(154 days)
Surgical Gowns 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.
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This document explicitly states that the submission is for a "Surgical Gown" and is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring formal clinical studies with acceptance criteria and ground truth in the way medical imaging or diagnostic AI devices do.
Therefore, the provided text does not contain information about:
- A table of acceptance criteria and the reported device performance: This is not applicable to a 510(k) for a surgical gown in the context of clinical performance metrics. The relevant acceptance criteria for a surgical gown would typically involve performance standards outlined in recognized standards (e.g., AAMI PB70 for liquid barrier performance or ASTM F1670 for synthetic blood penetration), and these results would be presented in a different format than a clinical study's performance table.
- Sample size used for the test set and the data provenance: Not applicable for this type of device and submission. Performance tests for gowns would involve material samples, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for algorithm performance (e.g., expert consensus on medical images) is not relevant here. Performance is measured against physical standards.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for assessing diagnostic performance with and without AI assistance, which is outside the scope of a surgical gown.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm device.
- The type of ground truth used: Not applicable in the context of clinical/diagnostic ground truth; performance is measured against physical material standards.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
The "study" in this context refers to the testing performed against recognized standards to demonstrate the physical performance characteristics of the surgical gown, such as barrier effectiveness, strength, and breathability. The provided document is simply the FDA's clearance letter and the "Indications for Use" statement, not the detailed testing report itself.
To answer your request, if this were an AI device, the FDA submission would contain a separate section detailing the clinical performance study, including the elements you listed. Since this is a surgical gown, the "performance" discussed in such a 510(k) would be related to how well the gown meets established material and barrier standards, and the "study" would be the associated lab testing.
§ 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.