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The Disposable Face Mask is 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 proposed device, Disposable Face Mask is a three-layer, single-use, flat-pleated mask. The ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. The disposable surgical mask is available in four different specifications: 14.5cmx9.5cm and 17.5cmx9.5cm. The device is single use and provided non-sterile.

The provided text describes the 510(k) submission for a Disposable Face Mask (K202905) and its equivalence to a predicate device (K160269). However, it does not contain information related to an AI/ML-enabled medical device or a clinical study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI device. The document is strictly about the non-clinical testing and comparison of a traditional medical device (face mask) to a predicate device to demonstrate substantial equivalence.

The document covers:

• Device: Disposable Face Mask
• Purpose: To protect against transfer of microorganisms, body fluids, and particulate material.
• Regulatory Class: Class II, Product Code FXX.
• Acceptance Criteria/Performance (based on standards for face masks):
  • Fluid Resistance (ASTM F1862)
  • Particulate Filtration Efficiency (ASTM F2299)
  • Bacterial Filtration Efficiency (ASTM F2101)
  • Differential Pressure (EN 14683)
  • Flammability (16 CFR 1610)
  • Biocompatibility (ISO 10993-5 and ISO 10993-10)

Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI/ML specifics:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 'acceptance criteria' are implicitly derived from the performance of the predicate device and the relevant ASTM/EN standards for medical face masks. The proposed device had to meet or exceed these to demonstrate substantial equivalence.

Regarding AI/ML specific information (which is not in the document):

2. Sample size used for the test set and data provenance: Not applicable to this device type or study.
3. Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for a face mask's performance is established through standardized laboratory testing (e.g., measuring filtration efficiency, fluid resistance) against predefined physical criteria, not expert interpretation of AI outputs.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No, this was not done as it's not an AI-enabled device requiring human-in-the-loop assessment.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth: (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on physical and biological laboratory measurements according to established international standards (ASTM, EN, ISO).
8. Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a disposable face mask, focusing on non-clinical performance testing against established standards and comparison to a predicate device, not on the performance of an AI/ML system.

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