(90 days)
The Isolation Gown AAMI Level 3 is intended to protect 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 Gown meets 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 Drapes Intended for Use in Health Care Facilities(ANSI/AAMI PB70). The Isolation Gown is single use, disposable medical device provided non-sterile.
Not Found
The provided text is related to the FDA 510(k) clearance for an "Isolation Gown AAMI Level 3" and primarily concerns regulatory approval. It does not describe a study involving a device with AI or software components that would typically have acceptance criteria presented in the requested format.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them, as the provided text pertains to a physical medical device (an isolation gown) and its regulatory clearance based on AAMI Level 3 barrier protection standards, not a software-driven device.
The information I can extract directly related to performance and standards is:
Acceptance Criteria for the Isolation Gown AAMI Level 3:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets 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 Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). | The device is stated to "meet the requirements of an AAMI Level 3 barrier protection". Specific test results (e.g., impact penetration, hydrostatic pressure according to AAMI PB70) are not detailed in this document but are implied to be satisfactory for clearance. |
The provided document does NOT contain information regarding:
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used (beyond implying compliance with AAMI PB70 standards, which often involve laboratory testing for physical properties).
- Sample size for the training set.
- How ground truth for the training set was established.
This is because the cleared device is a physical barrier product, not an AI/software as a medical device (SaMD). The assessment for such devices typically involves laboratory testing against established standards (like AAMI PB70) rather than clinical studies with human readers or AI algorithms.
§ 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.