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510(k) Data Aggregation
(198 days)
Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.
The Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ties and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the straps are made of nonwoven fabrics, the middle layer is made of melt blown fabrics.
The model of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The ties/ear loops are not made with natural rubber latex. The nose piece on the layers of face mask is to allow the user to fit the face mask around their nose, which is made of Polypropylene with iron core. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (ASTM F2100-23 Level 3) | Reported Performance |
|---|---|---|
| Performance Testing | ||
| Bacterial filtration efficiency (BFE) (%) | ≥98 | 99.7%-99.9% (Pass) |
| Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | 3.2-3.7 mmH2O/cm² (Pass) |
| Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥85 | 97.16-99.52% (Pass) |
| Resistance to penetration by synthetic blood, Minimum pressure | 29 of 32 test articles passed at 160mmHg | 32 of 32 test articles Pass (at 160mmHg, implied) |
| Flame spread | Class 1 | 32 of 32 test articles Pass (Class 1, implied) |
| Biocompatibility Testing | ||
| Cytotoxicity (ISO 10993-5) | Viability < 70%, it has a cytotoxic potential. (Acceptance if no cytotoxic potential) | Tie on: 91.0%; Ear loops: 70.5% (No potential toxicity) |
| Irritation (ISO 10993-23) | Primary Irritation-Index ≤ 2.0 (Response category Negligible) | Primary irritation indexes of both polar and non-polar test groups were 0. (No skin irritation) |
| Sensitization (ISO 10993-10) | Provided grades less than 1, otherwise sensitization. (Acceptance if no sensitization) | Skin sensitization rates of both polar and non-polar extract groups were 0%. (No sensitization) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual performance test (BFE, differential pressure, PFE). However, for Resistance to penetration by synthetic blood and Flame spread, it states that 32 test articles were used.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. Given this is a 510(k) submission for a Chinese manufacturer (Xiantao Daoqi Plastic Co., Ltd.) and tests are cited against international (ISO) and US (ASTM) standards, the testing was likely conducted in laboratories, possibly in China or other accredited facilities. The nature of these tests (bench testing) implies they are prospective assessments of product samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of submission. The ground truth for these medical device tests (surgical face mask performance and biocompatibility) is established by adherence to recognized international and national standards (ASTM, ISO). These standards define specific methodologies and acceptance criteria. No human experts are involved in establishing "ground truth" in the way they would for a diagnostic AI study. The "experts" are the technicians performing the standardized tests and interpreting the results against the defined criteria.
4. Adjudication method for the test set
This information is not applicable. The tests are objective measurements against predefined criteria in recognized standards. There is no adjudication process involving multiple human observers or adjudicators for these types of physical and chemical tests.
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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-powered clinical decision support systems, not for a physical device like a surgical face mask.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The device is a physical surgical face mask.
7. The type of ground truth used
The "ground truth" for this device is established by objective measurements and assessments against recognized performance and biocompatibility standards (ASTM F2100-23, ASTM F2101-23, ASTM F1862/F1862M-17, ISO 10993-5, ISO 10993-23, ISO 10993-10). These standards define the acceptable range of physical properties and biological responses for surgical masks.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI or machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set.
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