Search Results

The Meridian Nasal Mask is intended for Single Patient multi-use by adult patients (>66lb/30Kg) prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospitals, clinics and/or home environments.

The Meridian Mask is a respirator mask covering the nose. It is a patient interface accessory to CPAP and bilevel devices for use in hospitals, clinics and at home.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Meridian Mask:

It's important to note that the provided documents (K050142) primarily describe a 510(k) submission for a medical device that claims substantial equivalence to a predicate device. This type of submission often focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving performance against specific acceptance criteria through a large, independent clinical trial with detailed statistical analysis.

Based on the provided text, the information is limited regarding explicit acceptance criteria and a detailed study report that would typically accompany a more rigorous performance validation.

Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Text)

The document describes a submission for substantial equivalence, which typically relies on demonstrating that the new device is as safe and effective as a predicate device, rather than a standalone clinical study to establish novel performance metrics or acceptance criteria for a new class of device.

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

• Test Set Sample Size: Not explicitly stated. The document refers to "Performance testing" and "materials biocompatibility testing" but does not detail the sample sizes for these tests (e.g., how many masks were tested, how many subjects were involved if human factors testing was performed).
• Data Provenance: Not specified. Given it's a 510(k) for a modified version of an existing product, it's likely internal testing by the manufacturer (ResMed Ltd, Australia). It's generally retrospective data concerning the modifications being evaluated.

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

• This information is not provided. Ground truth establishment as typically understood in clinical or AI studies (e.g., expert consensus for diagnostic accuracy) is not relevant or described for this type of submission which focuses on engineering performance and substantial equivalence.

3. Adjudication method for the test set:

• This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers interpret images or data to establish a definitive ground truth. This submission describes engineering and biocompatibility testing.

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. An MRMC study is not mentioned and is not relevant for this type of device (a nasal mask) or this type of 510(k) submission, which focuses on hardware equivalence and performance rather than AI-assisted interpretation by human readers.

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

• No. This device is a physical nasal mask, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

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

• For the "Performance Data," the "ground truth" would be established by engineering specifications, regulatory standards (e.g., ISO for biocompatibility), and comparison to the predicate device's established performance. For biocompatibility, it's adherence to international standards and material safety data. For functional performance (e.g., seal, pressure delivery), it would be against predefined engineering design requirements.

7. The sample size for the training set:

• This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

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

• This information is not applicable/provided for the same reason as above.

Summary of the Study:

The "study" described in K050142 is not a traditional clinical trial or performance study with detailed acceptance criteria and statistical analysis as one might see for a diagnostic device or a new therapeutic. Instead, it is a substantial equivalence determination process.

The "study" involves:

• Risk Analysis: Identifying potential risks associated with the modifications of the Meridian Mask compared to its predicate.
• Performance Testing: Conducting tests specified by the risk analysis to ensure the device meets its design input requirements for safety and effectiveness. The specific tests are not detailed but would likely include evaluations of:
  • Seal integrity
  • Comfort (potentially subjective user feedback, though not detailed)
  • Durability
  • Compatibility with CPAP/bilevel devices
  • Airflow characteristics
• Materials Biocompatibility Testing: Ensuring that the materials used in the mask are safe for human contact and air path, typically by conforming to ISO 10993 standards and FDA guidance. This often involves laboratory tests on the materials themselves rather than human subjects.
• Comparison to Predicate Device: Demonstrating that the Meridian Mask has the same intended use, similar technological characteristics, and a similar manufacturing process to the Modular Mask (K961783), thereby establishing it is "substantially equivalent" and thus "as safe and as effective" as the predicate.

The document concludes that "The results of the performance data and materials biocompatibility testing show that the mask is substantially equivalent with the unmodified predicate mask." This statement serves as the overall "proof" that the device meets the implicit acceptance criteria of being equivalent to a legally marketed device.

Ask a specific question about this device