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Our devices are indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.

The Respire Pink AT (Hard, Hard/Soft, EF) is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Pink AT (Hard, Hard/Soft, EF) is made out of dental industry standard acrylic resins & metals, and is custom designed to comfortably fit each patients' unique oral anatomy.

The provided FDA 510(k) summary for the “Respire Pink AT (Hard, Hard/Soft, EF)” device focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report for the device's performance against specific clinical or technical metrics for disease treatment. This summary primarily relies on bench testing and a comparison to its predicate device to show safety and effectiveness.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, or results from MRMC or standalone studies, are not available in the provided text. The device is an oral appliance for treating Obstructive Sleep Apnea (OSA), not a diagnostic tool where "acceptance criteria and reported device performance" as typically understood in AI/imaging devices would apply.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance in treating OSA (e.g., AHI reduction, oxygen saturation). Instead, it relies on demonstrating substantial equivalence to a predicate device and successful completion of non-clinical tests.

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

• Sample size for test set: Not applicable/not provided. The "testing" mentioned is non-clinical bench testing.
• Data provenance: Not applicable. The testing is laboratory-based, not patient data.

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

• Not applicable/not provided. Ground truth in the context of diagnostic performance (e.g., expert consensus on images) is not relevant to this type of device and testing. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

4. Adjudication method for the test set:

• Not applicable/not provided. Adjudication typically applies to multi-reader studies for diagnostic devices.

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-assisted diagnostic 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 a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests (mechanical, biocompatibility, shipping validation), the "ground truth" implicitly refers to established engineering standards, material safety specifications (e.g., ISO 10993), and regulatory requirements for medical devices. The device was assessed against these benchmarks.

8. The sample size for the training set:

• Not applicable. This is not an AI device that uses a training set of data.

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

• Not applicable.

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