Search Results
Found 1 results
510(k) Data Aggregation
(199 days)
This device is intended for single use by operating room personnel healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluid, and particulate materials.
The device is single use multi-layer surgical mask with outer layer and inner layer (spunbond plypropylene) that sandwich a meltblown polypropylene filter material. The surgical mask is secured on user via earloops. Earloops are made of polyester and spandex. The nose piece is a plastic covered iron strip. The materials used to make the surgical mask are being used in currently marketed surgical masks.
The provided text describes the acceptance criteria and performance of the CiRx® Surgical Mask based on non-clinical testing. It does not mention any studies involving AI, human readers with or without AI assistance, or the creation of ground truth by experts in a clinical context. Therefore, many of the requested fields cannot be filled from the given document.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Performance Test (Test Methodology) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Synthetic Blood Penetration Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | Pass at 160 mmHg. Synthetic blood penetration was not seen. Four lots were tested, with 32 out of 32 passing for each lot. |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% | Pass, ≥ 99.7%. Four lots were tested. |
| Particle Filtration Efficiency (PFE) (ASTM F2299) | ≥ 98% | Pass, ≥ 99.814%. Four lots were tested. |
| Differential Pressure (Delta P) (ASTM F2100-19) | < 5.0 mmH2O/cm2 | Pass, ≤ 4.9 mmH2O/cm2. Four lots were tested. |
| Flammability (16 CFR 1610) | Class 1 | Pass. Four lots were tested. |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | No cytotoxicity | No cytotoxicity |
| Biocompatibility (ISO 10993-10) | No sensitization | No sensitization |
| Biocompatibility (ISO 10993-10) | No irritation | No irritation |
2. Sample size used for the test set and the data provenance:
- Synthetic Blood Penetration Resistance: 32 samples per lot, tested across four lots (total of 128 samples).
- Bacterial Filtration Efficiency (BFE): Four lots were tested. The exact number of individual mask samples per lot for BFE, PFE, and Differential Pressure is not specified, but it's implied that multiple samples were tested to achieve the reported averages.
- Particle Filtration Efficiency (PFE): Four lots were tested.
- Differential Pressure (Delta P): Four lots were tested.
- Flammability: Four lots were tested.
- Biocompatibility: The document does not specify the sample size for biocompatibility testing, but it refers to ISO 10993 standards which would guide the sample selection.
- Data Provenance: The tests were conducted to demonstrate that the device met established standards and specifications. The document does not specify the country of origin of the testing data, but the manufacturer is Ningbo Shun Ye Medical Company, Ltd. in China. The nature of the tests (laboratory performance tests for surgical masks) makes the "retrospective or prospective" distinction less applicable than in clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests are laboratory performance tests against established international standards for surgical masks. Ground truth is determined by the results of these standardized physical and biological tests, not by expert consensus on clinical findings.
4. Adjudication method for the test set:
Not applicable. As these are objective laboratory tests, there is no adjudication method in the context of expert review. The results are compared directly against predefined acceptance criteria from international standards.
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:
No. The document describes a surgical mask, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a surgical mask, not an algorithm.
7. The type of ground truth used:
The ground truth is based on the results of standardized laboratory performance tests, which are objective measurements against established international and national standards (e.g., ASTM, ISO, CFR).
8. The sample size for the training set:
Not applicable. This document describes the performance of a physical medical device (surgical mask), not a machine learning algorithm. Therefore, 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 a physical surgical mask.
Ask a specific question about this device
Page 1 of 1