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The AAMI Level 4 Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The AAMI Level 4 Protective Gown 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; but has an open back which is non-protective.

The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile.

The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile. It has an open back which is non-protective.

This document is a 510(k) clearance letter for an AAMI Level 4 Protective Gown. It is not a study report for a diagnostic device or an AI/software-as-a-medical-device (SaMD) product. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not applicable to this document.

The document states that the device "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". This indicates the performance standard the device is intended to meet, but it doesn't provide the detailed acceptance criteria or a study write-up in the format requested for a software device.

In summary, the provided text does not contain the information necessary to answer the specific questions about acceptance criteria, study design, and performance metrics as it pertains to a diagnostic or AI device. It is a regulatory clearance for a physical medical device (a protective gown).

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Gown is a single use, disposable, non-solation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situations.

The Medline Open-Back Level 3 Protective Gown is a single use, disposable, non-sterile, nonisolation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situation. The Medline Open-Back Level 3 Protective Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities".

The Medline Open-Back Level 3 Protective Gown is a blue polyethylene gown available in 3 configurations: regular/large, universal and XL. The gown has an open back with a tie for securement and thumb loops on the cuffs.

The document provided is a 510(k) summary for the Medline Open-Back Level 3 Protective Gown. It describes the device, its intended use, and a comparison to a predicate device. The information details non-clinical performance and biocompatibility testing results.

Here's a breakdown of the requested information:

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 explicitly state the specific sample size for each individual test (e.g., how many gowns were tested for tear strength). However, it implies that the tests were conducted on representative samples of the Medline Open-Back Level 3 Protective Gown. The provenance of the data is not specified (e.g., country of origin or whether it was retrospective or prospective). It is generally assumed that such testing is prospective, meaning it's performed specifically for the 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 is not applicable to the type of device and testing performed. The device is a protective gown, and its performance is evaluated through standardized physical and biological tests, not through expert interpretation of data.

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

This is not applicable as the testing involves objective measurements based on established test methods and standards, not subjective expert assessment 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

This is not applicable. The device is a physical protective gown, not an AI-powered diagnostic tool, so MRMC studies are irrelevant.

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

This is not applicable. The device is a physical garment, not an algorithm.

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

The "ground truth" for this device is established by international and national standards (e.g., ANSI/AAMI PB70, ISO 10993, ASTM, AATCC, 16 CFR Part 1610). The device's performance is measured against the specifications and requirements outlined in these standards.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of testing a physical medical device like a protective gown.

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

This is not applicable, as there is no training set for this type of device.

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The PolyWear® Personal Protection Level 3 Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

The PolyWear® Personal Protection Level 3 Gown meets the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).

The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective.

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "PolyWear® Personal Protective Level 3 Gown." This document outlines the regulatory approval for the gown and its intended use, but it does not contain information about acceptance criteria for an AI/ML device, nor does it describe a study proving the device meets such criteria.

The document primarily focuses on:

• Regulatory Classification: Identifying the device as a Class II surgical apparel.
• Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices.
• General Controls: Listing the general regulatory requirements the manufacturer must adhere to.
• Indications for Use: Describing the intended purpose of the gown to protect against microorganisms, body fluids, and particulate material, specifically mentioning it meets AAMI Level 3 barrier protection.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of AI/ML, as this document pertains to a physical medical garment and not a software-based AI/ML device.

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Protective gown AAMI Level 4 is intended to protect health care personnel and patients from transfer of microorganisms, body fluids and particulate material. The Protective Gowns is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

Protective Gown AAMI Level 4

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Protective Gown AAMI Level 4" does not contain the information required to answer your request about acceptance criteria and a study proving a device meets these criteria.

The document is a regulatory clearance letter for a medical device (a protective gown), and as such, it focuses on the administrative aspects of regulatory approval, such as:

• Device name and product code
• Regulation number and name
• Regulatory class
• Date of submission and receipt
• Determination of substantial equivalence
• General controls provisions and other applicable regulations (e.g., registration, listing, labeling, GMP)
• Contact information for regulatory questions

It does not include details about:

1. Acceptance criteria table and reported device performance: This type of information would typically be found in test reports, design specifications, or a summary of safety and effectiveness (SSE) document that supports the 510(k) submission, not the clearance letter itself. For a protective gown, acceptance criteria would likely involve fluid barrier properties (e.g., AAMI Level 4 standards for liquid barrier performance), tensile strength, tear resistance, and other material properties.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study information.
6. Standalone (algorithm only) performance information.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

These points are highly relevant to studies involving AI/ML medical devices or complex diagnostic/imaging devices, where performance metrics like sensitivity, specificity, AUC, and expert reader studies are crucial. The device in question, a protective gown, is a physical barrier device, and its performance is evaluated through standardized material testing, not typically through human reader studies or AI algorithms.

Therefore, I cannot fulfill your request based on the provided text.

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The Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room.

The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective.

These gowns are single use, disposable medical devices provided non-sterile.

Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material These gowns are not intended - for use in the operating room. The gowns are available on Regular and X-Large sizes.

Dukal AAMI Level 4 Open-Back Protective Gowns are made with laminate material (SMS nonwoven material with polyethylene film).

All gowns are blue, with neck removal feature, belt ties, and thumb hook cuff sleeves.

These gowns are single use, disposable devices, that are provided non-sterile.

The provided document is a 510(k) premarket notification for a medical device: Dukal AAMI Level 4 Open-Back Protective Gown. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories related to clinical trials, multi-reader multi-case studies, and AI-specific ground truth are not applicable.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: For the Liquid Barrier Performance Classification test (ASTM F1671), the testing was performed using 3 lots and 32 samples per lot in each critical zone area (body/sleeve and heat-sealed seams). For other tests, specific sample sizes are not explicitly stated within the provided text, but the results are reported as meeting the requirements.
• Data Provenance: The nature of these tests (material properties) suggests they were conducted in a laboratory setting. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as these terms are not typically applicable to physical product testing of this kind.

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

Not applicable. These are non-clinical, objective material property tests and do not involve expert interpretation or ground truth establishment by medical professionals. The "ground truth" is determined by the standardized test methods and their defined pass/fail criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for dispute resolution or consensus building among human readers, typically in image interpretation or clinical diagnosis. These tests involve objective physical measurements against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools with human readers. The device in question is a protective gown, which is not an AI-powered diagnostic device.

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

No, a standalone algorithm performance study was not done. This device is not an algorithm or AI model.

7. The type of ground truth used

For this device, the "ground truth" is the objective, measurable performance against established industry standards (e.g., AAMI Level 4 requirements, ASTM, ISO, AATCC standards). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for a protective gown's material performance. The ground truth is embedded in the standardized test methods and their pass/fail criteria.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning model.

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

Not applicable, as there is no training set for this device.

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Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare persomel to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter.

The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/A AMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).

The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.

The Donagamex Blue Performance Protective Gown is a Class II medical device under the FDA product code QPC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Donagamex Blue Performance Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The Donagamex Blue Performance Protective Gowns are non-woven, blue gowns, available in various sizes and have no areas of reinforcement. They are made from a layer of polyethylene laminated over spun-bonded polypropylene and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a protective gown. The Donagamex Blue Performance Protective Gown is a single use, disposable medical device that will be sold non-sterile.

The provided text is related to the 510(k) premarket notification for a medical device: "Donagamex Blue Performance Protective Gown" (K203821). This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" largely refers to the non-clinical performance tests conducted to ensure the protective gown meets specific standards for barrier protection, material strength, flammability, and biocompatibility.

Here's a breakdown of the information as it can be extracted from the document, tailored to the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

Note: ASTM - D3776:2020 (Mass Per Unit Area) and ISO 9073-10 (Lint & other Particles Generation) were listed with purpose but "N/A" for acceptance criteria and results in the provided table, suggesting they were likely characterization tests rather than tests against specific acceptance thresholds for clearance in this context.

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

• Sample Size for Barrier Performance: For the AAMI PB70:2012 liquid barrier testing, the document states: "Testing was performed using 3 nonconsecutive lots and 32 samples per lot in each critical zone area." This means a total of 96 samples (3 lots * 32 samples/lot) were tested per critical zone (chest, back, and sleeve seam).
• Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the manufacturer is "Dong Nai Garment Corporation" located in Vietnam. The tests are referenced against international and US standards (AATCC, ASTM, ISO, CFR). The timeframe implies these tests were conducted retrospectively for the 510(k) submission.

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

• Not applicable for this type of device and study. This device is a protective gown, and the performance evaluation relies on standardized physical, chemical, and biological testing methods rather than expert interpretation of images or clinical outcomes. The "ground truth" is established by the test methods themselves and their defined pass/fail criteria.

4. Adjudication Method for the Test Set

• Not applicable. As the device is characterized by objective physical and material properties assessed via standardized tests, there is no human interpretation or adjudication process involved in the test results.

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 section is relevant for AI/ML-driven diagnostic devices that assist human readers (e.g., radiologists). The "Donagamex Blue Performance Protective Gown" is a Class II surgical apparel, not an AI/ML diagnostic device, and therefore, no MRMC study was conducted or is relevant. The study performed is a non-clinical performance study against established material and barrier standards.

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

• Not applicable. As explained above, this device is not an algorithm or AI system. Its performance is entirely standalone in terms of its physical properties. The tests performed are "standalone" in the sense that they evaluate the device's inherent properties without human interaction beyond conducting the test protocol.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective, standardized test methods and their defined performance criteria (e.g., AAMI PB70:2012 for liquid barrier, ASTM standards for material strength, CPSC 1610 for flammability, and ISO 10993 for biocompatibility). These are physical and biological measurements against pre-defined thresholds.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this device does not involve machine learning or AI models that require data for training. The product is manufactured and then tested to ensure it meets performance specifications.

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

• Not applicable. As there is no training set, there is no corresponding ground truth establishment process for it. The "ground truth" for demonstrating substantial equivalence and device performance is established through adherence to recognized consensus standards for material testing and barrier properties.

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ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

The ProTEC-USA EZDoff Gown is constructed of 41 gsm blue polyolefin (Polyethylene) film offered in one universal size. The body of the gown is provided with belt ties that are constructed of the same 41 gsm blue polyolefin (Polyethylene) film. The sleeves of the gown are sealed using a heat-sealing method.

The document describes the acceptance criteria and study results for the ProTEC-USA EZDoff Gown, a non-sterile, single-use protective medical gown.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Cardinal Health™ Poly-Coated Open-Back Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Not intended for use in the operating room.

The proposed Cardinal Health™ Poly-Coated Open-Back Protective Gown 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, but has an open back which is non-protective.

The Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use, disposable medical device provided non-sterile.

The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a Class II medical device under the FDA product code of FYC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Poly-Coated Open-Back Protective 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 Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.

The Cardinal Health™ Poly-Coated Open-Back Protective Gown consists of a laminate (blue spunbond polypropylene coated with polyethylene) throughout the body of the gown (including sleeves). The sleeves have a thumbhook cuff formed into the sleeve or have a knit cuff sewn onto sleeve for keeping the sleeves in place on the wearer. The collar has a neck removal feature and the belt ties are integrated into the body. These gowns are non-sterile, single use, disposable gowns that are packaged in pastic bags and/or dispenser boxes. These gowns are offered in blue and come in both Universal and XX-Large sizes.

The document describes the non-clinical performance testing of the Cardinal Health™ Poly-Coated Open-Back Protective Gown. It evaluates the device against specific acceptance criteria and details the study methods used.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

51 (51 / >51) inH20 |
| Viral barrier (ASTM F1671-13) | Pass | Pass |
| Liquid Barrier Performance Classification Properties (ANSI/AAMI PB70:2012 / ASTM F1671) | Meets AAMI Level 4 performance requirements | All areas tested meet Level 4 performance requirements |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing per ISO-10993-1 | Non-cytotoxic, non-irritating, non-sensitizing and met requirements per ISO-10993-1 |

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

• Liquid Barrier Performance Classification Properties: Testing was performed using 3 lots and 32 samples per lot in each critical zone area (body or sleeve, and heat sealed seam(s)).
• Other tests (Basis Weight, Tensile Strength, Tear Strength, Hydrostatic Head): The document provides mean and min/max values, but a specific sample size for these individual tests beyond the "Finished Good Test Results" is not explicitly stated.
• Data Provenance: The document implies that the testing was conducted internally by the manufacturer, Cardinal Health, or by a contracted lab. The data is presented as "Finished Good Test Results" for the "Subject Device: Cardinal Health™ Poly-Coated Open-Back Protective Gown." This data would be considered prospective as it's generated specifically for the device submission. The country of origin for the data is not specified, but the submission is to the U.S. FDA by a company based in Illinois, USA.

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

The tests described are non-clinical performance tests that use standardized methodologies (e.g., ASTM, AATCC, ISO standards) to measure physical and barrier properties. These types of tests do not typically involve human expert interpretation or "ground truth" in the same way clinical studies or diagnostic device evaluations would. The "ground truth" is established by the test method itself and the specified performance criteria. Therefore, no human experts were used to establish ground truth for this test set in the context of diagnostic interpretation.

4. Adjudication method for the test set

Not applicable. As noted above, these are non-clinical, objective performance tests following standardized methods, not subjective clinical assessments 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 protective gown, which is a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or presented.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

The ground truth for the non-clinical performance tests is based on predefined objective standards and specifications (e.g., AAMI Level 4 for barrier protection, specific tensile strength values, flammability classes). These standards define what constitutes a "pass" or "fail" for each characteristic.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, and 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 for this type of device.

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These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non-protective . They are not intended for use in the operating room.

SafeCare® Open Back Protective Gowns (Models: 46969-097X, 46969097XB, 46969097X-10, 46969-098 & 46969-098D) and ValueCare® Open Back (Model: 4550-25X) Protective Gowns are open back gowns made from extruded plastic film.

The SafeCare® and ValueCare® Open Back Protective gowns provide barrier protection to the wearer from body fluids and particulate materials and have passed barrier testing according to ANSI/AAMI PB70:2012 Level 3 protection or equivalent.

The significant design points of the gowns are:

1. Made from extruded plastic film to provide an effective barrier meeting the requirements for penetration testing as per ANSI/AAMI PB70: 2012 Level 3 according to AATCC 42:2013 and AATCC 127:2014 test methods.
2. Backless to provide comfort
3. Thumb loops at the wrist which help to hold gown sleeves down
4. Back has perforations so the gowns can be removed without taking over the head in case they are contaminated

The provided text describes information about the substantial equivalence of SafeCare® Open Back Protective Gowns and ValueCare® Open Back Protective Gowns to a predicate device, the Poly-Med Disposable Personal Protective Gown Apron. The information focuses on design, materials, indications for use, labeling, and various performance tests to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided text, noting where specific details are not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each test in a numerical or pass/fail threshold. Instead, it states that the device "meets" certain levels or is "non-irritating," "non-sensitizing," etc. The table below synthesizes the test results for the subject devices (SafeCare® and ValueCare® Open Back Protective Gowns) against relevant standards, effectively serving as the reported device performance. The "Acceptance Criteria" column reflects the standard or outcome deemed acceptable.

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

The document does not specify the sample sizes used for any of the tests (e.g., dermal irritation, sensitization, cytotoxicity, flammability, fluid penetration).

Regarding data provenance, the studies were conducted to support the 510(k) submission for BAM Corporation Limited, Hong Kong, China. The text does not explicitly state whether the studies were retrospective or prospective, but clinical trials are not mentioned, suggesting these are likely laboratory-based performance tests performed on the device itself.

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

This type of information is not applicable to this submission. The tests conducted are laboratory-based performance tests (e.g., biocompatibility and barrier testing) against established standards and test methods. They do not involve expert interpretation or ground truth establishment in the way clinical studies or diagnostic imaging studies would.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. As this submission describes laboratory performance tests, an adjudication method is 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This submission is for protective gowns and involves laboratory performance testing, not an AI-assisted diagnostic or interpretive device involving human readers.

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

This question is not applicable. The device is a protective gown, not an algorithm or software. The performance tests are for the physical properties of the gown.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the performance tests described, the "ground truth" is established by adherence to recognized international and national standards and test methods. For example:

• Biocompatibility (Dermal Irritation, Sensitization, Cytotoxicity): Ground truth is determined by the criteria and pass/fail results defined within ISO 10993-10:2010 and ISO 10993-5:2009.
• Flammability: Ground truth is defined by the success criteria outlined in 16 CFR Part 1610 (meeting Class 1).
• Fluid Penetration: Ground truth is the successful adherence to the Level 3 requirements of ANSI/AAMI PB70:2012, as measured by AATCC 127:2014 and AATCC 42:2013.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are used for machine learning algorithms. The device described, protective gowns, does not involve such algorithms. The tests performed are physical and biological property assessments of the manufactured product.

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

This question is not applicable as there is no training set for this type of device.

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