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Plus Medical Cover Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. The gowns are single use and disposable medical device provided sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 1135-1.

Plus Medical Cover Gowns meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

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The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "Plus Medical Cover Gown." This document pertains to the regulatory clearance of a physical medical device (surgical gown) and does not contain information about a software-as-a-medical-device (SaMD) or an AI/ML-based device.

Therefore, I cannot extract the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, or training sets, as these concepts are specifically relevant to the evaluation of AI/ML algorithms, not to the physical characteristics and testing of a surgical gown.

The document primarily focuses on:

• The device name: Plus Medical Cover Gown
• Regulation number and name: 21 CFR 878.4040, Surgical Apparel
• Regulatory class: Class II
• Product Code: FYA
• Indications for Use: Intended to be worn by healthcare professionals to protect both patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate matters.
• Sterilization: Single use and disposable, provided sterile or sold in bulk for EtO sterilization.
• Performance standard cited: AAMI Level 4 per ANSI/AAMI PB70:2012 for liquid barrier performance.

To answer your request, I would need a document detailing the evaluation of an AI/ML medical device, typically a clinical performance study report or a 510(k) summary for such a device.

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Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

The provided document does not describe a study involving an AI/ML device, therefore, much of the requested information cannot be extracted. The document is a 510(k) premarket notification for a medical device (Plus Medical Chemotherapy Gown) that is not an AI/ML product. It primarily focuses on the regulatory clearance process for this medical gown, particularly its barrier protection and resistance to chemotherapy drugs.

However, based on the information provided, here's what can be extracted:

1. A 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 sample sizes for testing or data provenance for the performance data of the Plus Medical Chemotherapy Gown. The tests mentioned (ANSI/AAMI PB70:2012 and ASTM F739-12) are likely conducted on samples of the gown material under controlled laboratory conditions, not on patient data.

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)

Not applicable, as this is a medical gown, not an AI/ML diagnostic device requiring expert review of medical images or data. The "ground truth" for the gown's performance is established through standardized laboratory testing protocols, not expert consensus on medical cases.

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

Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary. The performance is determined by physical and chemical 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 device is not an AI/ML product and therefore no MRMC study or assessment of AI assistance was performed.

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

Not applicable. This device is a physical medical gown, not an algorithm.

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

The "ground truth" for the performance of the Plus Medical Chemotherapy Gown is established by adherence to recognized industry standards and test methods:

• ANSI/AAMI PB70:2012: Liquid barrier performance is measured against the specifications of this standard.
• ASTM F739-12: Resistance to permeation of chemotherapy drugs is measured according to this standard test method.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth.

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Plus Medical Isolation Gowns Level 3 are intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters.

The gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. The gown is a full-back design and is provided non-sterile, single use medical device.

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I'm sorry, but the provided text only contains an FDA 510(k) clearance letter for a medical isolation gown. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria, specifically concerning an AI-powered device or diagnostic. The document pertains to a physical medical garment and its classification based on barrier protection standards, not an AI or software-based medical device.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop performance for an AI device.

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The Surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use. The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.

The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical specifications and comparative performance against a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/Machine Learning device or associated clinical performance evaluation. Therefore, I cannot provide information on acceptance criteria and study data related to AI/Machine Learning algorithm performance, ground truth establishment, expert adjudication, or MRMC studies.

However, I can extract the acceptance criteria and performance data for the physical properties and biological safety of the surgical face masks as presented in the document.

1. A table of acceptance criteria and the reported device performance for physical properties and biocompatibility:

The document presents performance data for both Level 2 and Level 3 surgical face mask models, as per ASTM F2100-19 standards. The testing was conducted on samples from "3 non-consecutive lots."

Table of Acceptance Criteria and Reported Device Performance (Surgical Face Mask - Physical and Biocompatibility Testing)

Note on Cytotoxicity: The comparison table explicitly states "Fail" for cytotoxicity, even though the reported result in the detailed performance tables states "show potential cytotoxicity" and a criterion of "Grade ≤ 2". This is a critical point of difference from the predicate device which was "not cytotoxic." The FDA's clearance likely implies that this difference did not raise new questions of safety or effectiveness given the overall risk-benefit profile for this type of device.

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

• Sample Size: For Flammability, Bacterial Filtration Efficiency, Differential Pressure, Sub-Micron Particle Filtration Efficiency, and Resistance to Penetration by Synthetic Blood, the testing was conducted on samples from "3 non-consecutive lots." The number of individual samples tested per lot is indicated for Flammability and Resistance to Penetration by Synthetic Blood, showing 32 out of 32 pass for flammability and ≥29 out of 32 pass for synthetic blood penetration. The exact sample sizes for BFE, Differential Pressure, and PFE for each lot are not explicitly stated as a count, but they are implied to be sufficient for generating the reported average percentages/values from the 3 lots.
• Data Provenance: The document does not specify the country of origin of the data. It is a submission from "Foshan Nanhai Plus Medical CO LTD" in China. The testing appears to be retrospective as it is presented as completed performance data for a device already manufactured.

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

• This is not applicable to the tests described. The "ground truth" for the performance tests (e.g., BFE, PFE) is established by the standardized testing protocols (e.g., ASTM F2100) and laboratory measurements, not by expert consensus or interpretation of images/clinical data. For biocompatibility, it's based on standard biological evaluation protocols (e.g., ISO 10993 series).

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

• Not applicable. The tests are laboratory-based measurements with defined pass/fail criteria, not subjective assessments requiring expert 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 document pertains to a physical medical device (surgical face mask) and its performance characteristics, not an AI/Machine Learning algorithm. No MRMC study was conducted or is relevant to this device's evaluation.

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

• Not applicable. This document is for a physical device, not an algorithm.

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

• The "ground truth" for the device's performance is derived from standardized physical and chemical testing methods using established protocols (e.g., ASTM F2100 for filtration, differential pressure, flammability, synthetic blood penetration; ISO 10993 for biocompatibility). The results are quantitative measurements against predefined criteria.

8. The sample size for the training set:

• Not applicable. This is not an AI/Machine Learning device; thus, there is no "training set."

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

• Not applicable for the same reason as above.

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The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) are sterile and non-sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.

The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) meets the level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.

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The provided text describes the regulatory clearance of a surgical gown and does not contain information about the acceptance criteria or a study related to a medical device's performance in terms of accuracy, sensitivity, specificity, or other typical performance metrics for diagnostic or AI-powered devices.

The document states that the "Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) meets the level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities." This indicates that the acceptance criteria for the gown's barrier performance are the Level 3 requirements of ANSI/AAMI PB70:2012. However, the document does not provide the specific reported performance values or details of the study that proves the device meets these criteria. It only asserts that it "meets" them.

Therefore, I cannot fill in the requested table or answer most of the questions as the necessary information is not present in the provided text.

Here's a breakdown of what cannot be extracted from the text:

• 1. A table of acceptance criteria and the reported device performance: The acceptance criterion mentioned is "Level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance." However, the reported device performance against this standard (e.g., specific test results, values for hydrostatic pressure, impact penetration, etc.) is not detailed in the document.
• 2. Sample sized used for the test set and the data provenance: Not applicable as specific performance testing details are not provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 is about surgical gowns, not an AI-powered diagnostic device or an AI assistance system.
• 6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a surgical gown would be its physical barrier properties as measured by standardized tests.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The document focuses on the regulatory clearance process for a medical device (surgical gowns) based on its compliance with established industry standards for barrier performance (ANSI/AAMI PB70:2012 Level 3) and sterilization validation (ethylene oxide process according to ISO 11135-1). It does not delve into the detailed results of the tests performed to demonstrate this compliance.

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