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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.

Device Description

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.

AI/ML Overview

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

Test Criteria	Acceptance Criteria	Reported Device Performance
Biocompatibility
Cytotoxicity	Test scores 0.4).	Pass
Performance Testing
Tearing Strength/Resistance (ASTM D5587)	The average tear strength in both Machine and Cross-Machine Directions was assessed per ASTM F2407 – 2020.	Pass (Specific numerical results reported in the comparison table on page 5: 15.98±0.68N (Machine Direction) and 9.41±0.46N (Transverse Direction))
Tensile Strength (ASTM D5034)	The average tensile strength in both Machine and Cross-Machine Directions was assessed per ASTM F2407 - 2020.	Pass (Specific numerical results reported in the comparison table on page 5: 41.74±2.74N (Machine Direction) and 30.29±3.52N (Transverse Direction))
Seam Strength (ASTM D1683)	The average seam strength values were assessed per ASTM F2407 - 2020.	Pass (Specific numerical results reported in the comparison table on page 5: 35.01±3.91 N and 7.87±0.88 lb)
Hydrostatic Pressure Test (AATCC 127)	≥50cm	Pass
Impact Penetration (AATCC 42)	≤1.0g	Pass
Mass Per Unit Area (Weight) of Woven Fabric (ASTM D3776/D3776M)	Basis Weight per ASTM D3776/D3776M	Lot 1: 27.67 ± 0.58 / Lot 2: 28.00 ± 3.46 / Lot 3: 30.67 ± 0.58
Tensile Properties of Thin Plastic Sheeting (ASTM D882)	Determination of tensile properties of plastics in the form of thin sheeting and films (less than 1.0 mm (0.04 in.) in thickness).	Average Machine data for 3 Lots: Load at Break (N) 12.79±1.21; Tensile Strength (Mpa) 16.64±3.40; % Elongation at Break 410.76±50.67. Average Cross data for 3 Lots: Load at Break (N) 10.19±1.03; Tensile Strength (Mpa) 11.43±3.95; %Elongation at Break 522.42±58.80.
Tear Resistance (Graves Tear) of Plastic Film and Sheeting (ASTM D1004)	Determination of the tear resistance of flexible plastic film and sheeting at very low rates of loading, 51 mm (2 in.)/min.	Average Machine data for 3 Lots: Maximum Load (N) 2.93±0.34; Extension at Break (mm) 19.84±3.57. Average Cross data for 3 Lots: Maximum Load (N) 3.23±0.20; Extension at Break (mm) 22.50±1.4.
Flammability of Clothing Textiles (16 CFR Part 1610)	Average burn time ≥ 3.5s; Class 1 "normal Flammability" in accordance to 16 CFR Part 1610.	Pass

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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