medical images). For physical and biological tests of a surgical mask, the results are typically quantitative measurements or pass/fail determinations based on predefined criteria, not subject to subjective adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is relevant for diagnostic devices where human readers interpret medical data (e.g., radiologists reading scans). This document describes the testing of a physical product (surgical mask). Therefore, no MRMC study was performed or is relevant to this device.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• No. This question applies to AI/software as a medical device (SaMD). The device is a surgical mask, which does not involve an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" here is based on objective, quantitative laboratory measurements against established national and international standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, ISO 10993 parts, 16 CFR 1610) that define the performance characteristics of surgical masks. These standards themselves are developed through expert consensus and empirical data regarding the physiological and protective functions of such devices.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of a physical medical device like a surgical mask. This term refers to data used to train machine learning models.

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

• Not applicable. As there is no training set for a surgical mask, this question is irrelevant.

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