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510(k) Data Aggregation
(167 days)
The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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(s), provided non sterile.
The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with tie on and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. During use, the tie on shall be tied over user head. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.
The provided text is a 510(k) Summary for a Disposable Surgical Face Mask, which is a medical device. This document describes the non-clinical testing performed to demonstrate that the device meets specific performance criteria, primarily based on recognized standards for surgical masks.
It is crucial to understand that this document DOES NOT describe a study involving AI, human readers, or image analysis. Instead, it focuses on the physical and biological characteristics of a surgical mask. Therefore, many of the requested points regarding AI/human reader studies are not applicable to the information contained in this document.
Here's an analysis based on the provided text, addressing the applicable points:
Acceptance Criteria and Device Performance (for a Disposable Surgical Face Mask)
This document details acceptance criteria and performance for a surgical face mask, not an AI-based device.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Performance (Reported Device Performance) | Acceptance Criteria (Level 3, ASTM F2100-19) | Result |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | >98% | ≥98 | Pass |
| Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | >98% | ≥98 | Pass |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | 31 of 32 test articles passed at 160mmHg | 29 of 32 test articles passed at 160mmHg | Pass |
| Flame spread | Class 1 | Class 1 | Pass |
Biocompatibility Testing
| Item | Proposed Device (Reported Device Performance) | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device is nonsensitizing. | Pass |
Since this document pertains to a physical medical device (a surgical mask) and not an AI/software device, the following points are not applicable (N/A) based on the provided text.
2. Sample size used for the test set and the data provenance:
N/A - This document describes testing on physical samples of surgical masks, not a data-driven test set for a software/AI device. The text indicates "31 of 32 test articles passed" for the synthetic blood penetration test, which implies a test sample size of 32 masks for that specific test. Data provenance like country of origin for the data is not relevant here as it's about physical product testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A - Ground truth for a physical device like a surgical mask is established by validated laboratory test methods and compliance with recognized standards (e.g., ASTM F2100-19), not by expert consensus in a medical imaging context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A - Adjudication methods are relevant for subjective assessments, typically in medical imaging or clinical trials where human interpretation is involved. This is laboratory testing of a physical product.
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:
N/A - This device is a surgical mask, not an AI system. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A - As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth/acceptance criteria for the surgical mask performance is based on recognized industry standards (ASTM F2100-19) and guidelines for medical devices (ISO 10993 for biocompatibility), which specify quantitative and qualitative outcomes for the physical and biological properties of the mask.
8. The sample size for the training set:
N/A - There is no "training set" as this is not an AI/machine learning device. The document describes product manufacturing and testing.
9. How the ground truth for the training set was established:
N/A - No training set.
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