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When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.

Subject Device (3 Layer Surgical Mask) is single use, 3 layers, flat-pleated style face mask with ear loops and moldable nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains polyester / spandex blend ear loops to secure the mask over the user's face and mouth with moldable nose piece to firmly fit over the nose.

Acceptance Criteria and Device Performance for 3 Layer Surgical Mask

The provided document describes the acceptance criteria and the study that proves the device, a "3 Layer Surgical Mask," meets these criteria. The study focuses on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask, K202595).

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 tests (Fluid Resistance, PFE, BFE, Flammability, Differential Pressure), the testing was conducted on three lots of the subject device. For fluid resistance, each lot involved testing 32 samples. Specific individual sample sizes for other tests within each lot are not explicitly stated but are implied to be sufficient for compliance with the specified ASTM/EN standards.
  • For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the evaluations were performed on the "Proposed Device" (subject device). The specific number of individual samples or test subjects (e.g., cell cultures, rabbits, guinea pigs) used for these ISO 10993 tests is not detailed in the summary, but the results indicate compliance with the standards, which typically specify sample sizes.
• Data Provenance: The document states "Subject device has been evaluated for safety and performance by lab bench testing according to the following standards". This indicates the data is from prospective bench testing conducted in a laboratory setting for the purpose of this 510(k) submission. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, implying the tests were conducted by a lab that provides data acceptable to the FDA, likely within the US or an equivalent regulatory standard.

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

• This submission relies on non-clinical bench testing and biocompatibility testing against established industry standards (ASTM, EN, ISO). Ground truth in this context is established by the specified performance thresholds defined within these standards, not by human expert interpretation of medical images or patient outcomes. Therefore, the concept of "experts establishing ground truth for a test set" as it relates to clinical diagnosis or interpretation is not applicable here. The "experts" would be the certified laboratory personnel who conducted the tests according to the defined protocols. Their qualifications would be compliance with the respective standard operating procedures and laboratory accreditation.

4. Adjudication Method for the Test Set

• Not applicable. As this is non-clinical bench testing against predefined objective criteria in standards, there is no human-in-the-loop diagnostic task requiring adjudication. The results are quantitative measurements or pass/fail determinations based on material properties and performance.

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

• No MRMC comparative effectiveness study was done. The document explicitly states: "There were no clinical studies performed or included in this submission." This device is a surgical mask, and its regulatory submission is based on bench testing of its physical properties and biocompatibility, not on a diagnostic algorithm requiring human interpretation or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No standalone algorithm performance study was done. This device is a physical medical device (surgical mask), not an AI algorithm. Therefore, "algorithm only performance" is not relevant.

7. The Type of Ground Truth Used

• The ground truth used is based on defined performance standards and specifications from recognized organizations (e.g., ASTM, EN, ISO). These standards specify the methodology for testing and the quantitative/qualitative criteria that must be met. For example:
  • Fluid Resistance: >29/32 pass at 120 mmHg.
  • Filtration Efficiency (PFE & BFE): ≥ 98%.
  • Flammability: Class 1.
  • Differential Pressure: < 6.0 mmH2O/cm².
  • Biocompatibility (Cytotoxicity, Irritation, Sensitization): Non-cytotoxic, non-irritant, non-sensitizing outcomes based on specific grading scales within the ISO standards.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI model that requires a training set. The device itself is manufactured, and its properties are assessed against pre-defined standards.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for an AI model.

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