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510(k) Data Aggregation
(208 days)
The Disposable Medical 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. The Disposable Medical Surgical Mask 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 sterile.
The Disposable Medical 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. The Disposable Medical Surgical Mask 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 sterile.
The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric.
The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex.
The nose piece contained in the proposed device(s) is contained within the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire.
The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.
The provided document is a 510(k) Summary for a medical device, a "Disposable Medical Surgical Mask". It details the device's technical characteristics, performance, and biocompatibility compared to a predicate device, as well as the non-clinical tests performed to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration by synthetic blood | 120 mm Hg | 120 mm Hg (Table 2 and Test Method/Results table, page 7) |
| ASTM F2299 | Sub-micron particulate filtration efficiency at 0.1 micron | ≥ 98% | ≥ 98% (Table 2 and Test Method/Results table, page 7) |
| ASTM F2101 | Bacterial Filtration Efficiency | ≥ 98% | ≥ 99% (Table 2 and Test Method/Results table, page 7) |
| EN 14683 Annex C | Differential Pressure | < 6.0 mm H2O/cm² | < 5.7 mm H2O/cm² (Table 2 and Test Method/Results table, page 7) |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 (Table 2 and Test Method/Results table, page 7) |
| ISO 10993-10 | Irritation | No irritation effect | Under the conditions of the study, no irritation effect (Table 3 and Test Method/Results table, page 7) |
| ISO 10993-10 | Sensitization | No sensitization effect | Under the conditions of the study, no sensitization effect (Table 3 and Test Method/Results table, page 7) |
| ISO 10993-5 | Cytotoxicity | No cytotoxicity effect | Under the conditions of the study, no cytotoxicity effect (Table 3 and Test Method/Results table, page 7) |
| ISO 10993-7 | EtO and ECH Residual | The average daily dose of EO to patient shall not exceed 4 mg;The average daily dose of ECH to patient shall not exceed 9 mg; | EO average daily dose (mg/d) < 0.006;ECH average daily dose (mg/d) < 0.03 (Test Method/Results table, page 7) |
| ASTM F1980 | Shelf-Life Validation | Meet the requirements of Level 2 barrier performance at the end of shelf-life claimed | Meet the requirements of Level 2 barrier performance after 2 years accelerated aging. The aging temperature is 60°C and the aging time is 56 days. (Test Method/Results table, page 7) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test (e.g., number of masks tested for fluid resistance). It refers to the tests being conducted per the cited ASTM, EN, and ISO standards, which would typically specify sample sizes. The data provenance is not explicitly mentioned as "country of origin of the data" or "retrospective/prospective," but the manufacturer is based in China: Hubei Huaqiang High-Tech CO., LTD., No.499 DongLin Road, Yichang, Hubei Province, 443000, China. The testing described is non-clinical performance and biocompatibility testing of the device, not a human study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of testing described in the document. The tests performed are objective, standardized laboratory tests (e.g., measuring filtration efficiency, fluid resistance) whose "ground truth" is determined by the physical properties of the device and the methodologies of the test standards, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for direct performance measurements of physical characteristics, not expert adjudication of clinical outcomes.
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 device is a medical surgical mask, not an AI-powered diagnostic tool. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the specified international and national standards (ASTM, EN, ISO, CFR) and their defined test methodologies. The results reflect the physical and biological properties of the mask as measured by accredited laboratory procedures, not by expert consensus, pathology, or outcomes data in a clinical setting.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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