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ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.

The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.

Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use.

Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks in cuffs, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.

This document describes the acceptance criteria and the study that proves the device (ComfortGuard Plus Surgical Gown, i500 and ComfortGuard Surgical Gown, i500) meets these criteria.

Acceptance Criteria and Device Performance

The acceptance criteria for the surgical gowns are based on their performance as protective apparel, specifically their liquid barrier performance (AAMI PB70 standard) and other physical and safety properties.

Table 1: Acceptance Criteria and Reported Device Performance

Note on Reported Performance: The reported device performance values are the "Mean" results obtained from three lots, as provided in the tables within the document. The values in parenthesis (Min, Max) represent the range of results obtained. The document states that both devices "meet the predetermined specifications" for these physical properties.

Study Proving Device Meets Acceptance Criteria

The provided document is a 510(k) Pre-market Notification for surgical gowns, demonstrating substantial equivalence to a predicate device. The "study" in this context refers to the comprehensive testing conducted to prove that the new devices meet established performance standards (acceptance criteria) and are as safe and effective as a legally marketed predicate device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

(See Table 1 above)

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

• Sample Size: For the AATCC and ASTM tests (Hydrostatic Pressure, Impact Penetration, Grab Tensile, Trapezoid Tear, Seam Strength), the acceptance criteria specify a sample size of n=32 (Acc=3; Rej=4) for the AQL/RQL statistical sampling plan. The test results reported were "obtained from Three Lots".
• Data Provenance: The document does not explicitly state the country of origin where the testing was performed. The applicant, GRI Medical & Electrical Technology Co., Ltd., is located in China, suggesting the data may originate from testing facilities in China or a contracted lab. The data is retrospective, as it represents results from tests already performed to support the 510(k) submission.

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

This type of submission for surgical apparel does not involve clinical studies with human "experts" establishing ground truth in the way a diagnostic AI device would. The "ground truth" for the performance of these surgical gowns is established by adherence to recognized industry standards (AAMI PB70, ASTM, 16 CFR, ISO) and laboratory testing methodologies described within those standards. The expertise lies in the certified labs and technicians performing these specific material and barrier tests. There is no mention of "experts" in the context of clinical interpretation or adjudication.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Performance is measured against objective, quantitative physical and barrier properties according to established industry standards, not subjective expert opinion requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI-assisted ones, where human readers interpret medical images. Surgical gowns are physical barrier devices, and their effectiveness is determined by laboratory performance testing, not human reading of cases. Therefore, there is no effect size reported for human readers improving with AI vs without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product (surgical gown), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" is defined by the objective, quantitative performance requirements of the referenced industry standards:

• AAMI PB70: Liquid barrier performance and classification for protective apparel.
• 16 CFR Part 1610: Flammability standards.
• ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Irritation & Sensitization): Biocompatibility standards.
• ASTM D3776, D5034-09, D5587, D1683: Physical property testing standards (basis weight, tensile strength, tear resistance, seam strength).
• AATCC 127-2014 & AATCC 42-2013: Hydrostatic pressure and impact penetration for liquid barrier.

These standards provide the pre-defined, objectively measurable criteria for performance.

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 "training" for this device would refer to the manufacturing processes and quality control to consistently produce gowns meeting the specifications.

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

Not applicable, as there is no "training set" in the context of AI. For the manufacturing process, the "ground truth" (or target specifications) for quality control and process validation would be established by the engineering and quality teams based on material properties, design requirements, and the performance criteria outlined in the regulatory standards (e.g., AAMI PB70 Level 3).

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