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510(k) Data Aggregation
(226 days)
The disposable 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 provided non-sterile.
The 3-ply surgical mask is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
The provided text describes the acceptance criteria and performance study for a Surgical Mask - Level 3 & Procedure Mask - Level 3. This is a medical device (PPE), not an AI/software device, so the requested information regarding AI-specific studies (experts establishing ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this submission.
Here is the information directly relevant to the acceptance criteria and study for this physical device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device Name: Surgical Mask - Level 3 & Procedure Mask - Level 3 (K202607)
| Item | Acceptance Criteria | Reported Device Performance (Subject Device) | Predicate Device Performance | Result |
|---|---|---|---|---|
| Level 3 Fluid Resistance (ASTM F1862) | 29 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.67-99.80% | ≥99% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.6 - 99.9% | ≥99% | Pass |
| Differential Pressure (ASTM F2100) | < 6.0 mmH₂0/cm² | 4.8-5.0 mmH₂0/cm² | Avg. 3.6 mmH₂0/cm² | Pass |
| Class 1 Flammability (16 CFR 1610) | < 3.5 second burn time | Did not ignite or Ignited but Extinguished | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Under the conditions of the study the device is non-cytotoxic | Non-cytotoxic | Pass |
| Skin Sensitization (ISO 10993-10) | Non-sensitizing | Under the conditions of the study the device is non-sensitizing | Non-sensitizing | Pass |
| Skin Irritation (ISO 10993-10) | Non-irritating | Under the conditions of the study the device is non-irritating | Non-irritating | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The sample size is explicitly stated for the Level 3 Fluid Resistance test: 32 samples (32 Out of 32 pass). For the other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not explicitly provided in the summary, but the results are reported as meeting the criteria, implying sufficient samples were tested according to the respective standards.
Data Provenance: The data comes from non-clinical benchtop performance testing and biocompatibility testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying testing conducted to U.S. and international standards (ASTM, ISO). The testing is implicitly prospective, as it's conducted to demonstrate meeting the criteria for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This is a physical medical device (surgical mask), not an AI/software device that requires human experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for this device is established through standardized laboratory testing protocols of its physical properties and biological compatibility.
4. Adjudication Method for the Test Set
Not Applicable. As this is a physical device tested against established engineering and biological standards, "adjudication" in the sense of expert review for ambiguous cases is not relevant. The results are quantitative measurements against defined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are typically performed for AI or diagnostic devices where human reader performance is a key metric. This is a physical protective device. The study performed was non-clinical benchtop testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device. There is no algorithm to assess.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements from standardized laboratory tests according to recognized standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, ASTM F2100, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define the test methods and the performance criteria for surgical masks.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, there is no ground truth to establish for it.
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