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The Puravita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Puravita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device that is provided non-sterile.

The PuraVita Medical Fold Flat Surgical Mask is a 4-layer, two panel fold-flat surgical mask. It is comprised of polypropylene spunbond inner and outer layers and two inner polypropylene meltblown filter layers. The mask is white with an extended chamber. The dimensions of each mask are length 16.3cm ± 0.5cm and width 10.6cm ± 0.5cm. The mask has nylon/spandex earloops (length 19.5cm ± 1cm) and a malleable, metal-core nosepiece (0.4cm x 8.2cm x 0.1cm) to provide a functional fit over the nose and mouth of the user. It is a non-sterile, single use, disposable device. This device is not made with natural rubber latex.

This information describes the testing and acceptance criteria for a medical face mask, not an AI/ML powered device. As such, many of the typical questions regarding AI/ML device testing (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable.

Below is a summary of the requested information based on the provided document, focusing on the relevant acceptance criteria and the studies performed for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: For performance testing (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Flammability, Resistance to Penetration by Synthetic Blood), 32 samples from 3 non-sequential lots (total of 96 samples) of the Puravita Medical Fold Flat Surgical Mask were tested. For biocompatibility testing, the sample sizes were:
  • Cytotoxicity: 1 mask (components tested as composite from Lot No. 12142020A)
  • Sensitization: 6 masks (components tested as composite from Lot No. 12142020A)
  • Intracutaneous Reactivity: 2 masks (components tested as composite from Lot No. 12142020A)
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. However, based on the context of FDA submission, these are typically prospective, laboratory-based bench tests conducted by qualified testing facilities to regulatory standards. The predicate device information was obtained from FDA's public database.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This is not applicable for this type of medical device submission. The "ground truth" for these tests is established by adhering to recognized international and national standards (e.g., ASTM, ISO, EN, 16 CFR). The tests are objective measurements of physical properties and biological responses, not subjective interpretations by human experts in a clinical context. The results are quantitative (e.g., filtration efficiency percentages, pressure values, burn times) or qualitative (e.g., pass/fail for cytotoxicity, presence/absence of irritation) against defined scientific criteria.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the tests involve objective measurements against predefined acceptance criteria from recognized standards, not subjective assessments requiring adjudication by multiple experts.

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 physical medical mask, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical medical mask, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on established regulatory and industry standards for performance and safety:

• Quantitative measurements against specified thresholds (e.g., filtration efficiency percentages, differential pressure values, burn times).
• Qualitative biological responses observed in controlled laboratory settings (e.g., non-cytotoxic, non-sensitizing, non-irritating) defined by specific protocols.
• The "pass/fail criteria" for each test, as detailed in the Acceptance Criteria column of the table, represent the ground truth for acceptability.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product and does not involve training data for an algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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