(239 days)
The Sklar Surgical Gown is a single use, sterile or non-sterile item that is intended to be used in the operating room to be a protective covering, for operating room staff, from the transfer of body fluids and particulates.
The Sklar Surgical Gown is a disposable item that is intended to be used in the operating room as a protective covering, for operating room staff, from the transfer of body fluids and particulates.
The Sklar Surgical Gown is provided as sterile and non-sterile.
Sterile gowns are to be sold directly to users following EtO sterilization validation according to ISO 11135-1:2007. Non-sterile gowns are to be sold to OEMs for EtO sterilization according to ISO 11135-1:2007.
The Sklar Surgical Gown is an open back gown manufactured from a non-woven fabric. The non-woven fabric is a polypropylene spunbond meltblown and the fibers are mechanically bonded together. The Surgical Gown comes in various sizes without any areas of reinforcement. The Surgical Gowns are supplied sterile and non-sterile, for single use only.
The provided text describes a 510(k) premarket notification for the "Sklar Surgical Gown." This document focuses on the regulatory submission and approval process for a medical device (a surgical gown), rather than a study evaluating the performance of an AI/ML powered device.
Therefore, the information required to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not present in the provided text.
The text includes:
- Device Name: Sklar Surgical Gown
- Classification: Class II, 21 CFR 878.4040, Product Code: FYA (Surgical Apparel)
- Predicate Device: Welmed Inc. Surgical Gowns - K070431
- Device Description: Open back gown from non-woven fabric (polypropylene spunbond meltblown), various sizes, no reinforcement, supplied sterile and non-sterile for single use.
- Indications for Use: "A single use, sterile or non-sterile item that is intended to be used in the operating room to be a protective covering, for operating room staff, from the transfer of body fluids and particulates."
- Regulatory Outcome: Found substantially equivalent to a predicate device.
To answer your request, I would need a document detailing a study specifically designed to evaluate an AI/ML device against acceptance criteria, including performance metrics, data sets, expert review, and statistical analyses.
§ 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.