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The Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple patient use in a hospital or clinic anway prood after high-level disinfection and for single-patient use in a home environment.

The SOYALA Full Face Mask GEL vented is a molded plastic mask, including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy. It consists of a gel mask cushion, gel forehead cushion, mask frame, coarse adjustment it component, fine adjustment, forehead support, headgear, headgear clip, ports for pressure measurement, port cap, rotating sleeve, elbow, and retaining ring. The mask provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device.

The provided text describes a 510(k) premarket notification for the SOYALA Full Face Mask GEL vented. The submission focuses on demonstrating substantial equivalence to a predicate device through material changes and refers to summary device testing.

However, the document does not contain specific details about acceptance criteria or a comprehensive study report with quantitative performance data that would allow for a detailed table comparing acceptance criteria to reported device performance metrics. It merely states that "All tests were verified to meet acceptance criteria."

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide detailed information on sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone performance) as these are not present in the document.

Here's what can be extracted and inferred from the text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in quantitative terms. The document vaguely mentions "meet acceptance criteria" for biocompatibility and bench testing.
   • Reported Device Performance: Not explicitly stated in quantitative terms. The document states that "Safety and effectiveness are not affected by these changes" and "equivalent performance" in comparison to the predicate device.

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

   • Sample Size (Test Set): Not specified.
   • Data Provenance: Not specified. The document only mentions "Bench testing was performed."

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

   • Not applicable as the testing described is "Biocompatibility testing" and "Bench testing" for a physical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

   • Not applicable for the type of testing described (biocompatibility and bench testing for a physical device).

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. This is irrelevant as the device is a medical mask, not an AI-driven diagnostic or image analysis tool.

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

   • No. This is irrelevant as the device is a medical mask, not an AI or algorithmic system.

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

   • For biocompatibility, the ground truth would be established by validated test methods (e.g., ISO 10993 standards) that determine if materials are cytotoxic, sensitizing, irritating, etc.
   • For bench testing, the ground truth would be the established engineering specifications and performance parameters (e.g., airflow resistance, leak rates, durability) against which the device's performance is measured. The document does not provide details of these specific parameters.

8. The sample size for the training set:

   • Not applicable. 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. This is not an AI/ML device.

Summary based on the provided text:

The submission for the SOYALA Full Face Mask GEL vented is a 510(k) for substantial equivalence. It asserts that the modified device has the "same technological characteristics," "same intended use," "same operating principle," "same fundamental scientific technology," and "same mask design" as the predicate device (SOYALA Full Face Mask, K061653). The changes primarily relate to "Some materials," and the submission states that "Safety and effectiveness are not affected by these changes."

The study that "proves the device meets the acceptance criteria" is described as:

• Biocompatibility testing: Performed to "verify the equivalent safety of the materials that are used."
• Bench testing: Performed to "verify equivalent performance."

The document states, "All tests were verified to meet acceptance criteria," but does not elaborate on what those criteria were or provide quantitative results. It concludes that the device "is substantially equivalent to legally marketed predicate device and is safe and effective for its intended use, and performs as well as the predicate device."

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