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The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAM Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.

The Paneffort AAMI Level 3 Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. The Paneffort AAMI Level 3 Isolation Gown is a single use, disposable medical device provided non-sterile. Paneffort AAMI Level 3 Isolation Gown is offered in one color (blue) and six different sizes of Small, Medium, Regular/Large, X-Large, 2X-Large, and 3X-Large. Each model is constructed of a nonwoven Spunbond-Meltblown-Spunbond (SMS) material that is tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.

The Paneffort AAMI Level 3 Isolation Gown consists of one critical zone throughout the entire gown including seams, but excluding cuffs, hems, and bindings as per AAMI PB70:2012. It is a protective tape sealed gown along with other design features like tieneck, elastic cuffs, and belt tie, that meets AAMI PB70 Level 3 barrier performance for protective apparel.

This document describes the non-clinical testing performed on the Paneffort AAMI Level 3 Isolation Gown to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Water Resistance (Hydrostatic Pressure): The reported performance shows individual sample failures within each lot (3 out of 32 in Lot 1, 3 out of 32 in Lot 2, and 2 out of 32 in Lot 3). However, the "Conclusion" column for this test still states "The test meets the Acceptance Criteria." This implies that the passing condition is based on an Allowable Quality Level (AQL) or a specific sampling plan where a certain number of defects are permitted within the sample size while still meeting the overall acceptance criteria (Ac: 3, Re: 4; AQL: 4%).

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

• Sample Sizes:
  • Bursting Strength, Basis Weight, Linting Test, Air Permeability, Tensile Strength/Breaking Strength, Tearing Strength, Seam Strength, Flammability, Water Vapour resistance: 32 samples each from 3 different lots (total 96 samples per test).
  • Water Resistance: Hydrostatic Pressure and Impact Penetration: Lot 1: 74 pieces; Lot 2: 72 pieces; Lot 3: 72 pieces (total 218 pieces across 3 lots for each test).
• Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the manufacturer is Paneffort (Cambodia) Garment Co. Ltd., and the specification developer is Paneffort, LLC (USA). The testing standards are international (ASTM, AATCC, ISO, CFR), suggesting tests were conducted in reputable labs, but the specific location of the test facilities is not provided. The data is retrospective, as it was collected to support a 510(k) submission for a device that has already been manufactured and tested.

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

• Not Applicable. This study is a non-clinical performance testing of a physical medical device (isolation gown) against established engineering and material science standards. It does not involve human interpretation of data or diagnostic tasks where expert ground truth would be required. The "ground truth" here is objective measurement against specified criteria.

4. Adjudication Method for the Test Set:

• Not Applicable. As no expert review or human interpretation for diagnosis is involved, there is no adjudication method in the traditional sense. The pass/fail criteria are defined by the testing standards and AQLs.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This submission is for a physical medical device (isolation gown) and does not involve human readers or diagnostic cases.

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

• Not Applicable. This is not an AI/algorithm-based device. It is a physical product. The performance reported is that of the gown itself, as tested in a lab environment.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is based on established industry and regulatory standards for protective apparel. This includes:
  • ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (specifically Level 3).
  • Various ASTM, AATCC, ISO, and CFR standards for material properties and flammability.
  • ISO 10993 for biocompatibility.
• The tests generate objective, measurable data that is compared directly to the numerical acceptance criteria defined in these standards.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set." The performance is inherent to its physical design and materials, verified through non-clinical testing.

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

• Not Applicable. As there is no training set, this question is not relevant.

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