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510(k) Data Aggregation
(95 days)
Disposable Surgical Gown and Disposable Reinforced Surgical Gown are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile. There are two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
The provided FDA 510(k) summary document (K212869) pertains to Disposable Surgical Gowns. This document describes the acceptance criteria and the study that proves the device meets those criteria, specifically through non-clinical performance testing and biocompatibility assessment rather than studies involving AI algorithms or human readers.
Therefore, many of the requested points regarding AI/human reader studies, ground truth establishment for such studies, and multi-reader multi-case analyses are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides extensive tables (Table 3 and Table 4) detailing the acceptance criteria and results for various non-clinical performance and biocompatibility tests.
Table 1: Summary of Performance Testing - Categorized for clarity
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate flammability of the test sample. | Meets Class 1 requirements | Pass |
| Hydrostatic Pressure | Determine hydrostatic pressure. | >50 cm | Level 3 Standard Surgical Gown: Average 67cm; Level 4 Standard Surgical Gown: Average 196cm; Level 4 Reinforced Surgical Gown: Average 162cm |
| Water Impact | Determine hydrostatic pressure. (Note: Description seems to be a typo, likely measuring water penetration/impact resistance) | ≤1.0 g | Level 3 Standard Surgical Gown: Average 0.011g; Level 4 Standard Surgical Gown: Average 0.014g; Level 4 Reinforced Surgical Gown: Average 0.017g |
| Breaking Strength | Evaluate breaking strength. | >20N | Level 3 Standard Surgical Gown: Lat. Avg 96N, Long. Avg 116N; Level 4 Standard Surgical Gown: Lat. Avg 111N, Long. Avg 184N; Level 4 Reinforced Surgical Gown: Lat. Avg 109N, Long. Avg 122N |
| Tearing Strength | Evaluate tearing strength. | >20N | Level 3 Standard Surgical Gown: Lat. Avg 77N, Long. Avg 128N; Level 4 Standard Surgical Gown: Lat. Avg 90N, Long. Avg 137N; Level 4 Reinforced Surgical Gown: Lat. Avg 80N, Long. Avg 137N |
| Linting | Evaluate linting. | Log10(particle count) < 4 | Level 3 Standard Surgical Gown: Average 3.1; Level 4 Standard Surgical Gown: Average 3.0; Level 4 Reinforced Surgical Gown: Average 3.1 |
| Air Permeability | Evaluate air permeability. | >30 ft³/min/ft² | Level 3 Standard Surgical Gown: Average 40 ft³/min/ft² (Note: Only Level 3 reported, but acceptance criteria imply all gowns with this spec meet it) |
| EO/ECH Residue | Evaluate level of sterilant residues. | EO: <4mg/device; ECH: <9mg/device (Specific values also provided for each gown type and residue type: <0.5μg/device) | Level 3 Standard Surgical Gown: EO: <0.5μg/device, ECH: <0.5μg/device; Level 4 Standard Surgical Gown: EO: <0.5μg/device, ECH: <0.5μg/device; Level 4 Reinforced Surgical Gown: EO: <0.5μg/device, ECH: <0.5μg/device (All well within acceptance criteria) |
Table 2: Summary of Biocompatibility Testing
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity | Evaluate cytotoxicity. | Viability ≥ 70% of the blank. 50% extract viability should be ≥ 100% extract viability. | Viability ≥ 70% of the blank. 50% extract viability was higher than 100% extract viability. Device was non-cytotoxic. |
| Sensitization | Evaluate sensitization. | Non-sensitizing | The proposed device was non-sensitizing. |
| Irritation | Evaluate irritation. | Non-irritating | The proposed device was non-irritating. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of units or samples tested for each non-clinical test. However, it indicates that the tests were performed in accordance with various ASTM, ISO, and AATCC standards, which typically specify appropriate sample sizes for such tests.
- Data Provenance: The tests are non-clinical, meaning they are laboratory-based and do not involve patient data. The manufacturer, Fugou County Shenxiang Manufacturing Co., LTD., is located in Henan Province, China. The testing would have been conducted by or overseen by the manufacturer or a third-party testing facility. The data is prospective in the sense that the tests were performed specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission is for surgical gowns, a physical medical device. The "ground truth" for its performance is established through standardized laboratory testing (e.g., barrier properties, strength, flammability) rather than expert consensus on medical images or patient outcomes. The experts involved would be those qualified in materials science, textile engineering, microbiology, and standard compliance, who conduct and interpret the results of these physical and chemical tests.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, the "ground truth" is determined by objective, standardized test protocols, not by expert review or adjudication of subjective interpretations.
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 device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" is defined by objective measurements and performance standards (e.g., ANSI/AAMI PB70:2012, 16 CFR Part 1610, ASTM, and ISO standards) for material properties (hydrostatic pressure, water impact, breaking strength, tearing strength, linting, air permeability) and biological safety (biocompatibility tests like cytotoxicity, irritation, sensitization, and sterilant residues).
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of a physical device like a surgical gown. The product’s design and manufacturing processes are developed to meet the performance criteria, and then tested to confirm compliance.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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