Search Results
Found 1 results
510(k) Data Aggregation
(158 days)
The Disposable Medical Surgical Mask is 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 a single use, disposable device(s), provided sterile.
The Disposable Medical Surgical Mask is composed of mask body, nose clip and ear loop. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.
The size of the Disposable Medical Surgical Mask is 17.5*9.5cm with tolerance +/- 0.2cm, the length of the ear loop is 17cm with tolerance +/-5 cm, and the length of the nose clip should no less than 8.0cm.
The outer layer of Disposable Medical Surgical Mask will be provided in blue, the inner layer of the Disposable Medical Surgical Mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.
This document describes the premarket notification for a Disposable Medical Surgical Mask. It does not contain information about an AI/ML powered device, so I cannot answer your questions as they pertain to the criteria for AI/ML powered medical devices.
The document discusses the substantial equivalence of the proposed device to a legally marketed predicate device, focusing on material composition, intended use, and performance characteristics consistent with surgical masks.
However, I can extract the acceptance criteria and performance results for this non-AI medical device.
1. A table of acceptance criteria and the reported device performance
| Item | Proposed device | Acceptance Criteria (level 2) | Result |
|---|---|---|---|
| Fluid Resistance PerformanceASTM F1862 | 32 out of 32 pass at120 mmHg | 29 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration EfficiencyASTM F2299 | 99.9% | ≥ 98% | PASS |
| Bacterial Filtration EfficiencyASTM F2101 | 99.9% | ≥ 98% | PASS |
| Differential Pressure (Delta P)EN 14683 Annex C | 3.26 mmH2O/cm² | < 6.0mmH2O/cm² | PASS |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | PASS |
Biocompatibility Comparison
| Item | Proposed device | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditions of the study,the device is non-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation | Under the conditions of the study,the device is non-irritating. | Non-Irritating | PASS |
| Sensitization | Under the conditions of the study,the device is non-sensitizing | Non-Sensitizing | PASS |
The following questions cannot be answered from the provided text, as the document pertains to a medical device (surgical mask) that is not AI/ML-powered:
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Ask a specific question about this device
Page 1 of 1