(84 days)
The Surgical 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(s), provided non-sterile.
The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops/tie-coverall and nose piece. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of polyester and spandex, the ties are made of spun-bond polypropylene. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and aluminum. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.
The provided text describes the regulatory clearance for a Surgical Face Mask (K222529). This is a medical device, not an AI/ML-driven device, therefore, many of the typical acceptance criteria and study designs associated with AI/ML systems (such as expert consensus, MRMC studies, training set details, or an 'algorithm only' performance) are not applicable.
The acceptance criteria here pertain to the physical and performance characteristics of the surgical face mask, comparing it to established industry standards (ASTM, ISO, EN, CFR) for medical face masks. The study proving the device meets these criteria is a non-clinical performance and biocompatibility testing.
Here's the information extracted from the provided text, adapted to the requested format where applicable, and noting when a requested AI/ML specific criterion is not relevant to this type of device:
Device Name: Surgical Face Mask (Xiantao Rayxin Medical Products Co., Ltd.)
Regulatory Classification: Class II Surgical Apparel (Product Code FXX, 21 CFR 878.4040)
Predicate Device: Surgical Face Mask (K212368, Anhui Tiankang Medical Technology Co., Ltd.)
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criterion | Purpose | Acceptance Criteria | Reported Results |
|---|---|---|---|
| Synthetic Blood Penetration (ASTM F1862) | Demonstrate resistance to liquid penetration | Level 1: 29 samples out of 32 pass (AQL 4%) at 80mmHg | |
| Level 3: 29 samples out of 32 pass (AQL 4%) at 160mmHg | Level 1: Pass - 32 out of 32 pass at 80mmHg (3 lots) | ||
| Level 3: Pass - 32 out of 32 pass at 160mmHg (3 lots) | |||
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Demonstrate particulate filtration | Level 1: ≥95% | |
| Level 3: ≥98% | Level 1: Pass - Average 98.50% | ||
| Level 3: Pass - Average 98.83% | |||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Demonstrate bacterial filtration | Level 1: ≥95% | |
| Level 3: ≥98% | Level 1: Pass - Average 99.27% | ||
| Level 3: Pass - Average 99.79% | |||
| Differential Pressure (Delta P) (Breathability) (EN 14683 Annex C) | Demonstrate breathability | Level 1: ≤ 5.0 mmH2O/cm² | |
| Level 3: ≤ 6.0 mmH2O/cm² | Level 1: Pass - Average 3.11 mmH2O/cm² | ||
| Level 3: Pass - Average 3.97 mmH2O/cm² | |||
| Flammability (16 CFR 1610) | Demonstrate flame resistance | Class I | Pass |
| Cytotoxicity (ISO 10993-5) | Demonstrate cytotoxic biocompatibility | Non-cytotoxic | Pass - Under the conditions of the study, the device is non-cytotoxic. |
| Skin Irritation (ISO 10993-10) | Demonstrate non-irritability | Non-irritating | Pass - Under the conditions of the study, the device is non-irritating. |
| Skin Sensitization (ISO 10993-10) | Demonstrate non-sensitization | Non-sensitizing | Pass - Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Synthetic Blood Penetration: 32 samples per test condition for each of 3 lots.
- Other Performance Tests (PFE, BFE, Delta P, Flammability): Specific sample sizes are not explicitly stated for each of these, but performance is reported as averages or 'Pass' implying multiple samples were tested to demonstrate compliance with the standards.
- Biocompatibility Tests: Sample sizes are not explicitly stated.
- Data Provenance: The tests appear to be laboratory performance tests, not clinical data from patients. The sponsor, Xiantao Rayxin Medical Products Co., Ltd., is based in China. The specific location where these tests were performed is not detailed, but it would typically be a certified testing laboratory. The data is based on prospective testing of the manufactured devices to the specified standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This is a hardware device where ground truth is established through standardized laboratory measurements and physical properties, not human interpretation or expert consensus. The "ground truth" is defined by the performance standards themselves (e.g., a specific percentage filtration, a specific pressure differential).
4. Adjudication Method for the Test Set:
- Not applicable. See point 3. Testing involves objective measurements against established physical and chemical standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an AI/ML-assisted diagnostic device, so an MRMC study is not relevant. The device's effectiveness is based on its physical barrier properties and breathability, not its ability to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is a physical product (surgical face mask), not an algorithm or software. The concept of "standalone performance" for an algorithm is not applicable here.
7. The Type of Ground Truth Used:
- Standardized Physical and Chemical Measurements & Definitions: Ground truth is defined by the requirements of the specific ASTM, ISO, EN, and CFR standards referenced. For example, "Level 1 pass at ≥95%" for BFE means that any value of 95% or higher, as measured by the ASTM F2101 method, constitutes a 'pass'. This is an objective, quantitative ground truth.
8. The Sample Size for the Training Set:
- Not applicable. This is a manufactured product, not an AI/ML model that undergoes a "training" phase.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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.