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510(k) Data Aggregation
(129 days)
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 surgical gown met the requirements for Level 3 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 devices and are provided in sterile. The surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for surgical gown met AAMI Level 3.
This document describes the non-clinical testing performed for a Surgical Gown (K211809) to demonstrate its equivalence to a predicate device. The information provided heavily focuses on physical and biological performance criteria.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate the flammability of the test sample in accordance with 16 CFR Part 1610. | Meets requirements (implicitly Class 1, as per standard) | Class 1 Pass |
| Hydrostatic Pressure | Determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017. | >50 cm | Average 72.05 cm |
| Water Impact | Evaluate the water impact of the test sample in accordance with AATCC 42: 2017. | ≤1.0 g | Average 0.45g |
| Breaking Strength | Evaluate the breaking strength of the test sample in accordance with ASTM D 5034:2009(2017). | >20N | MD: Average 74.88N CD: Average 50.73N |
| Tearing Strength | Evaluate the tearing strength of the test sample in accordance with ASTM D5587:2015(2019). | >20N | MD: Average 63.87N CD: Average 34.91N |
| Linting | Evaluate the linting of the test sample in accordance with ISO 9073-10:2003. | Log10(particle count) < 4 | Average 3.4 (This implicitly means Log10(particle count) is less than 4) |
| Air Permeability | Evaluate the air permeability of the test sample in accordance with ASTM D737: 2018. | >30 ft³/min/ft² | Average 35.3 ft³/min/ft² |
| EO/ECH Residue (Ethylene Oxide Sterilization Residuals) | Evaluate the level of sterilant residues in accordance with ISO 10993-7:2008. | EO: < 4 mg/device ECH: < 9 mg/device | EO: Average 0.95 mg/device ECH: Average 0.98 mg/device |
| Cytotoxicity | Evaluate the cytotoxicity of the test sample in accordance with ISO 10993-5:2009. | The viability should be ≥ 70% of the blank. And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract. | 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 | Evaluate the sensitization of the test sample in accordance with ISO 10993-10:2010. | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation | Evaluate the irritation of the test sample in accordance with ISO 10993-10:2010. | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each of the non-clinical tests conducted. The provenance of the data is implied to be from the manufacturer's testing, Wuhan Dymex Healthcare Co., Ltd., based in China (Wuhan, China). The tests are prospective, meaning they were conducted specifically for this submission to assess the device's performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. These are non-clinical, laboratory-based tests on a physical product (surgical gown) and do not involve human expert interpretation or ground truth establishment in the way clinical studies with medical imaging or diagnoses would. The "ground truth" is defined by the objective measurement standards of the relevant ASTM, AATCC, ISO, and CFR standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to clinical studies where human interpretation or diagnostic agreement is being assessed. These are objective, standardized laboratory tests.
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 is a submission for a surgical gown, which is a physical medical device, not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. The non-clinical tests are "standalone" in the sense that they evaluate the device's physical and biological properties objectively.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is established by internationally recognized and industry-accepted performance standards (e.g., ANSI/AAMI PB70:2012, 16 CFR Part 1610, AATCC 127, ASTM D5034, ISO 10993 series). The device's performance is measured against the criteria defined within these standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no training set for a physical surgical gown.
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