(267 days)
Disposable Surgical Gowns, which are blue colored and EO sterilized, are indicated 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. It could achieve Level 3 Barrier Performance as per AAMI PB70:2003. It is for single use only.
Disposable 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. Disposable Surgical Gowns are manufactured from three layers nonwoven fabric that is comprised of Spunbond (SMS) materials. Disposable Surgical Gowns are reinforced with an additional layer of SPP (Syndiotactic Polyprogylene) laminating film in the sleeve and body areas for higher barrier protection. The proposed Disposable Surgical Gowns include four sizes, which are presented in Table V-1 General Description.
The provided text describes a 510(k) summary for disposable surgical gowns, focusing on their physical and biological properties. It does not contain any information about an AI-powered device, a test set, expert readers, or ground truth establishment in the context of medical imaging or diagnostic algorithms.
Therefore, I cannot fulfill your request to describe acceptance criteria and study proving device meets acceptance criteria for an AI device based on the provided text.
The document discusses:
- Device: Disposable Surgical Gowns
- Intended Use: Protection during surgical procedures.
- Acceptance Criteria (for this product): Primarily physical barrier performance (e.g., Level 3 per AAMI PB70), tear strength, fire protection, and biocompatibility, along with manufacturing standards. These are verified through bench tests against established standards (e.g., ASTM, AAMI, ISO).
- Study Proving Acceptance: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards..."
The text provided does not contain the information requested for an AI-powered device, such as:
- A table of acceptance criteria and reported device performance (for an AI).
- Sample size for a test set or data provenance for an AI.
- Number of experts or their qualifications for ground truth establishment for an AI.
- Adjudication method for a test set for an AI.
- MRMC comparative effectiveness study or effect size for AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth (expert consensus, pathology, outcomes data) for an AI.
- Sample size for a training set for an AI.
- How ground truth for the training set was established for an AI.
The information is related to the regulatory approval process for a physical medical device (surgical gowns), not an AI/software as a medical device.
§ 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.