(121 days)
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardin™ SMARTGOWN™ AIR Breathable Surgical Gown 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. The gowns meet the barrier protection requirements of AAMI Level 4 per 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™ Breathable Surgical Gown and Cardinal Health™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.
The provided text is a 510(k) premarket notification for surgical gowns, which are physical medical devices. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device through performance testing of the physical properties and barrier protection of the gowns.
Therefore, the concepts of acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training sets are not applicable in the context of this document. These concepts are relevant to the evaluation of AI/ML-driven software as a medical device (SaMD) or devices that incorporate such software, which rely on data analysis and interpretation.
The document describes the performance criteria for the surgical gowns, which are based on physical barrier protection standards.
Here's the relevant information from the document related to "acceptance criteria" and "device performance":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. | The gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not detailed in the provided document. The 510(k) summary (which is typically a separate document) or the full submission would contain details about the specific tests performed (e.g., synthetic blood penetration, hydrostatic pressure, impact penetration) and the number of samples tested to demonstrate AAMI Level 4 compliance. This involves physical testing of the gowns, not analysis of medical image data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth for surgical gowns is established through standardized laboratory testing protocols, not by expert medical interpretation.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is relevant for diagnostic or interpretive AI/ML devices.
6. Standalone Performance Study
Not applicable in the context of a physical surgical gown. The "standalone performance" of the gown refers to its ability to meet the AAMI Level 4 barrier standards independently, which is what the submission attests to.
7. Type of Ground Truth Used
The "ground truth" for surgical gowns is defined by the objective, quantifiable results of standardized physical tests according to AAMI PB70:2012. This involves tests for fluid resistance, microbial barrier properties, etc.
8. Sample Size for the Training Set
Not applicable. Surgical gowns are physical devices; there is no "training set" in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.