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The Hygenix is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms. body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.

The Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PC coated Aluminium wire. The model ear loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of Polyester and Spandex. The dimensions of the Mask are: length- 175 ± 5 mm and width- 95 ± 5 mm. These masks are single-use, disposable devices, provided non-sterile.

Here's an analysis of the Hygenix device based on the provided FDA 510(k) summary, specifically focusing on its acceptance criteria and the study that proves it meets those criteria.

Acceptance Criteria and Device Performance for Hygenix (K232797)

The Hygenix device is a 3-ply disposable mask, and its performance is evaluated against established standards for surgical masks. The study proving its compliance is a non-clinical performance and biocompatibility testing regime.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes used for each individual performance test (fluid resistance, PFE, BFE, etc.) or biocompatibility test. However, these are standard laboratory tests conducted on samples of the device materials and/or finished products as per the referenced ASTM, EN, and ISO standards.

The data provenance is from non-clinical laboratory testing. The country of origin of the data is not explicitly stated, but the manufacturer is Shenzhen Hygenix Industrial Co., Ltd, located in China. Therefore, it is highly probable the testing was conducted in laboratories associated with the manufacturer or in accredited testing facilities, potentially in China or other regions adhering to these international standards. This data is prospective in the sense that it evaluates the manufactured device against pre-defined criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of testing (performance and biocompatibility for a surgical mask) does not involve experts establishing a "ground truth" in the way a clinical study with medical image interpretation would. The "ground truth" for these tests is defined by the objective, quantitative measurements obtained through standardized laboratory protocols as outlined in the referenced ASTM, EN, and ISO standards. The results are compared against the numerical acceptance criteria specified in those standards. The expertise lies in the certified laboratory technicians and scientists performing the tests and interpreting the results within the framework of these internationally recognized standards.

4. Adjudication method for the test set

There is no formal "adjudication method" in the sense of multiple expert reviewers. The tests are designed to produce objective, measurable results. The "adjudication" is inherent in the adherence to the detailed methodologies prescribed by the relevant standards (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE). A test result either objectively meets or fails the specified numerical acceptance criterion.

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 device is a surgical mask, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (surgical mask), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for evaluating the Hygenix mask's performance and biocompatibility is based on:

• Objective, quantitative measurements obtained from standardized laboratory tests (e.g., filtration percentages, differential pressure values, flammability class).
• Established biological endpoints for biocompatibility (e.g., absence of cytotoxicity, irritation, or sensitization), as defined by ISO standards and assessed through specific in-vitro and in-vivo (e.g., skin patch) testing.

These are not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on the empirical results of validated scientific and engineering tests.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The evaluation methodology is based on physical and chemical testing, not machine learning.

9. How the ground truth for the training set was established

Not applicable. As stated in point 8, there is no training set for this type of device.

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