(166 days)
The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.
The provided document is a 510(k) premarket notification for a Medical Surgical Mask. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.
However, the request asks for information regarding an AI/Software as a Medical Device (SaMD) study, specifically about acceptance criteria, ground truth establishment, sample sizes for training and testing, expert qualifications, and potential MRMC studies.
The provided document is NOT for an AI/SaMD device. It is for a physical medical device (a surgical mask) and therefore does not contain any of the information requested about AI/SaMD acceptance criteria or study methodologies.
Therefore, I cannot fulfill the request using the provided text. The document discusses:
- Acceptance Criteria (for a physical surgical mask): These are performance standards like Bacterial Filtration Efficiency (BFE), Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, and Flame Spread, as well as Biocompatibility.
- Device Performance: The document states "Passed" for all the listed performance tests against the specified acceptance criteria for Level 2 and Level 3 masks.
- Study That Proves the Device Meets Acceptance Criteria: This is the "Non-Clinical Test Conclusion" section (pages 4-5), where various physical and biological tests were performed according to recognized standards (e.g., ASTM F2101, EN14683, ASTM F1862, 16CFR Part 1610, ISO 10993).
To explicitly address the numbered points in the prompt based on the provided document (even though it's not an AI/SaMD):
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A table of acceptance criteria and the reported device performance:
Performance Testing Purpose Acceptance Criteria for Level 2 Barrier Acceptance Criteria for Level 3 Barrier Result Bacterial Filtration Efficiency ASTM F2101 Measure bacterial filtration efficiency ≥98% ≥98% Passed Differential Pressure (mm H2O/cm2) Determine breathability of a mask
§ 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.