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The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

Device Description

The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and a blue color.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically a "Disposable Surgical Gown (UM-148)". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are about showing that the new surgical gown performs comparably to established standards and a predicate device, rather than proving a new clinical claim.

Here's an analysis of the provided information, formatted as requested:

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

Acceptance Criteria / Standard (Ref.)	Reported Device Performance
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities. Level 3: When tested for water resistance in accordance with AATCC 42 (impact penetration) and AATCC 127 (hydrostatic pressure) and all critical zone components shall have a blotter weight gain of no more than 1.0 g and a hydrostatic pressure of >50 cm.	Level 3 (The device meets Level 3 requirements for Liquid Barrier Performance and Classification)
ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure: ≥10 N	PASS MD: 45.5N CD: 28.2N (Average result from 10 samples)
ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test): ≥30N	PASS MD: 145.4N CD: 91.4N (Average result from 10 samples)
ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics: ≥30N	PASS 52.6N (Average result from 10 samples)
AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test: ≤1.0 g	PASS 0 g (Average result from 3 nonconsecutive batches)
Evaporative Resistance ASTM F1868-17: < 3 Pa.m²/W.	PASS 2.36 Pa.m²/W. (Average result from 13 samples)
AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test: >50 cm	PASS 65~72 cm (Average result from 3 nonconsecutive batches)
CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles: Meets Class I requirements	PASS Class I (Average result from 5 samples)
ISO 9073- 10:2003(E) Lint and Other Particles Generation: Log10(particle count) < 4	PASS 2.0 (Average result from 13 samples)
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization: Non-irritating, and Non-sensitizing.	PASS Under the conditions of the study, the device is non-irritating, and non-sensitizing.
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity: Non-cytotoxic.	PASS Under the conditions of the study, the device is non-cytotoxic.

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

Tearing Strength (ASTM D5587-15): 10 samples.
Breaking Strength and Elongation (ASTM D5034-09): 10 samples.
Failure in Sewn Seams (ASTM D1683M-17): 10 samples.
Water Penetration Resistance (AATCC 42-2013): 3 nonconsecutive batches.
Evaporative Resistance (ASTM F1868-17): 13 samples.
Water Resistance: Hydrostatic Pressure Test (AATCC 127-2014): 3 nonconsecutive batches.
Flammability (CPSC 16 CFR Part 1610-2008): 5 samples.
Linting (ISO 9073-10:2003(E)): 13 samples.
Biocompatibility (ISO 10993-10 and ISO 10993-5): Sample sizes for the specific in vitro and in vivo tests are not explicitly stated, but the tests were performed "under the conditions of the study".

The data provenance is from non-clinical tests conducted by or on behalf of Unimax Medical Products Co., Ltd. in China. These are prospective tests performed on the proposed device to demonstrate its performance against recognized industry standards.

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

Not applicable. This is a submission for a physical medical device (surgical gown) where performance is measured against established scientific and engineering standards for materials and protective properties, not based on expert interpretation of observational data. The "ground truth" is defined by the objective metrics specified in the test methodologies (e.g., N for strength, g for water penetration, cm for hydrostatic pressure).

4. Adjudication method for the test set

Not applicable. Performance is measured against quantitative and qualitative criteria defined by the respective standards, and the results are reported directly (e.g., "PASS", "45.5N"). There is no subjective interpretation or adjudication process involved as would be the case for image-based diagnostic AI, for example.

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 not an AI-enabled diagnostic device. It is a physical product (surgical gown).

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

Not applicable. This is not an AI-enabled diagnostic device.

7. The type of ground truth used

The ground truth is based on established industry standards and objective physical measurements. For example:

AAMI/ANSI PB70:2012 defines liquid barrier performance levels.
ASTM standards define methods and acceptance criteria for material strengths (tearing, breaking, seam).
AATCC standards define methods for water resistance.
CPSC 16 CFR Part 1610 defines flammability classes.
ISO 9073-10 defines linting criteria.
ISO 10993 standards define biocompatibility criteria based on in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The tests are directly measuring the physical properties of the manufactured product.

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

Not applicable. There is no training set for this type of device.

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