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510(k) Data Aggregation
(82 days)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. They are 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 proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex and polyester fiber. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) summary for a Medical Face Mask, indicating it's a submission for clearance rather than a detailed study report. Therefore, information related to AI or clinical studies (such as MRMC, direct human-in-the-loop improvements, independent algorithm performance, expert ground truth establishment for AI, or training set details) will not be present.
The acceptance criteria and device performance are based on non-clinical tests required for establishing substantial equivalence for medical face masks.
Here's a summary of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Surgical Face Mask (HuBei Kangning Protective Products Co., Ltd.)
Predicate Device: Surgical Face Mask (Non-sterile) (K203426) by Nantong Taiweishi Medical Technology Co., Ltd.
ASTM F2100 Level: Level 2
| Test Methodology | Acceptance Criteria (Level 2) | Reported Device Performance (mean or range from 3 lots) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 120 mmHg | Lot1: 31 out of 32 Pass at 120 mmHgLot2: 29 out of 32 Pass at 120 mmHgLot3: 31 out of 32 Pass at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 99.79%Lot2: 99.83%Lot3: 99.82% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.9%Lot2: 99.9%Lot3: 99.9% |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH2O/cm² | Lot1: 4.4 mmH2O/cm²Lot2: 4.3 mmH2O/cm²Lot3: 4.3 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Lot1: Class ILot2: Class ILot3: Class I |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation (ISO 10993-10) | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates testing was performed on three different lots of the device. For specific tests like Fluid Resistance, the sample size per lot was 32 units. For other tests, such as filtration efficiencies, differential pressure, and flammability, while not explicitly stated per test, the results are reported for each of the three lots, implying samples were drawn from each lot as per the respective standard's requirements.
The data provenance is from HuBei Kangning Protective Products Co., Ltd., China, as per the applicant information. These are non-clinical (laboratory) tests, not patient-derived data, and thus are inherently "retrospective" in the sense that they were conducted on already manufactured product lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes non-clinical performance and biocompatibility testing for a physical device (surgical face mask), not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for these tests is defined by the objective measurement procedures detailed in the referenced ASTM, EN, and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. This pertains to expert review of data, which is not relevant for the objective laboratory tests conducted for a medical face mask.
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
Not applicable. This document is for the clearance of a physical medical device (surgical face mask) and does not involve AI software or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for the clearance of a physical medical device (surgical face mask) and does not involve AI software or algorithms.
7. The Type of Ground Truth Used
The "ground truth" for the performance and biocompatibility tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards specify the methodology and acceptable limits for each characteristic.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The tests are laboratory validations of a physical product against established safety and performance standards.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set or AI component, this information is not relevant to the content of the provided document.
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