(128 days)
The 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. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical non-sterile.
The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations.
The provided text describes the acceptance criteria and the results of non-clinical tests for an Isolation Gown. This is a medical device, specifically protective apparel, and not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this document.
Here's the relevant information based on the provided text for the Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)):
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria for Level 3 Barrier | Result of Yellow Isolation Gown XXL | Result of Blue Isolation Gown XXL |
|---|---|---|---|---|
| Water Resistance: Hydrostatic Pressure Test | AATCC 127-2018e | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | Passed | Passed |
| Water Resistance: Impact Penetration Test | AATCC 42-2017 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | Passed | Passed |
| Breaking Strength and Elongation | ASTM D 5034-2009 (2017) | ≥30N(7lbf) | Passed | Passed |
| Tearing Strength | ASTM D 5587-2015 | ≥10N (2.3 lbf) | Passed | Passed |
| Seam Strength | ASTM D1683/D1683M-2017 (2018) | ≥30N (7lbf) | Passed | Passed |
| Lint and other particles generation in the dry state | ISO 9073-10:2003 | Reported Data | Total linting: Avg 187; Coeff of linting: Avg 2.3 | Total linting: Avg 584; Coeff of linting: Avg 2.8 |
| Thermal and Evaporative Resistance | ASTM F 1868-2017 | Reported Data | Evaporative resistance: 0.00217 | Evaporative resistance: 0.00198 |
| Flammability Test | 16 CFR Part 1610 | Class I | Passed | Passed |
| Mass Per Unit Area | ISO 9073-1:1989 | Reported Data | 39.56 | 40.62 |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility: Sensitization | ISO 10993-10 | Non-sensitizing | Non-sensitizing | Non-sensitizing |
| Biocompatibility: Irritation | ISO 10993-10 | Negligibly irritating | Negligibly irritating | Negligibly irritating |
2. Sample sized 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 specific test but indicates that tests were performed on "Yellow Isolation Gown XXL" and "Blue Isolation Gown XXL". The tests are non-clinical, related to material properties of the gown. Data provenance (country of origin, retrospective/prospective) is not provided as this is an evaluation of a physical medical device, not a data-driven model.
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. This is a physical medical device (isolation gown), not an AI/ML device relying on expert interpretation for ground truth. Ground truth is established by physical and chemical testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical medical device, not an AI/ML device requiring adjudication of results.
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 physical medical device, 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 a physical medical device, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is based on established international and national standards for performance and safety of protective apparel and medical devices. Specifically:
- ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities (for liquid barrier performance)
- AATCC 127-2018e (Water Resistance: Hydrostatic Pressure Test)
- AATCC 42-2017 (Water Resistance: Impact Penetration Test)
- ASTM D 5034-2009 (2017) (Breaking Strength and Elongation)
- ASTM D 5587-2015 (Tearing Strength)
- ASTM D1683/D1683M-2017 (2018) (Seam Strength)
- ISO 9073-10:2003 (Lint and other particles generation)
- ASTM F 1868-2017 (Thermal and Evaporative Resistance)
- 16 CFR Part 1610 (Flammability Test)
- ISO 9073-1:1989 (Mass Per Unit Area)
- ISO 10993-1:2018, ISO 10993-5, ISO 10993-10 (Biocompatibility)
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set with established ground truth.
§ 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.