(386 days)
Protective gown AAMI Level 4 is intended to protect health care personnel and patients from transfer of microorganisms, body fluids and particulate material. The Protective Gowns is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
Protective Gown AAMI Level 4
I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Protective Gown AAMI Level 4" does not contain the information required to answer your request about acceptance criteria and a study proving a device meets these criteria.
The document is a regulatory clearance letter for a medical device (a protective gown), and as such, it focuses on the administrative aspects of regulatory approval, such as:
- Device name and product code
- Regulation number and name
- Regulatory class
- Date of submission and receipt
- Determination of substantial equivalence
- General controls provisions and other applicable regulations (e.g., registration, listing, labeling, GMP)
- Contact information for regulatory questions
It does not include details about:
- Acceptance criteria table and reported device performance: This type of information would typically be found in test reports, design specifications, or a summary of safety and effectiveness (SSE) document that supports the 510(k) submission, not the clearance letter itself. For a protective gown, acceptance criteria would likely involve fluid barrier properties (e.g., AAMI Level 4 standards for liquid barrier performance), tensile strength, tear resistance, and other material properties.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study information.
- Standalone (algorithm only) performance information.
- Type of ground truth used.
- Sample size for the training set.
- Method for establishing ground truth for the training set.
These points are highly relevant to studies involving AI/ML medical devices or complex diagnostic/imaging devices, where performance metrics like sensitivity, specificity, AUC, and expert reader studies are crucial. The device in question, a protective gown, is a physical barrier device, and its performance is evaluated through standardized material testing, not typically through human reader studies or AI algorithms.
Therefore, I cannot fulfill your request based on the provided text.
§ 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.