(105 days)
The ComfortGuard Surgical Gown, i600, Film Reinforced is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) consists of a multi-layer in the critical zones (SMS & Film Lamination), single layer of SMS (polyolefin nonwoven) in the noncritical zones in the body and sleeve, single layer of SMS (polyolefin nonwoven) in the back panel with a lower basis weight SMS.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) is provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight regular sizes and two special sizes (A-frame) available for each design in both sterile and nonsterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, XXL-XLONG, Aframe L-XLONG, A-frame XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. And the reinforcement still covers the critical zone as in the other product codes.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) has been tested according to AAMI PB70:2012 and met the AAMI Level 4 liquid barrier performance requirements. It is constructed with or without thumb-hooks 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.
Here's a breakdown of the acceptance criteria and study information for the ComfortGuard Surgical Gown, i600, Film Reinforced, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the AAMI PB70 standard for liquid barrier performance, along with other ASTM and ISO standards for physical properties and biocompatibility.
| Test / Performance Metric | Acceptance Criteria | Reported Device Performance (ComfortGuard Surgical Gown, i600, Film Reinforced) |
|---|---|---|
| AAMI PB70 & ASTM F1671-13 Viral Penetration (Critical Zones) - Level 4 Requirements | A1: Base Material: Pass | |
| A2: Tie Attachment: Pass | ||
| B1: Lower Sleeve Seam: Pass | ||
| B2: Upper Sleeve Seam: Pass | ||
| AQL=4% (α=.05) | ||
| RQL=20% (β=0.10) | ||
| n=32; Acc=3; Rej=4 | A1: Base Material: PASS | |
| A2: Tie Attachment: PASS | ||
| B1: Lower Sleeve Seam: PASS | ||
| B2: Upper Sleeve Seam: PASS | ||
| (Results obtained from three independent Lots) (Implicitly meets AQL/RQL given "PASS" results) | ||
| AATCC 42-2013 Impact Penetration (Non-Critical Zone) - Level 1 Requirements | C1: Base Material: ≤4.5g | |
| C2: Sleeve Joint Sewn Seam: ≤4.5g | ||
| C3: Sleeve Seam: ≤4.5g | ||
| AQL=4% (α=.05) | ||
| RQL=20% (β=0.10) | ||
| n=32; Acc=3; Rej=4 | C1: Base Material: 0.03grams (0.00, 0.08) | |
| C2: Sleeve Joint Sewn Seam: 2.26grams (0.07, 4.42) | ||
| C3: Sleeve Seam: 0.00grams (0.00, 0.05) | ||
| (Results obtained from three Lots) (Implicitly meets AQL/RQL given numerical results are well below the criteria) | ||
| AATCC 42-2013 Impact Penetration (Non-Critical Zone - Back) - Level 1 Requirements | D1: Base Material: ≤4.5g | |
| D2: Back Joint Sewn Seam: ≤4.5g | ||
| D3: Back Tie Attachment: ≤4.5g | ||
| AQL=4% (α=.05) | ||
| RQL=20% (β=0.10) | ||
| n=32; Acc=3; Rej=4 | D1: Back- Base Material: 1.00grams (0.07, 4.31) | |
| D2: Back Joint Sewn Seam: 2.54grams (0.21, 4.48) | ||
| D3: Back Tie Attachment: 0.89grams (0.00, 4.47) | ||
| (Results obtained from three Lots) (Implicitly meets AQL/RQL given numerical results are well below the criteria) | ||
| 16 CFR Part 1610 (2014) Flammability | Meets Class 1 requirement | Tested and met Class 1 requirement |
| Biocompatibility (ISO 10993-5 and ISO 10993-10) | Device is non-cytotoxic, non-sensitizing, and non-irritating | Under the conditions of each study, the device is non-cytotoxic, non-sensitizing and non-irritating (Passed all tests). |
| ASTM D3776 (2009) Basis Weight (gsm) | Critical zone - Body/Sleeve Material: Mean =102gsm (-10, +10) | |
| Non-Critical zone- Body/Sleeve Material: Mean =47gsm (-5, +5) | ||
| Back Material: Mean =33gsm (-3, +3) | Critical zone - Body/Sleeve Material: 109.5gsm (103.0, 118.0) | |
| Non-Critical zone- Body/Sleeve Material: 49.3gsm (47.0, 52.0) | ||
| Back Material: 33.9gsm (32.0, 36.0) | ||
| (Results obtained from Three Lots) (All reported mean values are within the specified ranges) | ||
| ASTM D5034-09 (2013) Grab Tensile (Newton) | Critical Zone Body/Sleeve Material MD: Mean MD ≥ 100N | |
| Critical Zone Body/Sleeve Material CD: Mean CD ≥ 70N | ||
| Non-Critical Zone Body/Sleeve Material MD: Mean MD ≥ 40N | ||
| Non-Critical Zone Body/Sleeve Material CD: Mean CD ≥ 20N | ||
| Back Material MD: Mean MD ≥ 40N | ||
| Back Material CD: Mean CD ≥ 20N | Critical Zone Body/Sleeve Material MD: 170.0N (151.6, 186.7) | |
| Critical Zone Body/Sleeve Material CD: 141.5N (115.4, 166.8) | ||
| Non-Critical Zone Body/Sleeve Material MD: 95.9N (85.2, 107.9) | ||
| Non-Critical Zone Body/Sleeve Material CD: 61.3N (53.4, 70.9) | ||
| Back Material MD: 82.6N (62.5, 101.5) | ||
| Back Material CD: 56.7N (43.1, 67.2) | ||
| (Results obtained from Three Lots) (All reported mean values are well above the minimum required) | ||
| ASTM D5587 (2014) Trapezoid Tear (Newton) | Critical Zone Body/Sleeve Material MD: Mean MD ≥ 20N | |
| Critical Zone Body/Sleeve Material CD: Mean CD ≥ 40N | ||
| Non-Critical Zone Body/Sleeve Material MD: Mean MD ≥ 10N | ||
| Non-Critical Zone Body/Sleeve Material CD: Mean CD ≥ 20N | ||
| Back Material MD: Mean MD ≥ 10N | ||
| Back Material CD: Mean CD ≥ 20N | Critical Zone Body/Sleeve Material MD: 57.3N (42.8, 73.2) | |
| Critical Zone Body/Sleeve Material CD: 75.0N (62.1, 88.3) | ||
| Non-Critical Zone Body/Sleeve Material MD: 16.5N (13.2, 21.4) | ||
| Non-Critical Zone Body/Sleeve Material CD: 25.4N (20.9, 34.9) | ||
| Back Material MD: 20.7N (14.4, 28.4) | ||
| Back Material CD: 33.3N (24.9, 46.1) | ||
| (Results obtained from Three Lots) (All reported mean values are above the minimum required) | ||
| ASTM D1683 (2007) Seam Strength (Newton) | Outer Sleeve seam: Min ≥20 N | |
| Inner Sleeve seam: Min ≥50 N | Outer Sleeve Seam: 47.4N (21.0, 60.2) | |
| Inner Sleeve Seam: 90.4N (75.2, 106.0) | ||
| (Results obtained from Three Lots) (Both reported min values meet or exceed the minimum required) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size:
- For the AAMI PB70 / ASTM F1671-13 (Viral Penetration) and AATCC 42-2013 (Impact Penetration) tests, the specified sample size is n=32 for each critical zone/material type, with an acceptance quality limit (AQL) of 4% and a rejection quality limit (RQL) of 20%.
- For the physical property tests (Basis Weight, Grab Tensile, Trapezoid Tear, Seam Strength), results are reported as "Results obtained from Three Lots" for Mean (Min, Max). The specific sample size per lot for these tests is not explicitly stated, but implies multiple samples were taken across these three lots.
- Data Provenance:
- The document does not explicitly state the country of origin of the data for these performance tests. Given that the manufacturer is "GRI Medical & Electronic Technology Co., Ltd." located in JiaXing, China, it is plausible the testing was performed in China or by labs contracted by the manufacturer.
- The studies described are prospective in nature, as they involve testing the manufactured device according to specific standards to determine its performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This document describes performance testing of a physical medical device (surgical gown) against recognized industry standards (AAMI PB70, ASTM, ISO).
- No human experts are used to establish "ground truth" in the context of diagnostic performance (e.g., radiologists interpreting images). Instead, the "ground truth" is established by the standardized testing methodologies themselves, which provide objective, measurable results (e.g., pass/fail for viral penetration, grams for impact penetration, Newtons for tensile strength).
- The "experts" involved would be the certified laboratory technicians performing these tests, who are qualified to conduct tests according to the specified ASTM/ISO/AAMI standards. Their specific qualifications (e.g., years of experience) are not detailed in this summary.
4. Adjudication Method for the Test Set
- None. As explained above, the tests are objective, quantifiable physical and barrier performance assessments governed by specific standards. The results are not subject to human interpretation or adjudication in the way that, for example, diagnostic image reviews would be. The acceptance/rejection criteria are pre-defined by the AQL/RQL and specific performance thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on clinical decision-making. This document describes the performance of a surgical gown, which is a physical barrier device, not a diagnostic tool requiring human interpretation.
6. If a Standalone (algorithm only without human-in-the loop performance) was done
- Not applicable. This question pertains to AI-powered diagnostic algorithms. The ComfortGuard Surgical Gown is a physical medical device; there is no "algorithm" or "human-in-the-loop" aspect to its performance evaluation beyond standard quality control and testing procedures for manufactured goods.
7. The Type of Ground Truth Used
- The "ground truth" for the performance of the surgical gown is established by objective, quantitative measurements performed according to internationally recognized standards and specifications. These include:
- Standardized Test Results for Barrier Performance: Meeting "Pass" criteria for viral penetration (ASTM F1671-13) and having impact penetration values below specified thresholds (AATCC 42-2013), as outlined in AAMI PB70.
- Standardized Test Results for Physical Properties: Meeting or exceeding specified minimums or ranges for Basis Weight (ASTM D3776), Grab Tensile (ASTM D5034-09), Trapezoid Tear (ASTM D5587), and Seam Strength (ASTM D1683).
- Biocompatibility Testing: Demonstrating non-cytotoxicity, non-sensitization, and non-irritation as per ISO 10993-5 and ISO 10993-10.
- Flammability Testing: Meeting Class 1 requirements as per 16 CFR Part 1610 (2014).
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI model. Therefore, there is no "training set" in the machine learning sense. The manufacturing process is implicitly "trained" through process controls and quality management, but not data-driven machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.