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510(k) Data Aggregation
(56 days)
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile.
Disposable Isolation Gowns are designed for the medical personnel use in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL
The provided document describes the acceptance criteria and the results of non-clinical tests for the "Disposable Isolation Gowns" (K223411) from Xiamen Probtain Medical Technology Co., Ltd.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam strength | ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics. | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (89.86 N, average from 10 samples) |
| Breaking strength | ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 90.92 N, CD: 77.06 N, average from 10 samples) |
| Tear strength (N) | ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure | ≥10N | PASS (MD: 31.89 N, CD: 19.2 N, average from 10 samples) |
| Lint and other generation in the dry state | ISO 9073-10: 2003 Textiles - Test Methods for Nonwovens - Part 10: Lint and Other Particles Generation in the Dry State | Log10(particle count) < 4 | PASS (1.8, average from 10 samples) |
| Flammability | CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles | Class I | PASS (Class I) |
| Water Penetration Resistance | AATCC 42-2013, Impact Penetration Test | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≤1.0g) |
| Static hydrostatic resistance | AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≥50 cmH2O) |
| EO and ECH sterilization residual | ISO 10993-7:2008 Ethylene oxide sterilization residuals | EO ≤ 4mg/d, ECH ≤ 9mg/d | PASS (EO ≤ 4mg/d, ECH ≤ 9mg/d) |
| Biocompatibility: Cytotoxicity | ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity (The test was performed under the conditions of the study, the device extract was not cytotoxic.) | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic.) |
| Biocompatibility: Irritation | ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization (The test was performed under the conditions of the study, the non-polar and polar device extracts were not found to be an irritant.) | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating.) |
| Biocompatibility: Sensitization | ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization (Under conditions of the study, the non-polar and polar device extracts were not found to be a sensitizer.) | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Mechanical/Physical Tests: For most mechanical and physical tests (Seam strength, Breaking strength, Tear strength, Lint and other generation), the results are reported as an "Average result from 10 samples."
- Sample Size for Biocompatibility Tests: Not explicitly stated but generally follows ISO 10993 standards which define sample sizes.
- Data Provenance: The tests were conducted to verify that the proposed device met design specifications. The document does not specify the country of origin of the testing data beyond listing the applicant's address in Xiamen, Fujian, China. The studies are non-clinical (laboratory-based performance and safety tests), not related to patient data, so "retrospective or prospective" does not apply in the typical sense.
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)
This product is a medical device (isolation gown), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests is established by adherence to recognized international and national standards (e.g., AAMI, ASTM, ISO, CPSC). The experts involved would be laboratory technicians and engineers who are qualified to perform these specific standard tests, but their specific number or qualifications are not detailed in this submission as it's not relevant for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically for clinical studies or studies involving human readers/interpreters. This document describes non-clinical laboratory testing of a physical product against established performance standards. Therefore, an adjudication method is not applicable and not mentioned.
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
No, an MRMC comparative effectiveness study was not done. This device is a disposable isolation gown, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This is not an algorithmic device. The "standalone" performance here refers to the physical gown's performance against defined standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is defined by the acceptance criteria specified in recognized industry standards (e.g., AAMI PB70:2012, ASTM D1683M-17, ISO 10993). Therefore, it's a standards-based ground truth.
8. The sample size for the training set
This is a physical medical device (isolation gown) undergoing non-clinical performance and biological safety testing, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.
9. How the ground truth for the training set was established
As explained in point 8, there is no training set for this type of device.
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