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510(k) Data Aggregation
(218 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for Adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.
UNIWEB SURGICAL MASK are 3-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit.
The provided text describes the acceptance criteria and the study results for the UNIWEB Surgical Mask, a medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose of the Test | Acceptance Criteria (Level 1) | Reported Performance (UNIWEB Surgical Mask - Level 1) | Acceptance Criteria (Level 2) | Reported Performance (UNIWEB Surgical Mask - Level 2) |
|---|---|---|---|---|---|
| Bacteria Filtration Efficiency | Determine bacterial filtration efficiency as directed in ASTM F2101 | ≥ 95 % | 96/96 (3 lots) passed at ≥ 99% | ≥ 98 % | 96/96 (3 lots) passed at ≥ 99% |
| Particle Filtration Efficiency | Determine particulate filtration efficiency as directed in ASTM F2299 | ≥ 95 % | 96/96 (3 lots) passed at ≥ 99% | ≥ 98 % | 96/96 (3 lots) passed at ≥ 99% |
| Differential Pressure (Delta-P) | Determine breathing resistance/differential pressure as directed in EN 14683:2019, Annex C | < 5.0 mmH₂O/cm² | 96/96 (3 lots) show 3.6-4.2 H₂O/cm², pass at < 5.0 H₂O/cm² | < 6.0 mmH₂O/cm² | 96/96 (3 lots) show 3.6-4.2 H₂O/cm², pass at < 6.0 H₂O/cm² |
| Resistance to Penetration by Synthetic Blood | Determine synthetic blood penetration resistance as specified in Test Method F1862 | 80 mmHg (≥ 29/32 show passing results per lot) | 96/96 (3 lots) passed at 80 mmHg | 120 mmHg (≥ 29/32 show passing results per lot) | 95/96 (3 lots) passed at 120 mmHg |
| Flammability | Determine flammability as specified in 16 CFR Part 1610 | Class I (Burn time ≥ 3.5 s, IBE, or DNI) | 96/96 (3 lots) show IBE, passed at class I | Class I (Burn time ≥ 3.5 s, IBE, or DNI) | 96/96 (3 lots) show IBE, passed at class I |
Biocompatibility Testing:
| Test Methodology | Purpose of the Test | Acceptance Criteria | Test Results |
|---|---|---|---|
| In vitro Cytotoxicity test | Determine the effects on cells following ISO 10993-5 | Cell viability of 100% test article extract is ≥ 70% of control group | Passed |
| Skin sensitization Test | Estimate the potential for contact sensitization following ISO 10993-10 | Grades = 0 | Passed |
| Skin Irritation Test | Estimate the irritation potential of medical device following ISO 10993-10 | Mean score 0-0.4 (Negligible) | Passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: The non-clinical tests used "3 lots" of the UNIWEB Surgical Mask for evaluation. For each test, results are reported as "96/96 (3 lots)" or "95/96 (3 lots)" indicating the number of successful samples out of a total of 96 samples across the 3 lots.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the manufacturer is listed as "UNIVERSAL INCORPORATION, Zhongshan Dist., Taipei City, 10446, Taiwan," which suggests the testing was likely conducted in or overseen by entities associated with Taiwan. The nature of the tests (non-clinical, standard laboratory tests for medical devices) means the data provenance is less about patient demographics and more about adherence to international testing standards (ASTM, EN, ISO, CFR). The data is retrospective in the sense that the tests were completed and the results compiled for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes non-clinical performance and biocompatibility testing for a surgical mask. No human experts were used to establish ground truth in the way they would for diagnostic imaging or clinical trials. The "ground truth" for these tests is defined by the objective performance standards and methodologies outlined in the referenced international standards (e.g., ASTM F2101 for Bacterial Filtration Efficiency, ISO 10993 for Biocompatibility). The tests themselves provide the objective data.
4. Adjudication method for the test set:
- Given that these are non-clinical, objective laboratory tests against pre-defined international standards, there was no adjudication method as typically applied in studies involving human interpretation or clinical outcomes (e.g., 2+1, 3+1). The results are quantitative and directly compared against the numerical acceptance criteria.
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 MRMC comparative effectiveness study was done. This submission is for a physical medical device (surgical mask) and not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- As this is a physical medical device (surgical mask), no standalone algorithm performance study was conducted.
7. The type of ground truth used:
- The "ground truth" for the performance tests consists of objective, quantitatively measurable properties of the mask as defined by recognized international standards and test methodologies (e.g., ASTM F2101, ASTM F2299, EN 14683, ASTM F1862, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards themselves serve as the basis for determining whether the device "meets" its intended performance.
8. The sample size for the training set:
- This is a submission for a physical medical device. There is no "training set" in the context of machine learning or AI. The product undergoes manufacturing and quality control, and then specific production lots are sampled for performance validation testing.
9. How the ground truth for the training set was established:
- As there is no "training set" in the AI sense for this device, this question is not applicable. The design and manufacturing process would be guided by the requirements of the standards, and then validated by the non-clinical tests described.
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