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510(k) Data Aggregation
(115 days)
The Surgical Face Masks 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 non-sterile.
The Surgical Face Masks are blue color, single use, flat-folded masks with nose piece and ear loops or tie-on. The blue colorant is polypropylene (PP) master batch.
The Surgical Face Masks are manufactured with 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The tie-on is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text is a 510(k) summary for a Surgical Face Mask. It describes the device, its intended use, and the non-clinical tests conducted to demonstrate its substantial equivalence to a predicate device.
Here's the information extracted and organized as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria: ASTM F2100 Level 3 | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance | Demonstrate functionality of the subject device. | 29 out of 32 pass at 160 mmHg for Level 3 | 32 out of 32 pass at 160 mmHg |
| Particulate Filtration Efficiency | ≥ 98% | 99.4% | |
| Bacterial Filtration Efficiency | ≥ 98% | 99.9% | |
| Differential Pressure | < 6.0 mmH2O/cm² | 3.1 mmH2O/cm² | |
| Flammability | Class 1 | Class 1 | |
| Cytotoxicity | Demonstrate the safety of the subject device. | Non-cytotoxic | Non-cytotoxic (under study conditions) |
| Irritation | Demonstrate the safety of the subject device. | Non-irritating | Non-irritating (under study conditions) |
| Sensitization | Demonstrate the safety of the subject device. | Non-sensitizing | Non-sensitizing (under study conditions) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Fluid Resistance: 32 samples were tested.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It refers to non-clinical tests conducted to verify the device met design specifications and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the tests performed are non-clinical (laboratory tests) and do not involve human diagnostic assessment or ground truth established by experts in the context of clinical scenarios.
4. Adjudication Method for the Test Set
This section is not applicable as the tests performed are non-clinical laboratory tests and do not involve human adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."
6. Standalone Performance Study
Yes, a standalone performance study was done in the form of non-clinical laboratory testing. The device's performance was evaluated against established standards for medical face masks (ASTM F2100 Level 3). The results in the table above represent the algorithm-only performance against these standards, as there is no human-in-the-loop for these types of tests.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests is established by industry standards and regulatory requirements, specifically ASTM F2100, ISO 10993-5, ISO 10993-10, ASTM F1862, EN 14683, ASTM F2101, ASTM F2299, and 16 CFR 1610. These standards define the quantitative and qualitative acceptance criteria for the performance and safety characteristics of surgical face masks.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (Surgical Face Mask), not an AI algorithm or software. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would relate to production batches, but not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8; there is no training set mentioned for this medical device.
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