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510(k) Data Aggregation
(140 days)
The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
The Sparta 3-Ply Surgical Disposable Face Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with three layers: Outer Layer: Spunbond polypropylene, Middle Layer: Melt Blown polypropylene, Inner Layer: Spunbond polypropylene. The subject device is provided non-sterile and is a single use, disposable device.
The Sparta 3-Ply Surgical Disposable Face Mask is intended to protect both patients and healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. It's designed for single use, non-sterile, and disposable applications in infection control practices. The device was deemed substantially equivalent to the predicate device, Disposable Surgical Mask K202463.
Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Characteristic | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (Subject Device) | Comparison Analysis |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-13) | Not publically available (implicitly met by predicate) | 96 Passed (3 batches of 32) | Substantially Equivalent |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 99% | ≥98% | Substantially Equivalent |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 0.999 (implicitly 99.9%) | Substantially Equivalent |
| Differential Pressure (Delta P) (EN 14683) | < 6.0 mm H2O/cm^2 | <6.0 mmH^2O/cm^2 | Modified - Both the predicate and the subject device passed as per the Standard. No additional concerns related to efficacy are presented. |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Identical |
| Cytotoxicity (ISO 10993-5, ISO 10993-12) | Non-cytotoxic | Non-cytotoxic | Identical |
| Irritation (ISO 10993-10, ISO 10993-12) | Non-irritating | Non-irritating | Identical |
| Sensitization (ISO 10993-10, ISO 10993-12) | Non-sensitizing | Non-sensitizing | Identical |
| Dimensions - Width | 9.5cm ± 2cm (3.74" ± 0.40") | 3.74in (95 mm) | Substantially Equivalent - Subject device is within range of the predicate device. |
| Dimensions - Length | 17.5cm ± 2cm (6.89" ± 0.40") | 6.89in (175 mm) | Substantially Equivalent - Subject device is within range of the predicate device. |
| ASTM F2100 Level | Level 3 | Level 3 | Identical |
2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes or data provenance in terms of country of origin for the performance tests. However, for specific tests, some sample details are provided:
- Fluid Resistance Performance (ASTM F1862-13): "96 Passed (3 batches of 32)". This indicates a total of 96 samples were tested across 3 batches, with each batch having 32 samples.
- For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, and Biocompatibility (Cytotoxicity, Irritation, Sensitization), the sample sizes are not explicitly stated in the provided text. The tests were performed by "INTERTEK-Complete" as indicated in the file names (ATT-18-1_Test_RESULTS-Performance-INTERTEK-Complete). The provenance of this testing (e.g., country of origin of the lab) is not mentioned.
The studies were non-clinical bench tests and biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is typically not applicable to objective performance testing of surgical masks according to recognized standards (ASTM, EN, ISO). The "ground truth" is established by the test method defined in the standard itself, which provides objective measurements (e.g., percentage filtration, pressure drop). There is no mention of experts establishing ground truth for these types of tests in the provided document.
4. Adjudication method for the test set
Not applicable. As described above, the acceptance is based on objective measurements against predefined standards, not expert adjudication of subjective assessments.
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 is a surgical face mask, not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (surgical face mask), not an algorithm or software.
7. The type of ground truth used
For the performance and biocompatibility tests, the ground truth is based on:
- Standardized test methods: Each test (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 series) defines the methodology and criteria for performance assessment.
- Objective measurements: The results are derived from quantitative and qualitative measurements according to these standards (e.g., filtration percentages, pressure values, observation of biological reactions).
8. The sample size for the training set
Not applicable. This is a physical medical device, not a 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 for this type of device.
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