(118 days)
Cardinal Health SmartGown™ surgical gown is 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. The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device provided sterile and non-sterile.
The Cardinal Health SmartGown™ surgical gowns are constructed of a multi-layer construction of a nonwoven outer layer, breathable film core and a nonwoven inner layer and have been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health care Facilities. The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations. This submission covers 12 models of Cardinal Health SmartGown surgical gowns, see Table 1 below.
This document describes the testing and acceptance criteria for the Cardinal Health SmartGown™ surgical gown. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Cardinal Health SmartGown™ surgical gown are established by various ASTM and AATCC standards, as well as the AAMI PB70:2012 Level 4 requirements. The reported device performance confirms that the gowns meet or exceed these criteria.
| Feature / Test | Acceptance Criteria | Reported Device Performance (Mean, Min/Max) - Body | Reported Device Performance (Mean, Min/Max) - Sleeve | Reported Device Performance (Mean, Min/Max) - Back Panel |
|---|---|---|---|---|
| Physical Properties (Critical Zones - Body & Sleeve) | ||||
| ASTM D3776 Basis Weight (gsm) | Body: 50.9 Mean min; Sleeve: 65.1 Mean min | Body: 52.1 (51.3 / 53.1) | Sleeve: 69.6 (69.0 / 70.3) | N/A (Not a critical zone for this test) |
| ASTM D5034 Grab Tensile CD (lb) | Body: 14.4 Mean min; Sleeve: 18.0 Mean min | Body: 17.8 (15.9 / 20.0) | Sleeve: 23.9 (21.9 / 26.0) | N/A |
| ASTM D5733 Trap Tear Peak MD (lb) | Body: 4.0 Mean min; Sleeve: 5.4 Mean min | Body: 5.6 (4.4 / 6.8) | Sleeve: 7.7 (6.0 / 9.9) | N/A |
| ASTM D5733 Trap Tear Peak CD (lb) | N/A (MD Trap tear is limiting specification value) | Body: 8.9 (6.9 / 10.4) | Sleeve: 10.7 (9.0 / 12.5) | N/A |
| ASTM D774 Mullen Burst (psi) | Body: 30.0 Mean min; Sleeve: 36.9 Mean min | Body: 34.3 (31.2 / 37.9) | Sleeve: 45.1 (39.5 / 49.4) | N/A |
| ASTM E96 WVTR, 23°C, 50%RH (g/m²/24hours) | Body: 740 Mean min; Sleeve: 708 Mean min | Body: 822 (752 / 866) | Sleeve: 764 (724 / 814) | N/A |
| ASTM E96 WVTR, 27°C, 50%RH (g/m²/24hours) | Body: 931 Mean min; Sleeve: 833 Mean min | Body: 983 (951 / 1022) | Sleeve: 918 (876 / 983) | N/A |
| ASTM E96 WVTR, 32°C, 50%RH (g/m²/24hours) | Body: 1191 Mean min; Sleeve: 1117 Mean min | Body: 1439 (1323 / 1618) | Sleeve: 1251 (1185 / 1426) | N/A |
| 16 CFR Part 1610 Flammability | Body: Class 1; Sleeve: Class 1 | Body: Class 1 | Sleeve: Class 1 | Back Panel: Class 1 |
| AAMI PB70 Barrier Performance Level | Body: Level 4; Sleeve: Level 4 | Body: Level 4 | Sleeve: Level 4 | N/A (Back panel is Level 3 for specialty gown) |
| Physical Properties (Non-Critical Zone - SMS Back panel) | ||||
| ASTM D3776 Basis Weight (gsm) | Back Panel: 31.5 Mean min | N/A | N/A | Back Panel: 34.6 (33.4/35.8) |
| AATCC-42 Water Impact (g) | Back Panel: 0.5 Mean max | N/A | N/A | Back Panel: 0.12 (0.08/0.20) |
| ASTM D5034 Grab Tensile CD (lb) | Back Panel: 10.0 Mean min | N/A | N/A | Back Panel: 12.5 (9.2/14.8) |
| ASTM D5733 Trap Tear Peak MD (lb) | Back Panel: 3.0 Mean min | N/A | N/A | Back Panel: 3.7 (2.8/5.1) |
| AATCC 127 Hydrostatic Head (cm) | Back Panel: 50 Mean min | N/A | N/A | Back Panel: 69.0 (50.7/78.7) |
| Liquid Barrier Performance Classification Properties | ||||
| ASTM F1671/F1671M-13 (Level 4 compliance) | AAMI PB70:2012 Level 4 requirements | Pass | Pass | Pass (for critical zones) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For almost all tests (Basis Weight, Grab Tensile, Mullen Burst, WVTR, Flammability, Trap Tear, Water Impact, Hydrostatic Pressure, ASTM F1670, ASTM F1671), the sample size used was n=32.
- Data Provenance: The document does not specify the country of origin of the data. However, it indicates that the tests were performed on "Final finished goods, that were twice EO sterilized (Cardinal Health SmartGown™ surgical gown)". This suggests the data is prospective as it's from testing the manufactured device against established performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is a medical device (surgical gown) performance testing, not a diagnostic AI study. Therefore, there are no human experts establishing "ground truth" in the traditional sense of medical image interpretation or clinical diagnosis. The "ground truth" here is the adherence to established internationally recognized material testing standards and regulatory guidance (ASTM, AATCC, AAMI PB70:2012, FDA Guidance). The experts involved would be the testing laboratories and their personnel following these standard protocols. The document does not specify their individual qualifications beyond executing the tests according to the standards.
4. Adjudication Method for the Test Set
Not applicable. As this is not a study involving human interpretation or clinical outcomes, there is no adjudication method in the context of resolving differing expert opinions. The outcome of each test is a direct measurement or observation against a predefined standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI-powered diagnostic or assistive device. It is a surgical gown, and its performance is evaluated through standardized physical and barrier protection tests, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm or AI. It is a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for this device's acceptance is based on established material testing standards and regulatory performance classifications:
- ASTM International Standards: Various ASTM standards (e.g., D3776, D5034, D5733, D774, E96, F1670, F1671) define the methods for testing physical properties and barrier resistance.
- AATCC Standards: AATCC standards (e.g., 42, 127) define methods for water resistance.
- AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes: This standard sets the performance levels for surgical apparel, with the device aiming for Level 4.
- 16 CFR Part 1610 (Flammability): A regulatory standard for flammability.
The device's performance is compared directly against the specified requirements within these standards.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through empirical testing against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.