(140 days)
The Surgical Face Masks are 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 and nose piece. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Galvanized iron wire. 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 document describes the acceptance criteria and performance of a Surgical Face Mask (K222483), not an AI-powered diagnostic device. Therefore, the questions related to AI/algorithm performance (such as MRMC studies, standalone performance, training set details, ground truth for training data, expert qualifications, and adjudication methods for specific diagnoses) are not applicable to this submission.
However, I can extract and present the acceptance criteria and study results for this medical device based on the non-clinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Synthetic Blood Penetration (ASTM F1862) | Demonstrate resistance to liquid penetration | Level 1: 29 samples out of 32 pass (AQL 4%) at 80mmHg | Pass: 32 out of 32 pass at 80 mmHg (3 lots) |
| Level 2: 29 samples out of 32 pass (AQL 4%) at 120mmHg | Pass: 32 out of 32 pass at 120 mmHg (3 lots) | ||
| Level 3: 29 samples out of 32 pass (AQL 4%) at 160mmHg | Pass: 32 out of 32 pass at 160 mmHg (3 lots) | ||
| Particulate Filtration Efficiency (ASTM F2299) | Demonstrate particulate filtration | Level 1: ≥95% | Pass: Average 98.24% |
| Level 2: ≥98% | Pass: Average 98.75% | ||
| Level 3: ≥98% | Pass: Average 99.67% | ||
| Bacterial Filtration Efficiency (ASTM F2101) | Demonstrate bacterial filtration | Level 1: ≥95% | Pass: Average 99.18% |
| Level 2: ≥98% | Pass: Average 99.20% | ||
| Level 3: ≥98% | Pass: Average 99.21% | ||
| Differential Pressure (Delta P) (EN 14683 Annex C) | Demonstrate breathability | Level 1: ≤ 5.0 mmH2O/cm² (ASTM F2100 implies this for Level 1, though not explicitly stated in table against EN 14683) | Pass: Average 3.75 mmH2O/cm² |
| Level 2: ≤ 6.0 mmH2O/cm² | Pass: Average 4.25 mmH2O/cm² | ||
| Flammability (16 CFR 1610) | Demonstrate flame resistance | Class I Pass | Pass: Class I |
| Cytotoxicity (ISO 10993-5) | Demonstrate cytotoxic biocompatibility | Under the conditions of the study, the device is non-cytotoxic. | Pass: Under the conditions of the study, the device is non-cytotoxic. |
| Skin Irritation (ISO 10993-10) | Demonstrate non-irritability | Under the conditions of the study, the device is non-irritating. | Pass: Under the conditions of the study, the device is non-irritating. |
| Skin Sensitization (ISO 10993-10) | Demonstrate non-sensitization | Under the conditions of the study, the device is 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 out of 32 pass" and "3 lots" are mentioned. This suggests at least 32 samples per lot were tested, across 3 lots.
- Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure): The sample size for these specific tests is not explicitly stated, but averages are provided, indicating multiple samples were tested for each.
- Biocompatibility (Cytotoxicity, Skin Irritation, Skin Sensitization): The sample size is not explicitly stated.
- Data Provenance: Not specified, but generally, such tests are conducted by certified testing laboratories commissioned by the manufacturer, Hubei Woozon Healthcare Co.,Ltd., located in China. These are non-clinical in vitro/in vivo tests on the device materials, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document pertains to the performance testing of a physical medical device (surgical face mask) against established industry standards. There is no diagnostic algorithm or ground truth to be established by experts in the context of this submission. The "ground truth" here is adherence to specified technical standards (e.g., minimum filtration efficiency, maximum differential pressure).
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. Test results are determined by objective measurements per standard protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
This is not applicable. This submission concerns a physical medical device, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm for this device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance is defined by established international and national standards (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, ISO 10993 series, EN 14683 Annex C, 16 CFR 1610). The device is tested against these predefined criteria, and its performance is measured directly against those benchmark values.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a physical medical device undergoing performance testing.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
§ 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.