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510(k) Data Aggregation
(275 days)
The Disposable Surgical Mask are 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(s), provided sterile.
The Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.
The size of the disposable surgical mask is 17.5*9.5cm with tolerance +-5%, the length of the ear loop is 16cm with tolerance +-5%, and the length of the nose clip should no less than 8.0cm.
The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.
The document describes the non-clinical testing performed to demonstrate that the Disposable Surgical Mask (Model MP9017) manufactured by XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD meets its acceptance criteria and is substantially equivalent to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Reported Device Performance | Acceptance Criteria (Level 2) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 32 out of 32 pass at 120 mmHg | 29 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | 99.77% | ≥ 98% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | 99.7% | ≥ 98% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | 4.26 mmH2O/cm² | < 6.0 mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | PASS |
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation | Under the conditions of the study, the device is non-irritating. | Non-Irritating | PASS |
| Sensitization | Under the conditions of the study, the device is non-sensitizing. | Non-Sensitizing | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each test in the acceptance criteria table (Table 2 and 3). However:
- Fluid Resistance (ASTM F1862): The acceptance criteria and performance indicate a sample size of 32 test articles.
- Other performance tests (PFE, BFE, Differential Pressure, Flammability): The specific sample sizes for these tests are not provided.
- Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The specific sample sizes are not provided, but these tests are typically conducted in vitro or on animal models following ISO 10993 guidelines.
Data Provenance: The non-clinical tests were conducted by the manufacturer, XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD, based in China (Xiamen, Fujian). The document does not specify if the data is retrospective or prospective, but as it's part of a 510(k) submission for a new device, these would typically be newly conducted prospective tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the acceptance criteria are based on established international standards (ASTM, EN, ISO, CFR) for medical device performance and biocompatibility, not on expert consensus for a ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective laboratory measurements against defined standards, not subjective assessments requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." Surgical masks are typically evaluated through non-clinical performance and biocompatibility testing against established standards, not through studies involving human readers or comparative effectiveness with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical product (surgical mask), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the test results is based on objective measurements performed according to established international standards and test methods. For example:
- Fluid Resistance: Measured according to ASTM F1862.
- Filtration Efficiency: Measured according to ASTM F2299 (PFE) and ASTM F2101 (BFE).
- Differential Pressure: Measured according to EN 14683 Annex C.
- Flammability: Measured according to 16 CFR 1610.
- Biocompatibility: Evaluated according to ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical surgical mask and does not involve an AI algorithm that requires a training set. The term "training set" is relevant for AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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