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510(k) Data Aggregation
(25 days)
The Freudenberg Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This 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, disposable device provided non-sterile.
The Freudenberg Surgical Mask is composed of three-layers and is flat-pleated. The Freudenberg Surgical Mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), and inner cover web (polypropylene spunbond, white). Each mask contains polyester spandex blend ear loops to secure the mask over the user's mouth and nose and includes a polyethylene coated wire nosepiece to provide a firm fit over the nose. This face mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.
This document is a 510(k) Premarket Notification for a Freudenberg Surgical Mask, not an AI/ML medical device. Therefore, the information requested about acceptance criteria and study data for an AI/ML device is not present in this document. This document pertains to the physical and performance characteristics of a surgical mask, compared to a predicate surgical mask.
However, I can extract the acceptance criteria and performance data for the surgical mask as presented in the document.
Here's the information about the surgical mask:
1. A table of acceptance criteria and the reported device performance
The document compares the "Proposed Device (K210063) Freudenberg Surgical Mask" to a "Predicate Device (K182514) SURGICAL FACE MASK" based on several performance metrics. The acceptance criteria for the proposed device are implicitly defined by meeting or exceeding the performance of the predicate device and conforming to relevant ASTM/EN standards, particularly for Level 3 categorization.
| Performance Metric | Acceptance Criteria (ASTM/EN Standard or Predicate Performance) | Reported Device Performance (Freudenberg Surgical Mask - K210063) |
|---|---|---|
| Fluid Resistance | Predicate: 32/32 passed at 120 mmHg - ASTM F1862. Goal: Exceed predicate/meet Level 3 (160 mmHg, AQL 4.0). | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg - ASTM F1862.Lot 698002: 31/32 passedLot 697715: 32/32 passedLot 697944: 31/32 passed(Comment: "Similar, subject device exceeded fluid resistance of predicate device") |
| Bacterial Filtration Efficiency (BFE) | Predicate: pass at 99.6% - ASTM F2101. Goal: ≥98% (for Level 3 per ASTM F2100-19) | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98% - ASTM F2101.Lot 698002: 32/32 passed at 99.9%Lot 697715: 32/32 passed at 99.9%Lot 697944: 32/32 passed at 99.9%(Comment: "Similar, both devices meet ASTM F2101") |
| Particulate Filtration Efficiency (PFE) | Predicate: pass at 99.88% - ASTM F2299. Goal: ≥98% (for Level 3 per ASTM F2100-19) | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98% - ASTM F2299.Lot 698002: 32/32 passed at 99.6±0.1%Lot 697715: 32/32 passed at 99.5±0.1%Lot 697944: 32/32 passed at 99.7±0.1%(Comment: "Similar, both devices meet ASTM F2299") |
| Differential Pressure (Delta P) | Predicate: pass at 3.0 mmH₂O/cm² - MIL-M036954C. Goal: <6.0 H₂O/cm² (for Level 3 per ASTM F2100-19 / EN 14683:2019, Annex C) | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at <6.0 H₂O/cm² - ASTM F2100 / EN 14683:2019, Annex C.Lot 698002: 29/32 passed at 5.3mm H₂O / cm²Lot 697715: 30/32 passed at 5.3mm H₂O / cm²Lot 697944: 31/32 passed at 5.7mm H₂O / cm²(Comment: "Similar, subject device utilized ASTM F2100-19 test methods") |
| Flammability | Predicate: Class 1 16 CFR 1610. Goal: Class 1 16 CFR 1610. | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed Class 1 16 CFR 1610.Lot 698002: 32/32 passedLot 697715: 32/32 passedLot 697944: 32/32 passed(Comment: "Same") |
| Biocompatibility - Cytotoxicity | Predicate: non-cytotoxic. Goal: non-cytotoxic (ISO 10993-5). | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.(Comment: "Same") |
| Biocompatibility - Irritation | Predicate: non-irritating. Goal: non-irritating (ISO 10993-10). | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.(Comment: "Same") |
| Biocompatibility - Sensitization | Predicate: non-sensitizing. Goal: non-sensitizing (ISO 10993-10). | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing.(Comment: "Same") |
2. Sample size used for the test set and the data provenance
- Sample Size for performance testing: For fluid resistance, BFE, PFE, differential pressure, and flammability, 96 samples were tested (3 non-sequential lots of 32 samples each, with an Acceptable Quality Level (AQL) of 4.0).
- Sample Size for biocompatibility: The document does not specify the exact number of samples for biocompatibility testing, but it refers to "the study" for each of cytotoxicity, irritation, and sensitization, indicating that tests were conducted. Biocompatibility tests usually involve a small number of samples but are well-controlled in vitro or in vivo studies.
- Data Provenance: Not explicitly stated, but based on the nature of medical device testing for FDA clearance, it would be prospective testing conducted in controlled laboratory environments. The country of origin of the data is not specified, but the applicant's address is in Durham, NC, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a physical surgical mask, not an AI/ML medical device requiring expert interpretation for ground truth establishment. The performance is measured against established physical and biological standards (e.g., fluid penetration, filtration efficiency, flammability, biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for a physical device. Performance is determined by objective laboratory measurements and adherence to specified test methods (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE).
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
This section is not applicable as the device is a physical surgical mask and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical surgical mask and does not involve algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective, internationally recognized laboratory test standards and methods for material performance, filtration, and biocompatibility, such as:
- ASTM F2100 (Standard Specification for Performance of Materials Used in Medical Face Masks) - defines performance levels.
- ASTM F1862 (Resistance to Penetration by Synthetic Blood)
- ASTM F2299 (Efficiency to Penetration by Particulates Using Latex Spheres)
- ASTM F2101 (Bacterial Filtration Efficiency)
- EN 14683 (Differential Pressure)
- 16 CFR Part 1610 (Flammability)
- ISO 10993-1, ISO 10993-5, ISO 10993-10 (Biocompatibility: Cytotoxicity, Irritation, Sensitization)
8. The sample size for the training set
This section is not applicable as the device is a physical surgical mask and does not involve AI/ML models requiring training data.
9. How the ground truth for the training set was established
This section is not applicable as the device is a physical surgical mask and does not involve AI/ML models requiring training data.
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