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The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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.

The Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. The Surgical Masks will be provided in blue. The medical face masks are sold nonsterile and are intended to be single use, disposable devices. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of polyester. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.

Here's a breakdown of the acceptance criteria and study information for the Surgical Mask, based on the provided document:

Acceptance Criteria and Device Performance

Study Information

The provided document describes non-clinical tests conducted to demonstrate that the proposed device meets its design specifications and acceptance criteria. This is primarily a standalone performance study as it evaluates the device's physical and biological properties.

1. Sample sizes used for the test set and data provenance:

   • Fluid Resistance (ASTM F1862-13): "182 out of 182 pass." This indicates a sample size of 182 masks were tested for fluid resistance.
   • For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, specific sample sizes are not explicitly stated for the "Proposed Device" results, but the footnote mentions "Acceptable sampling plans are found in ISO 2859-1 with an acceptable quality limit of 4 %". This implies that standard sampling methods were followed.
   • Biocompatibility: The results (non-cytotoxic, non-irritating, non-sensitizing) are qualitative statements, and specific numerical sample sizes for these tests are not provided in the summary.
   • Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests, nor does it explicitly state whether the study was retrospective or prospective. Given the nature of performance testing for device submission, it's generally prospective as the tests are conducted specifically for the submission.

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

   • Not applicable. This is a non-clinical, laboratory-based performance study, not a study requiring expert consensus for ground truth on patient outcomes or diagnoses. The "ground truth" is defined by the established ASTM and ISO standards and test methodologies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This type of adjudication is typically used in clinical studies when interpreting ambiguous cases or disagreeing expert opinions. For objective laboratory tests, the results are quantitative or qualitative assessments against defined criteria, not subject to human adjudication in this sense.

4. 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, a MRMC comparative effectiveness study was not done. This device is a surgical mask, and the evaluation focuses on its physical and biological performance characteristics, not on the effectiveness of human readers or AI assistance.

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

   • Yes, a standalone study was done. The non-clinical tests described are evaluations of the device's intrinsic properties and performance, independent of human interaction or interpretation beyond performing the test procedures.

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

   • The ground truth for these non-clinical tests is based on established industry standards and test methodologies (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, MIL-M-36954C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). The performance of the mask is measured against the quantitative and qualitative requirements set forth in these standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set. The "device" in question is a physical product (surgical mask). The tests evaluate its performance characteristics directly.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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