(106 days)
The Surgical Isolation Cover Gown is intended to protect health care persomel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.
The proposed device is 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. The proposed device is a single use, disposable medical device provided non-sterile. The proposed device is available in nine sizes, including XS, S, M, L, XL, 2XL, 3XL, 4XL, 5XL. The barrier protection level for Surgical Isolation Cover Gown meets AAMI Level 3. The proposed device is provided in yellow.
The provided document is a 510(k) premarket notification for a medical device, specifically a "Surgical Isolation Cover Gown." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or diagnostic accuracy for an AI/ML powered device.
Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and effect sizes) is not applicable to this document. This document details the physical and biological performance characteristics of a protective garment.
However, I can extract the acceptance criteria and reported device performance from the provided tables, as well as information about the testing methodology for this type of medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate the flammability of the test sample in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles. | Meets Class 1 requirements | Class 1 |
| Hydrostatic Pressure | Determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test. | >50 cm H2O | Mean = 70.63 cm H2O (Max = 72.33 cm H2O, Min = 68.88 cm H2O) |
| Water Impact | Determine the water impact of the test sample in accordance with AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test. | ≤1.0 g | Mean = 0.58 g (Max = 0.69 g, Min = 0.49 g) |
| Breaking Strength | Evaluate the breaking strength of the test sample in accordance with ASTM D 5034:2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test). | >20 N | MD: Mean = 74.82 N (Max = 79.64 N, Min = 70.43 N) |
| CD: Mean = 49.35 N (Max = 55.18 N, Min = 40.96 N) | |||
| Tearing Strength | Evaluate the tearing strength of the test sample in accordance with ASTM D5587:2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure. | >20 N | MD: Mean = 62.92 N (Max = 69.72 N, Min = 62.01 N) |
| CD: Mean = 32.57 N (Max = 34.99 N, Min = 30.05 N) | |||
| Linting | Evaluate the linting of the test sample in accordance with ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State. | Log10(particle count) 50 N | Mean = 102.92 N (Max = 109.98 N, Min = 95.37 N) |
| Air Permeability | Evaluate the air permeability of the test sample in accordance with ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics. | >30 ft³/min/ft² | Mean 35.4 ft³/min/ft² |
| Cytotoxicity | Evaluate the cytotoxicity of the test sample in accordance with ISO 10993-5:2009. | Viability $\ge$ 70% of the blank. 50% extract should have $\ge$ 100% extract viability. | Viability $\ge$ 70% of the blank. 50% extract had higher viability than 100% extract. Non-cytotoxic. |
| Sensitization | Evaluate the sensitization of the test sample in accordance with ISO 10993-10:2010. | Non-sensitizing | Non-sensitizing. |
| Irritation | Evaluate the irritation of the test sample in accordance with ISO 10993-10:2010. | Non-irritating | Non-irritating. |
| Barrier Protection Level | - | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted according to recognized international and national standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the number of individual garments or test specimens used for each particular test (e.g., how many samples were used to calculate the mean Hydrostatic Pressure). However, standard testing protocols for these types of materials and products typically involve multiple specimens to ensure representative results.
- Data Provenance: The device manufacturer is "Wuhan Dymex Healthcare Co., Ltd." in Wuhan, China. The tests are reported to have been performed in accordance with international (ISO, AATCC) and national (ASTM, 16 CFR) standards. The nature of these tests (material properties) suggests they are prospective tests performed on manufactured samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical and biological performance testing of a medical device (a gown), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling (e.g., for images or clinical data). The "ground truth" for these tests comes from the physical/chemical measurements themselves against defined standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, there's no need for expert adjudication in these types of performance tests. The results are quantitative measurements against predefined physical/chemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not an AI/ML or diagnostic imaging device. MRMC studies are used to evaluate the impact of a new technology (e.g., AI assistance) on human reader performance, which is not relevant for a surgical isolation gown.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device. The "standalone" performance here refers to the gown's inherent physical and biological barrier properties, which were measured directly through the non-clinical tests.
7. The Type of Ground Truth Used:
- For physical properties (e.g., hydrostatic pressure, breaking strength, linting), the "ground truth" is established by direct measurement of the material and product characteristics against the specifications outlined in the referenced standards (e.g., ANSI/AAMI PB70, ASTM, AATCC, ISO).
- For biocompatibility (cytotoxicity, sensitization, irritation), the "ground truth" is established through laboratory testing against the criteria specified in ISO 10993 (e.g., cell viability percentages, absence of specific reactions).
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an AI/ML device that requires machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As per point 8, there is no training set for this type of medical device 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.