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The Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical non-sterile.

The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations.

The provided text describes the acceptance criteria and the results of non-clinical tests for an Isolation Gown. This is a medical device, specifically protective apparel, and not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this document.

Here's the relevant information based on the provided text for the Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)):

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)
The document does not explicitly state the sample sizes for each specific test but indicates that tests were performed on "Yellow Isolation Gown XXL" and "Blue Isolation Gown XXL". The tests are non-clinical, related to material properties of the gown. Data provenance (country of origin, retrospective/prospective) is not provided as this is an evaluation of a physical medical device, not a data-driven model.

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. This is a physical medical device (isolation gown), not an AI/ML device relying on expert interpretation for ground truth. Ground truth is established by physical and chemical testing standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical medical device, not an AI/ML device requiring adjudication of 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 is a physical medical device, not an AI/ML device.

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 AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is based on established international and national standards for performance and safety of protective apparel and medical devices. Specifically:

• ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities (for liquid barrier performance)
• AATCC 127-2018e (Water Resistance: Hydrostatic Pressure Test)
• AATCC 42-2017 (Water Resistance: Impact Penetration Test)
• ASTM D 5034-2009 (2017) (Breaking Strength and Elongation)
• ASTM D 5587-2015 (Tearing Strength)
• ASTM D1683/D1683M-2017 (2018) (Seam Strength)
• ISO 9073-10:2003 (Lint and other particles generation)
• ASTM F 1868-2017 (Thermal and Evaporative Resistance)
• 16 CFR Part 1610 (Flammability Test)
• ISO 9073-1:1989 (Mass Per Unit Area)
• ISO 10993-1:2018, ISO 10993-5, ISO 10993-10 (Biocompatibility)

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set with established ground truth.

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The Isolation Gown AAMI Level 3 is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities(ANSI/AAMI PB70). The Isolation Gown is single use, disposable medical device provided non-sterile.

Not Found

The provided text is related to the FDA 510(k) clearance for an "Isolation Gown AAMI Level 3" and primarily concerns regulatory approval. It does not describe a study involving a device with AI or software components that would typically have acceptance criteria presented in the requested format.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them, as the provided text pertains to a physical medical device (an isolation gown) and its regulatory clearance based on AAMI Level 3 barrier protection standards, not a software-driven device.

The information I can extract directly related to performance and standards is:

Acceptance Criteria for the Isolation Gown AAMI Level 3:

The provided document does NOT contain information regarding:

• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (beyond implying compliance with AAMI PB70 standards, which often involve laboratory testing for physical properties).
• Sample size for the training set.
• How ground truth for the training set was established.

This is because the cleared device is a physical barrier product, not an AI/software as a medical device (SaMD). The assessment for such devices typically involves laboratory testing against established standards (like AAMI PB70) rather than clinical studies with human readers or AI algorithms.

Ask a specific question about this device

Ask a specific question about this device