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The Kimberly-Clark* MicroCool* Breathable High Performance Surgical Gowns, are 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 MicroCool* Breathable High Performance Surgical Gowns meet the Level 4 requirements of the AAMI Liquid Barrier classifications.

The Kimberly-Clark* MicroCool* Breathable High Performance Surqical Gowns, are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

The MicroCool* Breathable High Performance Surgical Gowns are manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a three-layer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond/meltblown/spunbond (SFSMS) design. The film layer is a multi-layer polypropylenebased, breathable film. A C6 fluorochemical treatment is added to the film to retard penetration by low surface tension fluids. A polyolefin hot melt adhesive is used to laminate the facing layers. to the film layer to complete the composite.

Here's a breakdown of the acceptance criteria and study information for the Kimberly-Clark MicroCool Breathable High Performance Surgical Gown, based on the provided text:

Important Note: This document describes the "substantial equivalence" of the device to a predicate device, meaning it meets the same standards. It doesn't detail a study comparing performance against human readers or a standalone algorithm, as it's a physical device, not an AI/software product. Therefore, sections related to AI/MRMC studies, number of experts, and training data provenance are not applicable and will be marked as such.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text for each specific test. The text indicates "testing" was done in compliance with the listed standards. These standards typically define minimum sample sizes for material testing.
• Data Provenance: Not explicitly stated. This is a physical product test, so "country of origin of the data" or "retrospective/prospective" study design in the context of data collection for AI is not directly applicable. The data would derive from laboratory testing of the gown materials.

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

• Not Applicable: This is a physical device subject to standardized material performance testing, not a diagnostic device requiring expert interpretation of results. The "ground truth" is established by the defined parameters and methods within the referenced ASTM, AAMI, CPSC, and ISO standards.

4. Adjudication Method for the Test Set

• Not Applicable: As this involves standardized material testing, there is no "adjudication method" in the sense of reconciling multiple expert opinions on a diagnostic outcome. The results of the tests are objectively measured against the criteria established by the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No: This is a physical surgical gown. An MRMC study is relevant to diagnostic or interpretation devices, typically involving human readers (e.g., radiologists) and an AI system. This device does not involve such a comparative effectiveness study.

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

• No: This device is a physical product, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

• Standardized Test Results/Compliance with Performance Standards: The "ground truth" is defined by the objective performance criteria and methodologies outlined in the referenced national and international standards (ANSI/AAMI PB70:2003, ASTM1671:2003, CPSC 1610, ISO 10993). The device's materials are tested against these established benchmarks.

8. The Sample Size for the Training Set

• Not Applicable: This is a physical device and does not involve AI or machine learning, therefore there is no "training set" in this context. The product design is based on material science and engineering, not data training.

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

• Not Applicable: As there is no training set for this physical device, this question is not relevant.

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The Kimberly-Clark* MicroCool* Surgical Gown, Breathable High Performance, KC 400 (hereinafter referred to as "MicroCool* Surgical Gown") are 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 MicroCool* Surgical Gowns meet the Level 4 requirements of the AAMI PB70: 2003 Liquid Barrier classifications.

The MicroCool* Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

The MicroCool* Surgical Gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a threelayer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond design and is adhesively laminated. The spunbond layers are comprised of nonwoven polypropylene. The film layer is a multi-layer polypropylene olefin, breathable film. A fluorochemical treatment is added to the film to retard penetration by low surface tension fluids. A polyolefin hot melt adhesive is used to laminate the Spunbond facing lavers to the film layer to complete the composite. A new sleeve design was incorporated to meet Level 4 of the AAMI Liquid Barrier classifications.

The request is for information regarding acceptance criteria and a study proving device performance, relevant to a medical device. However, the provided text describes a Kimberly-Clark MicroCool Surgical Gown, which is a physical product (surgical apparel), not a diagnostic algorithm or AI device that would typically have the requested criteria like "test set," "ground truth," "MRMC study," or "training set."

Therefore, the specific information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 for an AI/algorithm-based device is not applicable to this submission.

Here's the closest interpretation of the provided text in relation to the request:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This device is a physical product, not an algorithm, so "test set" in the context of data provenance is not relevant. The testing involved physical samples of the gowns. The document does not specify the number of gowns or material samples tested for each criterion, nor their provenance in the sense of data origin.

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. "Ground truth" in the context of expert review is for classification or diagnostic tasks. For physical product performance, the "ground truth" is defined by the objective performance standards themselves (e.g., AAMI PB70, ASTM1671, CPSC 1610, ISO 10993) and measured through standardized laboratory tests. The experts involved would be laboratory technicians or engineers performing the tests, but no "ground truth" establishment by medical experts is mentioned.

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

• Not applicable. Adjudication methods are typically used for reconciling disagreements among human readers or expert reviewers in diagnostic studies. For standardized physical product testing, the results are typically quantitative measurements against defined thresholds, not subjective interpretations 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. An MRMC study is for evaluating diagnostic performance, often involving AI assistance to human readers. This device is a surgical gown, not an AI diagnostic tool.

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

• Not applicable. This concept applies to AI algorithms, not physical medical devices like surgical gowns.

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

• Performance standards and laboratory test results. For this device, the "ground truth" is established by the specified industry standards (e.g., AAMI PB70 Level 4 for liquid barrier, ASTM1671 for viral penetration, CPSC 1610 for flame resistance, ISO 10993 for biocompatibility). The device's performance is objectively measured against these established-in-standard criteria in a laboratory setting.

8. The sample size for the training set

• Not applicable. This concept applies to machine learning models, not physical products.

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

• Not applicable. This concept applies to machine learning models, not physical products.

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The MicroCool Surgical Gown and the MicroCool Isolation Gown are single use items of surgical apparel intended to be worn by health are worker from the transfer of microorganisms, body fluids and particulate matter.

The MicroCool gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric, The fabric is a three-layer lamination that resists tearing and penetration by liquids. This disposable gown is supplied sterile or non-sterile.

This document describes the acceptance criteria and study results for the Kimberly-Clark MicroCool™ Surgical Gown and Isolation Gown.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gowns tested for fluid penetration). The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin specified. It is implied that the testing was conducted by or for Kimberly-Clark Corporation for regulatory submission to the FDA (USA).

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

This type of device (surgical gown) does not typically involve "expert" assessment for establishing ground truth in the same way a diagnostic imaging device would. The ground truth for these tests is defined by established scientific standards, methods, and regulatory requirements (e.g., USP XXIII, ASTM standards, CFR regulations). No number of experts or their qualifications are mentioned for establishing these ground truths, as they are based on standardized laboratory protocols.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically relevant for subjective assessments, particularly in clinical studies or image interpretation. For the chemical and physical tests conducted on the surgical gown, the results are objective and determined by laboratory equipment and standardized procedures. Therefore, no adjudication method is indicated or required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This type of study is not applicable to the evaluation of surgical gowns, which are assessed based on their material properties and barrier performance rather than diagnostic accuracy or human interpretation.

6. Standalone Performance Testing

The performance data presented in the "Summary of Testing" table is standalone performance, as it measures the intrinsic properties of the device (gown material) against established standards and criteria, without human intervention in the loop for assessment (beyond conducting the standardized tests).

7. Type of Ground Truth Used

The ground truth used for these tests is objective standards and regulatory requirements. This includes:

• USP XXIII requirements (for cytotoxicity)
• 16 CFR Part 1610 (for flammability)
• ASTM 1670-97 & ASTM F 903-96 (for fluid penetration)
• ASTM F 1671-97a (for viral penetration)
• Proposed FDA limits (for sterilant residues)

8. Sample Size for the Training Set

Surgical gowns are not typically "trained" in the way an AI algorithm is. Therefore, there is no "training set" in this context. The manufacturing process and quality control would be analogous to a training process, ensuring the gown consistently meets specifications, but there isn't a data set used for iterative algorithm improvement.

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

As there is no training set for this device, a ground truth for a training set was not established. The "ground truth" for the overall device performance relies on its ability to consistently meet the objective standards outlined in section 7 during manufacturing and quality assurance.

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The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

Not Found

The provided document is a 510(k) clearance letter from the FDA for several air purifier devices (Microcon 800M, 400M, Ex, ExC and Wall-Map Air Purifier). It states that the devices are substantially equivalent to pre-amendment devices for the indication of filtering airborne particles from air for medical purposes.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information. The letter only grants market clearance based on substantial equivalence, implying that the manufacturer would have submitted data to demonstrate this equivalence in their 510(k) submission, but that data is not part of this letter.

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The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a previously marketed device. It acknowledges the device's indications for use but does not detail any performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be necessary to answer your request.

The text is a regulatory approval document and not a scientific study report.

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