(135 days)
The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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 proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. It is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of polyester and polyurethane, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is made of polyethylene.
The proposed device is provided non-sterile and is intended to be a single use, disposable device.
The provided text is a 510(k) Summary for a Surgical Face Mask. It outlines the device, its intended use, and comparative data against predicate and reference devices to demonstrate substantial equivalence. However, this document does not describe the specific study design elements typically associated with proving a device meets acceptance criteria for an AI/ML-based medical device, as requested in the prompt.
The document details performance testing for physical characteristics of a surgical face mask (e.g., fluid resistance, filtration efficiency, flammability, biocompatibility), which are relevant for demonstrating the safety and effectiveness of the mask itself. It does not contain information about an AI/ML algorithm or its performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the AI/ML device meets the acceptance criteria based on the provided text. The text is for a physical medical device (surgical face mask), not an AI/ML device.
If the request was simply to describe the acceptance criteria and study proving the surgical face mask meets its criteria, the following information can be extracted:
1. A table of acceptance criteria and the reported device performance:
| Test | Purpose | Acceptance Criteria per ASTM F2100-20 (AQL=4.0%) | Reported Device Performance (Statistics of three lots, 32 per lot) |
|---|---|---|---|
| Biocompatibility Testing | |||
| In vitro Cytotoxicity (ISO 10993-5) | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the research conditions. | Pass |
| Skin Irritation (ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the research conditions. | Pass |
| Skin Sensitization (ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the research conditions. | Pass |
| Performance Testing - Bench | |||
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-20. | Pass at 160 mmHg | 96 out of 96 pass at 160 mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-20. | ≥98% | 99.8%~>99.9% (Average: ≥99.9%) |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-20. | ≥98% | 99.0%~99.8% (Average: 99.6%) |
| Differential Pressure (Delta-P) (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-20. |
§ 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.