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The Respire Blue Scries - EF is indicated to treat mild to moderate OSA (Obstructive Sleep Apnea)

The Respire Blue Series – EF (Endurance Frameworks) – is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates / trays) and chrome - Wironit material (upper / Palatal and lower / Lingual plates / trays). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which are used to hold elastic bands which guide the jaw to the desired position. In addition there are expansion screws inside the Acrylic side plates / trays that allows for device expansion based on patient needs.

The upper and lower components are connected by an adjustable hinge, thus the patient can open and close the mouth while wearing the appliances

The provided text describes the Respire Blue Series - EF intraoral device, indicated for treating mild to moderate Obstructive Sleep Apnea (OSA). The 510(k) submission (K152292) is for a modification to a previously cleared device (K111207), specifically the material used for the top and bottom plates/trays.

Based on the provided text, the acceptance criteria and study information can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: For the Material Integrity testing, five (5) sample devices were used.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It is assumed to be part of the manufacturer's internal testing as described in the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document does not mention the use of experts to establish ground truth for the non-clinical tests described. The tests appear to be laboratory-based material science tests.

4. Adjudication Method for the Test Set

• This information is not applicable as the described tests are laboratory-based material science tests, not clinical studies involving interpretation by multiple experts.

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 MRMC comparative effectiveness study was done. This device is a physical intraoral device, not an AI-assisted diagnostic tool.

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

• No standalone algorithm performance study was done. This device is a physical intraoral device.

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

• For biocompatibility and cytotoxicity, the "ground truth" is defined by the ISO 10993 standards and the specific reactivity thresholds of the MEM Elution test.
• For material integrity, the "ground truth" is established by the mechanical properties (elongation, load-bearing force) of the material compared to a benchmark (the predicate device and the force exerted by a human bite).

8. The sample size for the training set

• A "training set" is not applicable for the type of non-clinical tests described for this physical device. These are material characterization and performance validation tests, not machine learning model training.

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

• This information is not applicable as there is no training set for a machine learning model.

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The Respire Blue Series is indicated to treat mild to moderate OSA. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (OSA).

Respire Blue Series is a patented, custom made device for each patient which consists of two dental plates, upper and lower, made of Acrylic. The attachment is at a 65 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front to add comfort by allowing the patient to inhale and exhale more air per breath. Respire Blue Series are offered in two options: (1) Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface (2) Hard devices which are all acrylic and retained with ball clasps, this allows the device to be tightened if it becomes loose.

The provided document is a 510(k) premarket notification for the Respire Blue Series device, an intraoral device for snoring and obstructive sleep apnea (OSA). The document focuses on demonstrating substantial equivalence to already marketed predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance studies is not explicitly available in the provided text in the typical format of a clinical trial or performance study report.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that if the predicate devices were accepted based on certain performance, and the new device is sufficiently similar and raises no new safety or effectiveness concerns, it can also be accepted.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and their corresponding reported device performance metrics (e.g., sensitivity, specificity, accuracy, AHI reduction percentage) are not defined or explicitly presented in the document for the Respire Blue Series itself.

Instead, the acceptance for market clearance is based on demonstrating substantial equivalence to predicate devices in terms of:

The document states: "Bench testing results have demonstrated that all test method acceptance criteria were met and demonstrated equivalent results to the predicated devices." This implies that physical and mechanical properties were tested against benchmarks established by the predicate devices, but the specific numerical acceptance criteria and results are not provided.

2. Sample Size Used for the Test Set and Data Provenance

Not explicitly provided. The document refers to "Clinical evaluation and observation results" demonstrating the success rate, but it does not specify the sample size, data provenance (e.g., country of origin), or whether the data was retrospective or prospective for the Respire Blue Series. This information would typically be detailed in a separate clinical study report, which is not part of this 510(k) summary. Given the emphasis on substantial equivalence, a full-scale clinical trial might not have been required if adequate existing data supported the predicate devices and the new device's similarity.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/not provided. Since a specific "test set" with ground truth established by experts is not detailed for the Respire Blue Series itself in this document, this information is not available. The "clinical evaluation and observation results" mentioned are not described in enough detail to ascertain how ground truth was established by experts.

4. Adjudication Method for the Test Set

Not applicable/not provided. As there is no detailed description of a test set and associated ground truth establishment, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's functional equivalence and safety, not on human reader performance with or without AI assistance. This device is a physical intraoral appliance, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Respire Blue Series is a physical medical device (an intraoral appliance), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the Respire Blue Series itself, the document states "clinical evaluation and observation results have demonstrated the success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms."

Therefore, for the "clinical evaluation" mentioned, the ground truth for "reduction of apneic events" would have been established by polysomnography (PSG), which is the gold standard for diagnosing sleep apnea.

8. The Sample Size for the Training Set

Not applicable/not provided. As this is a physical medical device and not an AI/ML algorithm requiring a "training set," this information is not relevant or provided.

9. How the Ground Truth for the Training Set Was Established

Not applicable/not provided. This question pertains to AI/ML models, which is not the nature of the Respire Blue Series device.

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