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The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. This face mask 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 provided non-sterile.

Disposable Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth to protect the wearer from microorganisms, body fluids and particulates. Disposable Surgical Mask consists of the following materials: Non-woven cloth in the front and back layers, melt-blown cloth in the middle layer, a nose clip and two ear loops in Spandex. The Disposable Surgical Masks are provided non-sterile.

The provided document is a 510(k) premarket notification for a Disposable Surgical Mask (K210267). It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Disposable Surgical Mask, K210267) is a surgical mask intended to meet Level 2 performance according to ASTM F2100:2019. The acceptance criteria and the device's reported performance are summarized in the table below:

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

• Sample Size for Performance Tests: For performance tests like Synthetic Blood Penetration, Flammability, Differential Pressure, Bacterial Filtration Efficiency, and Latex Particle Challenge, a sample size of 32/32 was used as indicated by "32/32 Passed" in the results.
• Sample Size for Biocompatibility Tests: The document doesn't explicitly state the exact sample size (number of devices or extracts) used for the biocompatibility tests (Cytotoxicity, Irritation, Sensitization). It only states "Under the conditions of the study, the subject device extract was determined to be..."
• Data Provenance: The tests were conducted in a lab ("Samples submitted to the testing lab"). The document does not specify the country of origin of the lab or if the data is retrospective or prospective, beyond saying the tests were conducted to verify the proposed device met design specifications. These are non-clinical (laboratory) studies, not human subject studies.

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

• This information is not applicable for this submission. The "ground truth" for the performance tests of a surgical mask is established by validated standardized test methods (e.g., ASTM, EN, ISO standards) and their predefined pass/fail criteria, not by expert consensus on clinical findings. Biocompatibility assessment is also based on established in-vitro and in-vivo biological evaluation standards.

4. Adjudication Method for the Test Set

• This is not applicable. As the evaluation involved standardized performance and biocompatibility laboratory tests, there was no need for an adjudication method by human experts. The results are quantitative and compared against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• This is not applicable. This is a 510(k) submission for a physical medical device (Disposable Surgical Mask), not an AI/software device. No MRMC comparative effectiveness study was performed or required.

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

• This is not applicable. This is a physical medical device; there is no algorithm or human-in-the-loop component.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is based on standardized test methods and their defined pass/fail criteria. For example:
  • Performance: Measured values (e.g., pressure, filtration efficiency, burn time) are compared against the numerical criteria specified in ASTM F2100 Level 2, 16 CFR Part 1610, and EN 14683.
  • Biocompatibility: Biological responses (e.g., cell viability, skin reactions) are assessed against the criteria for "non-cytotoxic," "non-irritating," and "non-sensitizing" as outlined in ISO 10993 standards.

8. The Sample Size for the Training Set

• This is not applicable. Since no AI or machine learning model is involved, there is no "training set."

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

• This is not applicable. As there is no training set.

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