(178 days)
The Disposable Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face 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, provided non-sterile.
The proposed device, Disposable Face Mask is a three-layer, single-use, flat-pleated mask. The ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. The disposable surgical mask is available in four different specifications: 14.5cmx9.5cm and 17.5cmx9.5cm. The device is single use and provided non-sterile.
The provided text describes the 510(k) submission for a Disposable Face Mask (K202905) and its equivalence to a predicate device (K160269). However, it does not contain information related to an AI/ML-enabled medical device or a clinical study involving human readers and AI assistance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI device. The document is strictly about the non-clinical testing and comparison of a traditional medical device (face mask) to a predicate device to demonstrate substantial equivalence.
The document covers:
- Device: Disposable Face Mask
- Purpose: To protect against transfer of microorganisms, body fluids, and particulate material.
- Regulatory Class: Class II, Product Code FXX.
- Acceptance Criteria/Performance (based on standards for face masks):
- Fluid Resistance (ASTM F1862)
- Particulate Filtration Efficiency (ASTM F2299)
- Bacterial Filtration Efficiency (ASTM F2101)
- Differential Pressure (EN 14683)
- Flammability (16 CFR 1610)
- Biocompatibility (ISO 10993-5 and ISO 10993-10)
Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI/ML specifics:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device K202905) | Remark |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Level 1 Pass at 80mmHg; Level 2 Pass at 120mmHg | Level 1 Pass at 80mmHg; Level 2 Pass at 120mmHg | Identical |
| Particulate Efficiency (ASTM F2299) | Pass at 99.6% (implied for Level 1 & 2 for predicate) | $\ge 95%$ (Level 1), $\ge 98%$ (Level 2) | Similar (Meets Level 2 requirements) |
| Bacterial Filtration Efficiency (ASTM F2101) | Pass at >98% (implied for Level 1 & 2 for predicate) | $\ge 95%$ (Level 1), $\ge 98%$ (Level 2) | Similar (Meets Level 2 requirements) |
| Differential Pressure (EN 14683) | Passed at 2.0 mmH2O/cm² (predicate's Level 1), Passed at 1.6 mmH2O/cm² (predicate's Level 2) | $ |
§ 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.