(281 days)
ComPel MLR Surgical gowns are medical devices that are intended to be worn by operating room personnel to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.
Surgical gowns may provide different levels of protection dependent upon the fabric materials used and the placement of such materials in the final design of the gown.
When processed according to instructions, ComPel MLR Surgical gowns will function and perform as a barrier through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns and are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
All fabric components used in ComPel® 3000 Surgical Gowns are made from 100% polyester, solution luble outer for the outer ComPel 3000 layer and non-dyed filaments with carbon yarns for the inner layer, and are treated with a fluorochemical finish.
ComPel® 3000 Surgical Gowns will function as a surgical attire when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
ComPel® 3000 Surgical Gowns are intended to be worn by personnel functioning in the surgical theater and will be put in all critical areas of the product where liquid protection is needed. The liquid barrier properties with minon the migrated "inverted" 2-ply sleeve designs are classified as a Level 3 Barrier.
The provided text describes the ComPel MLR™ Surgical Gowns, but it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it details the safety and effectiveness summary for a physical medical device (surgical gowns) and its regulatory clearance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to a diagnostic algorithm.
- Sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details for a diagnostic algorithm.
The document discusses performance criteria for the surgical gowns themselves, such as barrier performance after 75 wash/dry/sterilization cycles, and lists various physical and material tests. These are not applicable to the AI/ML-focused questions you've asked.
§ 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.