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510(k) Data Aggregation
(501 days)
"Skypro, SP02 Mask (Level 3)" 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 infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.
"Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Skypro, SP02 Mask (Level 3)
Product Code: FXX
Regulation Name: Surgical apparel
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Test: | To determine if the mask may cause adverse biological reactions. | ||
| Cytotoxicity Test (MEM Elution) | To determine if the mask may cause cytotoxic effects. | Non-cytotoxic | Non-cytotoxic |
| Sensitization Test (Kligman Max) | To determine if the mask may cause skin sensitization. | Non-sensitizing | Non-sensitizing |
| Primary Skin Irritation Test | To determine if the mask may cause skin irritation. | Non-irritating | Non-irritating |
| Fluid Resistance Test | To determine the capability of mask to resist the penetration of fluids. | Pass @ 160 mmHg | Pass |
| Particle Filtration Efficiency | To measure the filtration efficiency of mask for particulates. | ≥ 98% | 98.59% |
| Bacterial Filtration Efficiency | To measure the filtration efficiency of mask for bacteria. | ≥ 98% | 99.24% |
| Differential Pressure (Delta P) | To measure how easily air is passed, an indicator of air permeability or breathability. | < 6 mmH2O/cm² | 4.04 mmH2O/cm² |
| Flammability Test | To determine if the mask ignites easily when exposed to or used near fire or heat. | Class 1 | Class 1 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of masks tested for fluid resistance, number of animals for biocompatibility). It only states that "non-clinical tests" were performed.
The data provenance is not explicitly stated in terms of country of origin of the data or whether the studies were retrospective or prospective. However, given that these are performance tests for a medical device submitted to the FDA, they are generally conducted prospectively according to established laboratory standards (e.g., GLP for biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. The tests performed are objective, quantitative laboratory tests (e.g., measuring filtration efficiency, pressure, or observing biological reactions) against defined standards. Therefore, "experts to establish ground truth" in the way one might for diagnostic imaging or clinical interpretation is not relevant here. The ground truth is established by the specified test methods and their measurable outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the tests are objective laboratory measurements, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Test: No clinical testing was performed." These are non-clinical, laboratory performance tests of a surgical mask.
Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to this device. The Skypro, SP02 Mask (Level 3) is a physical surgical mask, not an AI algorithm or a device with a software component that would involve standalone algorithm performance or human-in-the-loop performance.
7. The Type of Ground Truth Used
The ground truth for the performance tests is established by:
- Defined ASTM/ISO/FDA recognized test standards and methodologies: These standards provide objective measurement protocols and criteria (e.g., for biocompatibility, filtration, flammability).
- Quantitative measurements: For tests like Particle Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure, the results are numerical values obtained from calibrated equipment.
- Qualitative observations against predefined criteria: For biocompatibility, the outcomes are "non-cytotoxic," "non-sensitizing," and "non-irritating," which are determined by observing biological responses in accordance with test protocols.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical product (surgical mask), not an AI/ML algorithm or a system that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As mentioned above, there is no training set for this type of device.
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