(83 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 a single use, disposable device(s), provided non-sterile.
The Surgical Face Masks are blue, flat pleated masks with ear loops to hold the device in place over the user's mouth and nose and a nose piece to fit the mask to the face. The proposed device(s) 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 ear loops are polyester. They are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of face mask and is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text is a 510(k) Summary for a Surgical Face Mask. This type of document is for demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical specifications, rather than clinical studies proving a specific performance metric against a disease outcome or a human-AI comparative effectiveness study for an AI-based medical device.
Therefore, many of the requested points related to AI/MRMC studies, ground truth establishment, expert consensus, and human reader performance are not applicable to this submission. This document focuses on the physical and performance characteristics of a surgical face mask.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device (surgical face mask) are based on established international and national standards for material performance and safety, primarily
ASTM F2100 for medical face mask performance, and ISO 10993 for biocompatibility.
Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Testing (ISO 10993) | |||
| Cytotoxicity | To demonstrate the biocompatibility of the subject device. | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. |
| Irritation | To demonstrate the biocompatibility of the subject device. | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. |
| Sensitization | To demonstrate the biocompatibility of the subject device. | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. |
| Performance Testing (ASTM F2100, etc.) | |||
| Fluid Resistance ASTM F1862 | To demonstrate the functionality of the subject device. | For Level 2: 29 out of 32 pass at 120 mmHg. For Level 3: 29 out of 32 pass at 160 mmHg. | PASS: 32 out of 32 per lot pass at 120 mmHg (3 non-consecutive lots tested).32 out of 32 per lot pass at 160 mmHg (2 non-consecutive lots tested).30 out of 32 per lot pass at 160 mmHg (1 lot tested).(This indicates the device meets both Level 2 and Level 3 fluid resistance requirements, although it's categorized as Level 2 & 3 in the summary and compared to a Level 2 predicate). |
| Particulate Filtration Efficiency ASTM F2299 | To demonstrate the functionality of the subject device. | ≥ 98% | PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.79%Lot2: 99.58%Lot3: 99.6% |
| Bacterial Filtration Efficiency ASTM F2101 | To demonstrate the functionality of the subject device. | ≥ 98% | PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.56%Lot2: 99.9%Lot3: 99.84% |
| Differential Pressure (Delta P) EN 14683 Annex C | To demonstrate the functionality of the subject device. | Lot1: 5.2 mmH2O/cm²Lot2: 3.8 mmH2O/cm²Lot3: 3.8 mmH2O/cm² | |
| Flammability 16 CFR 1610 | To demonstrate the functionality of the subject device. | Class 1 | PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Class 1. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), specific sample sizes are not explicitly stated as numerical values (e.g., number of masks or subjects), but the results indicate that the tests were performed sufficiently to declare "PASS" for the acceptance criteria.
- For performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), the sample size for each lot tested was 32 units.
- Data Provenance: The tests were non-clinical, laboratory-based tests performed by the manufacturer, Macheng Thimble Technology Investment Co., Ltd, based in Hubei Province, China. The document does not specify whether the data is retrospective or prospective, as these terms typically apply to clinical studies using patient data. These are results from product testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. The "ground truth" for this type of device is established by the specified performance standards (e.g., ASTM, ISO, EN). There is no "truth" established by human experts in the context of interpreting medical images or making diagnoses. The tests performed are objective, quantitative measurements.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for studies involving human interpretation and consensus (e.g., in clinical trials or image reading studies). This submission relies on objective laboratory test results.
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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:
- Not applicable. This is a physical product (surgical face mask), not an AI-based diagnostic or imaging device. Therefore, MRMC studies are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or standard for compliance is defined by the acceptance criteria specified in recognized industry standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683 Annex C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These are objective, measurable parameters.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured product tested against established standards.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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.