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510(k) Data Aggregation
(136 days)
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 Surgical face mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of HDPE (high density polyethylene). The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The document describes a 510(k) premarket notification for a surgical face mask (K211296) submitted by Sunsmed Protective Products Ltd., seeking substantial equivalence to a predicate device (K182515) from Wuhan Dymex Healthcare Co., Ltd. The document does not describe the acceptance criteria of an AI device or a study proving an AI device meets acceptance criteria. Consequently, I am unable to provide the requested information.
The document primarily focuses on the non-clinical performance testing of the surgical face mask to demonstrate its substantial equivalence to a predicate device.
Here's the relevant information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Items | Acceptance Criteria (Level 2, ASTM F2100-19) | Reported Device Performance |
|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | ≥98 | 98.9~99.7% Pass |
| Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | 4.1~5.0 mmH2O/cm² Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥98 | 98.03~98.86% Pass |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | 29 of 32 test articles passed at 120mmHg | Test 1: 30 of 32 test articles passed at 120mmHg;Test 2: 31 of 32 test articles passed at 120mmHg;Test 3: 31 of 32 test articles passed at 120mmHg Pass |
| Flammability | Class 1 | Class 1, Non Flammable Pass |
| Biocompatibility Testing | ||
| Cytotoxicity | Device is noncytotoxic | Under the conditions of the study, the device is noncytotoxic. Pass |
| Irritation | Device is nonirritating | Under the conditions of the study, the device is nonirritating. Pass |
| Sensitization | Device is nonsensitizing | Under the conditions of the study, the device is nonsensitizing Pass |
2. Sample size used for the test set and the data provenance
The sample size is explicitly mentioned for the Resistance to penetration by synthetic blood test: 32 test articles were used. The document does not specify the sample size for other performance tests (BFE, Differential pressure, PFE, Flammability) or biocompatibility tests (Cytotoxicity, Irritation, Sensitization). The data provenance (country of origin, retrospective/prospective) is not specified for these tests, although the device manufacturer is based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests described are for a physical medical device (surgical face mask) and involve laboratory performance and biocompatibility testing, not expert- Adjudicated ground truth for an AI system.
4. Adjudication method for the test set
This information is not applicable. The context is non-clinical performance testing of a physical device, not an AI system requiring adjudication.
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 information is not applicable. The document describes testing for a surgical face mask, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The document describes testing for a surgical face mask, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established by objective laboratory testing against recognized standards (specifically ASTM F2100-19) for physical properties and biological responses. For biocompatibility, this involves standardized tests for cytotoxicity, irritation, and sensitization.
8. The sample size for the training set
This information is not applicable. There is no mention of a training set as this document describes performance testing for a physical medical device, not an AI system.
9. How the ground truth for the training set was established
This information is not applicable. There is no mention of a training set or its ground truth as this document describes performance testing for a physical medical device, not an AI system.
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