(86 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 Masks are single use, three-layer, flat –folded masks with ear loops/tie coverall and nose clamp. The Surgical Face Masks are 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 Nylon and spandex and the ties are made of polypropylene nonwoven. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PP coated steel wire. The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold non- sterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and the study that proves the device meets those criteria for a Surgical Face Mask (K212368) manufactured by Anhui Tiankang Medical Technology Co., Ltd.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Synthetic Blood Penetration ASTM F1862 | Demonstrate resistance to liquid penetration | ≥ 29 samples out of 32 pass (AQL 4%) |
- Level 1: pass at 80mmHg
- Level 2: pass at 120mmHg
- Level 3: pass at 160mmHg | Pass |
| Particulate Filtration Efficiency ASTM F2299 | Demonstrate particulate filtration | 29 out of 32 pass - Level 1: pass at ≥95%
- Level 2: pass at ≥98%
- Level 3: pass at ≥98% | Pass |
| Bacterial Filtration Efficiency ASTM F2101 | Demonstrate bacterial filtration | 29 out of 32 pass - Level 1: pass at ≥95%
- Level 2: pass at ≥98%
- Level 3: pass at ≥98% | Pass |
| Differential Pressure (Delta P) EN 14683 Annex C | Demonstrate breathability | 29 out of 32 pass - Level 1: pass at ≤ 5.0 mmH₂0/cm²
- Level 2: pass at ≤ 6.0 mmH₂0/cm²
- Level 3: pass at ≤ 6.0 mmH₂0/cm² | Pass |
| Flammability 16 CFR 1610 | Demonstrate flame resistance | Class I | Pass |
| Cytotoxicity ISO 10993-5 | Demonstrate cytotoxic biocompatibility | Under the conditions of the study, the device is non-cytotoxic. | Pass |
| Skin Irritation ISO 10993-10 | Demonstrate non-irritability | Under the conditions of the study, the device is non-irritating. | Pass |
| Skin Sensitization ISO 10993-10 | Demonstrate non-sensitization | Under the conditions of the study, the device is non-sensitizing. | Pass |
2. Sample size used for the test set and the data provenance
The sample sizes for the functional performance tests (Synthetic Blood Penetration, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure) were 32 samples for each test. For these tests, the acceptance criteria are generally "≥ 29 samples out of 32 pass".
The document does not explicitly state the country of origin for the studies, nor if they were retrospective or prospective. However, given that these are non-clinical performance tests for a device submitted to the FDA by a company in China, it is highly likely that the tests were conducted in a laboratory setting, potentially in China or a certified testing facility elsewhere. They are by nature prospective tests, performed specifically to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the described studies are non-clinical performance tests of a physical product (surgical face mask), not diagnostic or interpretative studies requiring human expert ground truth.
4. Adjudication method for the test set
This information is not applicable for these types of mechanical and biological compatibility tests. The results are typically objectively measured by instruments or laboratory methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC study conducted. This document describes the performance testing of a physical medical device (surgical face mask), not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical surgical face mask, not an algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on objective measurements and chemical/biological assays as defined by recognized international and national standards (ASTM, EN, ISO, CFR). For example:
- Synthetic Blood Penetration: Measured resistance to fluid penetration at specific pressures.
- Particulate/Bacterial Filtration Efficiency: Measured percentage of particles/bacteria filtered.
- Differential Pressure: Measured breathability in mmH₂0/cm².
- Flammability: Determined by specific flame resistance classifications.
- Biocompatibility (Cytotoxicity, Skin Irritation, Sensitization): Determined by laboratory assays evaluating cellular responses or skin reactions under specified conditions.
8. The sample size for the training set
This information is not applicable as the described device is a physical product and not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the described device is a physical product and not an AI/machine learning model.
§ 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.