(18 days)
The Convertors®Breathable Surgical Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The gowns are comprised of a composite fabric of nonwoven fabric, monolithic breathable impervious film and nonwoven fabric.
The provided text is a 510(k) Summary of Safety and Effectiveness for "Convertors Breathable Surgical Gowns." It describes the device, its intended use, and substantial equivalence to a predicate device, focusing on material biocompatibility and performance attributes. However, it does not include information about clinical studies with human subjects, AI algorithms, or specific detailed performance metrics commonly associated with AI/ML medical devices.
Therefore, I cannot provide the requested information in the format given because the document does not contain:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes. The "performance attributes are similar" statement is too general.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods. The testing mentioned is for material biocompatibility ("cytotoxicity, sensitization, and irritation/intracutaneous reactivity") and "industry recognized test methods" for materials, not clinical performance in a diagnostic context.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance. This device is a surgical gown, not a diagnostic imaging device or AI software.
- Sample size or ground truth establishment for a training set. There is no AI model being trained discussed.
Summary of available information related to acceptance criteria and "study":
The document states that:
- Intended Use: "Surgical apparel are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material."
- Substantial Equivalence: The gowns are substantially equivalent to the Convertors® Breathable gowns because "the intended use is the same" and "the performance attributes are similar."
- Summary of Testing: "All materials used in the fabrication of this Convertors®Breathable Gowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices"."
- Specific Biocompatibility Tests: "cytotoxicity, sensitization, and irritation/intracutaneous reactivity."
- Additional Material Testing: "These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use."
This information focuses on material safety and equivalence to a predicate device, which are the relevant "acceptance criteria" and "studies" for this type of medical device (a surgical gown) as described in 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.