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510(k) Data Aggregation
(337 days)
The TOPWIDE surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.
The Topwide surgical face mask is with white color outer laver and white inner layer. Subject device is a Flat Pleated type mask, utilizing ear-loop way for wearing, and it has a nose piece design for fitting the facemask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner laver (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask has Level II fluid resistance under ASTM F2100. The mask is a single use, provided non sterile. This product contains no components made with natural rubber latex.
The provided document is a 510(k) summary for a Topwide Surgical Face Mask (K210102). It details the device's characteristics and its equivalence to a predicate device, based on non-clinical performance testing.
It is crucial to understand that this document describes a surgical face mask, not an AI-powered medical device or software. Therefore, the questions related to AI-specific elements like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "number of experts used to establish ground truth," "adjudication method," and "training set details" are not applicable to this type of device and the information provided.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical performance testing of the mask against established ASTM and ISO standards for medical face masks.
Here's the breakdown of the acceptance criteria and performance based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Test Methodology, Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration by synthetic blood | 120 mm Hg | 120 mm Hg (32 out of 32 pass) |
| ASTM F2299 | Particulate filtration efficiency (PFE) | $\ge$ 98% | $\ge$ 99.78% (>99% for predicate) |
| ASTM F2101 | Bacterial filtration efficiency (BFE) | $\ge$ 98% | $\ge$ 98% (Same as predicate: >99%) |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |
| ASTM F2100 | Differential Pressure (Delta-P) (Breathability) | < 6.0 mm H2O/cm$^2$ | 2.94 mm H2O/cm$^2$ (<28.8 Pa/cm$^2$) |
| ISO 10993-5, ISO 10993-10 | Biocompatibility (Cytotoxicity, Irritation, Sensitization) | Not cytotoxic, irritating, or sensitizing under the conditions of the studies | PASSED |
Note: The document sometimes lists the predicate device's performance for comparison and sometimes the subject device's. I have focused on the subject device's reported performance where available and clearly distinguishable from the predicate's, and noted similarities where appropriate.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions that performance data was "provided from 3 nonconsecutive lots." For Fluid resistance (ASTM F1862), it explicitly states "32 out of 32 pass." This implies a sample size of 32 units tested for this specific criterion, drawn from the 3 nonconsecutive lots. The exact sample sizes for other tests are not individually specified but would typically involve multiple units from those 3 lots to demonstrate consistency.
- Data Provenance: The manufacturer is "Topwide (Hubei) Medical Products Manufacturer" located in Xiantao, Hubei, China. The data would therefore be laboratory test results conducted presumably in China, either by the manufacturer or a contracted testing facility. The data is retrospective in the sense that it was collected as part of the product development and validation before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a medical device (surgical face mask) that undergoes physical and chemical performance testing, not diagnostic or image-based AI software requiring expert human interpretation for ground truth. The "ground truth" here is the result of standardized test methods, not expert consensus on medical images.
4. Adjudication method for the test set
Not Applicable. As explained above, this is directly measured physical and chemical performance, not a subjective assessment requiring adjudication among multiple human readers. The results are quantitative and objective measurements from laboratory tests.
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 study is for a physical medical device (surgical face mask), not an AI-powered diagnostic tool. There are no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an algorithm or software. It is a physical product.
7. The type of ground truth used
The ground truth used for this product is based on objective measurements obtained from standardized laboratory testing methods against established national and international standards (ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR 1610, ASTM F2100, ISO 10993-5, ISO 10993-10). These standards define the specific parameters and methodologies for assessing performance attributes like fluid resistance, filtration efficiency, breathability, flammability, and biocompatibility.
8. The sample size for the training set
Not Applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The product's design and manufacturing processes are refined through engineering and material science, not data training.
9. How the ground truth for the training set was established
Not Applicable. There is no training set for this type of device. The "ground truth" for ensuring the product's quality and performance is established by adhering to manufacturing specifications and testing against the performance standards mentioned in point 7.
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