Search Results
Found 1 results
510(k) Data Aggregation
(22 days)
Perfetta Moderate Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
The subject device is three-layers, flat-pleated mask constructed of nonwoven polypropylene materials, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene. The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex. A zinc wire nose piece with polypropylene coating is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose. The subject device is provided in blue color. The blue colorant is made of polypropylene master batch. This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable device, provided non-sterile.
The provided text is related to the FDA 510(k) premarket notification for a medical face mask, not an AI/ML medical device. Therefore, a direct response to your detailed questions regarding acceptance criteria, study design for AI/ML devices, and ground truth establishment is not applicable. The information describes the performance testing of a physical product (medical face mask) against established industry standards.
However, I can extract the acceptance criteria and the device's performance based on the provided document as it pertains to the Perfetta Moderate Medical Face Mask.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥29 out of 32 passed in 120 mmHg (Level 2) | ≥29 out of 32 passed in 120 mmHg (Level 2) | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% at 0.1µm | ≥98% at 0.1µm | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥98% | ≥98% | Pass |
| Differential Pressure (Delta P) | < 6 mmH2O/cm² | < 6 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 (≥ 3.5 seconds) | Class 1 (≥ 3.5 seconds) | Pass |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5) | The device is non-cytotoxic | Under the conditions of the studies, the device is non-cytotoxic. | Pass |
| Skin Sensitization (ISO 10993-10) | The device is non-sensitizing | Under the conditions of the studies, the subject device is non-sensitizing. | Pass |
| Skin Irritation (ISO 10993-23) | The device is non-irritating | Under the conditions of the studies, the device is non-irritating. | Pass |
Since this document describes a physical medical device (face mask) rather than an AI/ML-driven diagnostic or treatment device, the following questions are not directly applicable. I will indicate where the information is not present or not relevant to this type of submission.
2. Sample size used for the test set and the data provenance
- Sample size: The document states that "Performance testing were performed on three non-consecutive lots." For fluid resistance, the test involved 32 samples (≥29 out of 32 passed). For other performance attributes, the specific sample size per test, beyond "three non-consecutive lots," is not detailed but states that the sample size "is complied with ISO 2859-1, general inspection level II as FDA recommendation and acceptance quality limit (AQL) of 4%."
- Data provenance: Not explicitly stated regarding country of origin or retrospective/prospective for the testing of the device itself. The applicant and factory are based in Vietnam.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a physical product directly tested against objective, measurable performance standards (e.g., filtration efficiency, fluid resistance) defined by consensus standards (ASTM, ISO, CFR). There is no "ground truth" established by experts in the sense of interpreting medical images or data.
4. Adjudication method for the test set
- Not applicable for performance testing of a physical product against numerical standards. Results are pass/fail based on meeting the quantitative criteria.
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 not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- Not applicable in the AI/ML context. For this medical device, the "ground truth" is established by direct physical, chemical, and biological testing against predefined, objective performance standards (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration efficiency, ISO 10993 for biocompatibility).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Ask a specific question about this device
Page 1 of 1