(220 days)
The single-use medical 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, provided sterile and non-sterile.
The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are held in place over the users' mouth and nose by ear loops/ ties welded to the mask. The nose clip is made of polypropylene and iron. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-19, which are provided in following table. The difference of the level 1, level 2 and level 3 masks is the gram weight of the melt-blown nonwoven. The gram weight of the melt-blown nonwoven for level 1 is 30g/m², and that for level 2 and level 3 masks is 40g/m². Level 2 and level 3 masks are exactly the same and are divided into level 2 and level 3 just for marking. The proposed devices are provided in sterile and non-sterile two types.
This document describes the premarket notification (510(k)) for a Single-use Medical Face Mask, not an AI/ML medical device. Therefore, the information requested in points 2-9 of your prompt (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document, as it pertains to the performance evaluation of the physical medical face mask against established industry standards.
However, I can extract information related to the acceptance criteria and the study proving the device meets these criteria as presented in the document for the physical medical face mask.
Here's the table of acceptance criteria and reported device performance based on the provided text, focusing on the non-clinical tests:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance (Test Result) |
|---|---|---|
| **Resistance to Penetration | ||
| by Synthetic blood** (ASTM F1862/F1862M-17) | Level 1: No penetration at 80 mmHg; | |
| Level 2: No penetration at 120 mmHg; | ||
| Level 3: No penetration at 160 mmHg | Sterile Tie-on: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHg | |
| Sterile Ear loop: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHg | ||
| Non-sterile Tie-on: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHg | ||
| Non-sterile Ear loop: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHg | ||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-2019) | Level 1: ≥95% | |
| Level 2: ≥98% | ||
| Level 3: ≥98% | Sterile Tie-on: Level 1: 98.48%; Level 2: 99.84%; Level 3: 99.85% | |
| Sterile Ear loop: Level 1: 98.38%; Level 2: 99.86%; Level 3: 99.89% | ||
| Non-sterile Tie-on: Level 1: 98.39%; Level 2: 99.82%; Level 3: 99.87% | ||
| Non-sterile Ear loop: Level 1: 98.67%; Level 2: 99.86%; Level 3: 99.88% | ||
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03 (2017)) | Level 1: ≥95% | |
| Level 2: ≥98% | ||
| Level 3: ≥98% | Sterile Tie-on: Level 1: 99.22%; Level 2: 99.85%; Level 3: 99.88% | |
| Sterile Ear loop: Level 1: 99.23%; Level 2: 99.86%; Level 3: 99.88% | ||
| Non-sterile Tie-on: Level 1: 99.23%; Level 2: 99.87%; Level 3: 99.88% | ||
| Non-sterile Ear loop: Level 1: 99.23%; Level 2: 99.87%; Level 3: 99.87% | ||
| Differential Pressure (EN 14683:2019) | Level 1: 70% of the blank. | |
| And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract. | The viability was ≥70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. | |
| Under the conditions of the study, the proposed device was non-cytotoxic. | ||
| Irritation (ISO 10993-10: 2010) | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
| Sensitization (ISO 10993-10: 2010) | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
Study Details (Relevant to medical device testing, not AI/ML performance)
1. Sample sized used for the test set and the data provenance:
- Sample Size: The document specifies that tests for Resistance to Penetration by Synthetic Blood, Bacterial Filtration Efficiency, Particulate Filtration Efficiency, and Differential Pressure were conducted "from 3 non-consecutive lots." This indicates that at least one sample from each of three different manufacturing lots was tested for these parameters. The exact number of samples per lot is not specified.
- Data Provenance: The tests were non-clinical tests conducted by the manufacturer, Jiangxi Hongda Medical Equipment Group Co., Ltd., based in China, for submission to the U.S. FDA. The document does not specify a country of origin for the data (e.g., patient data), as these are material performance tests, not clinical performance tests. The data is retrospective in the sense that it was collected prior to this submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable for this type of medical device submission. The "ground truth" for a medical face mask's performance is established by standardized test methods (e.g., ASTM, EN, ISO standards) and material properties, not by expert consensus or interpretations of medical images. The tests measure objective physical and biological properties.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving expert interpretation of data (e.g., medical images) where there can be inter-reader variability. For the physical and material performance tests of a face mask, the results are quantitative and objective, based on standardized testing procedures.
4. 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:
- This information is not applicable. This document is for a physical medical device (face mask), not an AI/ML medical device. Therefore, no MRMC comparative effectiveness studies involving human readers and AI assistance were conducted or are relevant to this submission.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is not an AI/ML algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on objective measurements from standardized non-clinical laboratory tests according to recognized consensus standards (ASTM, EN, ISO). For example, Bacterial Filtration Efficiency has a specific test method that yields a quantitative percentage. There is no subjective interpretation or clinical outcomes data used to establish "ground truth" for these performance characteristics.
7. The sample size for the training set:
- This information is not applicable. Since this is a physical medical device (face mask) and not an AI/ML device, there is no "training set" in the context of machine learning. The device production involves manufacturing processes, and testing is performed on samples from production lots.
8. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 7.
§ 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.