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510(k) Data Aggregation
(104 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 Gowns meet 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 non-sterile.
Disposable Isolation Gowns are designed for the medical personnel using 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 sleeve and body of 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 single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL.
The provided text describes the acceptance criteria and performance data for a medical device, specifically Disposable Isolation Gowns. However, it is not an AI/ML powered medical device. Therefore, the requested information pertaining to AI/ML model performance, such as sample sizes for test sets, data provenance, expert consensus for ground truth, MRMC studies, or training set details, is not applicable to this document.
The document focuses on demonstrating the substantial equivalence of the proposed isolation gowns to a legally marketed predicate device based on their physical properties, barrier performance, and biocompatibility.
Here's the relevant information that can be extracted, presented in the requested format where applicable:
Acceptance Criteria and Reported Device Performance for Disposable Isolation Gowns
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Performance Tests | ||
| Seam strength | $\ge$ 30N (7lbf) per standard F2407-20 | Pass |
| Breaking strength | $\ge$ 30N (7lbf) per standard F2407-20 | Pass (Mean Result MD: 85.6N, CD: 77.3 N) |
| Tear strength (N) | $\ge$ 20N | Pass (Mean Result MD: 29.9N, CD: 18.43N) |
| Lint and other particle generation in dry state | Critical area $\le$ 4.0, Less critical area $\le$ 4.0 | Pass |
| Flammability | Class I per 16 CFR Part 1610 | Pass |
| Liquid Barrier Performance Tests (AAMI Level 3) | ||
| Water proof property (material, seam) | $\le$ 1.0g AQL: 4%, Level 3 per standard ANSI/AAMI PB70:2012 (AATCC42-2017) | Pass |
| Static hydrostatic resistance | $\ge$ 50 cmH2O per standard ANSI/AAMI PB70:2012 (AATCC 127-2018) | Pass |
| Biocompatibility Endpoints Assessment | ||
| Cytotoxicity | Non-Cytotoxic | PASS |
| Irritation | Non-Irritating | PASS |
| Sensitization | Non-Sensitizing | PASS |
Points 2-9 are not applicable as this is not an AI/ML medical device submission.
- 2. Sample size used for the test set and the data provenance: Not applicable. The tests are for physical and biological properties of the gowns, not an AI/ML model. The testing is based on standard methods for material properties. The provenance is internal testing by the manufacturer (Xiamen Probtain Medical Technology Co., Ltd. in China).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical and biological tests is defined by established international standards (ISO, ASTM, AATCC, CPSC).
- 4. Adjudication method for the test set: Not applicable. Results are quantitative measurements against defined criteria.
- 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 not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- 7. The type of ground truth used: For physical and barrier performance, the "ground truth" is defined by the acceptance criteria specified in the referenced industry standards (e.g., AAMI PB70:2012, ASTM, ISO, AATCC, CPSC 16 CFR). For biocompatibility, it's the biological response observed under standardized test conditions (e.g., non-cytotoxic, non-irritating, non-sensitizing).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary: The provided document is a 510(k) submission for a non-AI/ML medical device (disposable isolation gowns). The "study" proving the device meets acceptance criteria consists of a battery of non-clinical, laboratory-based tests of the product's physical, barrier, and biocompatibility properties, demonstrating compliance with recognized standards. The concept of an "AI/ML model" and associated metrics (training/test sets, human readers, ground truth creation for AI) does not apply to this submission.
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(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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