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510(k) Data Aggregation
(209 days)
High protection surgical gown is 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, the high protection surgical gown met the requirements for Level 4 classification.
The proposed device is 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 device is single use, disposable medical device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.
The medical device in question is a High Protection Surgical Gown (product code FYA, regulation number 21 CFR 878.4040, Class II).
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability (16 CFR Part 1610) | Evaluate flammability of the test sample. | Meets requirements | Class 1 |
| Hydrostatic Pressure (AATCC 127) | Determine hydrostatic pressure of the test sample. | ≥50 cm H2O | 204.6 cm H2O |
| Water Impact (AATCC 127) | Determine hydrostatic pressure of the test sample (likely a typo, AATCC 42 is typically for impact penetration). | ≤1.0 g | 0.02g |
| Breaking Strength (ASTM D 5034) | Evaluate breaking strength of the test sample. | ≥30 N | Longitude: 131.5N, Latitude: 75.2N |
| Tearing Strength (ASTM D5587) | Evaluate tearing strength of the test sample. | ≥10 N | Longitude: 79.0N, Latitude: 33.8N |
| Linting (ISO 9073-10) | Evaluate linting of the test sample. | Log10(particle count) < 4 | Side A: 3.1, Side B: 3.2 |
| Seam Strength (ASTM D1683/D1683M) | Evaluate seam strength of the test sample. | ≥30 N | Shoulder Seam: 126.5N, Sleeve Seam: 76.7N, Armhole Seam: 75.3N |
| Resistance against penetration of Phi-X174 bacteriophage (ASTM F 2407-2020) | Evaluate resistance to penetration by blood-borne pathogens. | No detectable transfer of the Phi-X174 Bacteriophage | No detectable transfer of the Phi-X174 Bacteriophage |
| EO/ECH Residue (ISO 10993-7) | Evaluate the level of sterilant residues. | EO: <4mg/device, ECH: <9mg/device | The Method Detection Limit (MDL) of EO residue and ECH residue is 0.093mg/device. The total EO residue and ECH residue of the devices were less than the MDL. |
| Cytotoxicity (ISO 10993-5) | Evaluate cytotoxicity of the test sample. | Viability ≥ 70% of the blank, 50% extract viability ≥ 100% extract viability. | The viability was ≥ 70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. Under the conditions of the study, the proposed device was non-cytotoxic. |
| Sensitization (ISO 10993-10) | Evaluate sensitization of the test sample. | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation (ISO 10993-10) | Evaluate irritation of the test sample. | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gowns tested for flammability or breaking strength). However, the tests are described as being performed "in accordance with" specific international and national standards (e.g., AATCC, ASTM, ISO, CFR). These standards typically prescribe minimum sample sizes for reliable testing.
Data Provenance: The document indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device." Given that the manufacturer is 3A Medical Products Co., Ltd in China, the tests were presumably conducted in China or by labs contracted by the manufacturer. The data is retrospective as it was collected as part of the device development and verification process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. This is a performance and biocompatibility study for a physical medical device (surgical gown), not an AI/software device that requires expert review for ground truth establishment. The "ground truth" for these tests is defined by the objective measurement criteria within the specified standards.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the "ground truth" is based on objective, standardized test methodologies and their defined acceptance criteria, not on human interpretation that would require adjudication.
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
This is not applicable. This document describes the performance testing of a physical medical device (surgical gown) and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes the performance testing of a physical medical device (surgical gown) and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for this study is based on objective, standardized measurement criteria and physical material properties as defined by the referenced national and international standards (e.g., 16 CFR Part 1610 for flammability, AATCC 127 for hydrostatic pressure, ASTM D 5034 for breaking strength, ISO 10993-10 for irritation). These standards provide quantifiable metrics and methodologies against which the device's performance is measured.
8. The Sample Size for the Training Set
This is not applicable. This document describes the performance testing of a physical manufactured product (surgical gown), not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply here.
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