(285 days)
The AAMI4 Isolation Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 Isolation Gown is a single use, disposable medical device provided non-sterile.
The proposed device, AAMI4 Isolation Gown, is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile. There is one model of AAMI4 Isolation Gown: 4015T. And the proposed AAMI4 Isolation Gown is available in one product size: U. The barrier protection level for AAMI4 Isolation Gown meets AAMI Level 4. The proposed device consists of five components: 1) Basic Gown, 2) Belt, 3) Cuff, 4) Hook-and-loop Velcro and 5) Seam Sealing Tape. The gown is made of polypropylene and polyethylene laminating. The gown is blue in color.
The provided document is a 510(k) summary for a medical device called "AAMI4 Isolation Gown." This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving human readers or AI assistance. Therefore, information regarding human readers, AI assistance, effect size, standalone algorithm performance, and sample size for training sets is not available in this document.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Flammability | To evaluate the flammability of the test sample in accordance with 16 CFR Part 1610. | Meets Class 1 requirements | Class 1 |
| Hydrostatic pressure | To determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017. | >50 cm | Gown sleeve: 188 cmH₂O |
| Sleeve seam: 80 cmH₂O | |||
| Body-sleeve seam: 65 cmH₂O | |||
| Gown body: 199 cmH₂O | |||
| Belt attachment: 74 cmH₂O | |||
| Water impact | To determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017. (Note: The purpose description seems to be a typo and should likely refer to water impact.) | ≤1.0 g | Gown sleeve: 0g |
| Sleeve seam: 0g | |||
| Body-sleeve seam: 0g | |||
| Gown body: 0g | |||
| Belt attachment: 0g | |||
| Breaking strength | To evaluate the breaking strength of the test sample in accordance with ASTM D 5034:2009(2017). | >20 N | MD: Mean 87.3 N |
| CD: Mean 66.7 N | |||
| Tearing strength | To evaluate the tearing strength of the test sample in accordance with ASTM D5587:2015(2019). | >20 N | MD: Mean 31.6 N |
| CD: Mean 22.9 N | |||
| Linting | To evaluate the linting of the test sample in accordance with ISO 9073-10:2003. | Log10(particle count) 50 N | Mean 70.9 N |
| Viral barrier (resistance to bacteriophage Phi-X174) | To evaluate the resistance to bacteriophage penetration in accordance with ASTM F1671/F1671M-13. | No bacteriophage penetration | No bacteriophage penetration |
| Cytotoxicity | To evaluate the cytotoxicity of the test sample in accordance with ISO 10993-5 Third edition 2009-06-01. | Viability ≥ 70% of blank; 50% extract viability ≥ 100% extract viability. | The viability was ≥70% of the blank. The 50% extract had higher viability than 100% extract. Proposed device was non-cytotoxic. |
| Sensitization | To evaluate the sensitization of the test sample in accordance with ISO 10993-10 Third Edition 2010-08-01. | Non-sensitizing | The proposed device was non-sensitizing. |
| Irritation | To evaluate the irritation of the test sample in accordance with ISO 10993-10 Third Edition 2010-08-01. | Non-irritating | 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 specify the exact sample sizes for each test. It refers to "test sample" for each methodology. The tests were performed in accordance with international and US standards. The manufacturer is Hubei Xinxin Non-woven Co., Ltd. from Xiantao, Hubei, China. The data provenance is non-clinical laboratory testing; it does not involve human data, thus the terms "retrospective" or "prospective" are not applicable.
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. The ground truth for these non-clinical tests is established by the specified industry and regulatory standards, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical performance and biocompatibility study, not a clinical study requiring human 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
No, an MRMC comparative effectiveness study was not done. This document does not describe studies involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes the testing of a physical medical device (an isolation gown), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the performance tests (Flammability, Hydrostatic pressure, Water impact, Breaking strength, Tearing strength, Linting, Seam strength, Viral barrier) is defined by the technical specifications and requirements within the referenced industry standards (e.g., 16 CFR Part 1610, AATCC 127, ASTM D5034, ISO 9073-10, ASTM D1683/D1683M, ASTM D5587, ASTM F1671/F1671M-13).
The ground truth for the biocompatibility tests (Cytotoxicity, Sensitization, Irritation) is defined by the requirements and methodologies within the ISO 10993 series of standards (ISO 10993-5, ISO 10993-10).
8. The sample size for the training set
Not applicable. This document describes the testing of a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device.
§ 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.