(184 days)
The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) are sterile and non-sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) meets the level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.
Not Found
The provided text describes the regulatory clearance of a surgical gown and does not contain information about the acceptance criteria or a study related to a medical device's performance in terms of accuracy, sensitivity, specificity, or other typical performance metrics for diagnostic or AI-powered devices.
The document states that the "Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) meets the level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities." This indicates that the acceptance criteria for the gown's barrier performance are the Level 3 requirements of ANSI/AAMI PB70:2012. However, the document does not provide the specific reported performance values or details of the study that proves the device meets these criteria. It only asserts that it "meets" them.
Therefore, I cannot fill in the requested table or answer most of the questions as the necessary information is not present in the provided text.
Here's a breakdown of what cannot be extracted from the text:
- 1. A table of acceptance criteria and the reported device performance: The acceptance criterion mentioned is "Level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance." However, the reported device performance against this standard (e.g., specific test results, values for hydrostatic pressure, impact penetration, etc.) is not detailed in the document.
- 2. Sample sized used for the test set and the data provenance: Not applicable as specific performance testing details are not provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 document is about surgical gowns, not an AI-powered diagnostic device or an AI assistance system.
- 6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a surgical gown would be its physical barrier properties as measured by standardized tests.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The document focuses on the regulatory clearance process for a medical device (surgical gowns) based on its compliance with established industry standards for barrier performance (ANSI/AAMI PB70:2012 Level 3) and sterilization validation (ethylene oxide process according to ISO 11135-1). It does not delve into the detailed results of the tests performed to demonstrate this compliance.
§ 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.