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510(k) Data Aggregation
(113 days)
The Procedure mask/Surgical 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, provided 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 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 used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.
The provided text is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). It details non-clinical tests conducted to prove substantial equivalence to a predicate device, rather than the development and validation of an AI-powered diagnostic device.
Therefore, I cannot extract information related to:
- Study that proves the device meets acceptance criteria: The document describes non-clinical performance testing of a physical product (face mask) against established standards, not an AI model's performance.
- Sample size used for the test set and data provenance: No test set of patient data, images, or cases is mentioned. The tests are on material properties of the mask.
- Number of experts used to establish ground truth and qualifications: Ground truth for a face mask's performance is established by standardized physical and biological tests, not expert consensus on medical images or patient data.
- Adjudication method for the test set: Not applicable as there's no diagnostic test set requiring adjudication.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating human reader performance with and without AI assistance for interpretation tasks.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to the measured physical and biological properties of the mask.
- Sample size for the training set: There is no training set mentioned, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Instead, I can present the acceptance criteria and reported device performance from the non-clinical tests for the traditional medical device (face mask) as provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Result (Proposed Device) |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M: 2017) | To evaluate the effectiveness of the test article from possible exposure to blood and other body fluids. | Level 1: No penetration at 80 mmHg | Level 1: Pass at 80mmHg |
| Level 2: No penetration at 120 mmHg | Level 2: Pass at 120mmHg | ||
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03 (2017)) | To determine the particle filtration efficiency (PFE) of the test article. | Level 1: ≥95% | Blue mask: Pass at 96.05% Black mask: Pass at 96.03% |
| Level 2: ≥98% | Blue mask: Pass at 98.78% Black mask: Pass at 98.75% | ||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101: 2019) | To determine the bacterial filtration efficiency (BFE) of the test article. | Level 1: ≥95% | Blue mask: Pass at 98.25% Black mask: Pass at 98.25% |
| Level 2: ≥98% | Blue mask: Pass at 98.72% Black mask: Pass at 98.73% | ||
| Differential Pressure (EN 14683:2019+AC: 2019 Annex C) | To determine the differential pressure of the test article. | Level 1: <5.0 mmH2O/cm² | Blue mask: Pass at 3.5 mmH2O/cm² Black mask: Pass at 3.5 mmH2O/cm² |
| Level 2: <6.0 mmH2O/cm² | Blue mask: Pass at 3.5 mmH2O/cm² Black mask: Pass at 3.6 mmH2O/cm² | ||
| Flammability (16 CFR Part 1610) | To evaluate the flammability of the test article. | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5:2009) | To evaluate the cytotoxicity of the test article. | The viability should be ≥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. |
| Sensitization (ISO 10993-10:2010) | To evaluate the sensitization of the test article. | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation (ISO 10993-10:2010) | To evaluate the irritation of the test article. | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
2. Sample size used for the test set and the data provenance
The document does not specify general "sample sizes" in terms of number of patient cases or images, as this is a physical product's performance validation. The "tests" refer to laboratory evaluations of material properties. The provenance of the testing data is not explicitly stated beyond being "non-clinical tests" conducted to verify compliance with standards. It does not indicate country of origin for test data or whether tests were retrospective or prospective, as these are material property tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device (a face mask) is established by adherence to recognized international and national standards (e.g., ASTM, EN, ISO, CFR) for material performance, not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no diagnostic test set requiring human adjudication.
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
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for physical medical devices like face masks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the results of standardized physical and biological tests, which measure specific material properties and performance characteristics against predefined thresholds in the cited standards (e.g., ASTM F1862/F1862M for synthetic blood penetration, ASTM F2101 for bacterial filtration efficiency, ISO 10993 for biocompatibility).
8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI model.
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