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The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.

Dukal Surgical Masks are pleated 3 – ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)

Here's a breakdown of the acceptance criteria and study information for the Dukal Surgical Mask, based on the provided 510(k) summary:

This device is a surgical mask, and the study described is a performance characteristic comparison against a predicate device and recognized standards, rather than a clinical study involving human readers or AI. Therefore, several sections of your request (MRMC study, standalone performance, training set details) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance of the predicate device and the specified ASTM standards. The reported device performance is compared directly to these.

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

• Sample Size for Test Set:
  • For the Fluid Resistance Performance test (ASTM F1862-05), the sample size was 32 units tested for both the predicate device and the Dukal mask.
  • For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, a specific sample size is not explicitly stated in the provided text, but it is implied that sufficient samples were tested to obtain the reported percentages and average values according to the specified ASTM standards.
• Data Provenance: Not specified, but implied to be from laboratory testing conducted by Dukal Corporation for their device and likely from the predicate device's 510(k) submission for its data. This is a retrospective comparison against listed predicate device performance and standards. The country of origin of the testing is not mentioned.

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

Not applicable. This study involves objective performance testing of a physical product (surgical mask) against defined material specifications and ASTM standards, not the interpretation of medical data by experts. The "ground truth" for each parameter is established by the results of the standardized test methods.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this involves objective physical testing, not expert interpretation requiring adjudication.

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 is not an AI/software device and no MRMC study was performed.

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

Not applicable. This is not an AI/software device. The device's performance is standalone in the sense that its physical properties are measured directly.

7. The Type of Ground Truth Used

The ground truth for the performance characteristics is established by:

• Recognized Performance Standards: Specifically, ASTM F1862-05, ASTM2299, ASTM F2101-01, ASTM F2100-04, and MIL-M-36945C. These standards define the acceptable methodology and often performance benchmarks.
• Predicate Device Performance: The performance data of the legally marketed predicate device (A.R. Medicom K051291) serves as a benchmark for substantial equivalence.
• Raw Material Specifications: For the composition of the mask layers, ear loops, nose piece, and plastic shield.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set was used.

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