(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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.