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Bongo is indicated for use in the treatment of mild to moderate obstructive sleep apnea (OSA) in adults >66 lbs.

The Bongo intranasal appliance is a simple device which is placed just inside the nostrils. The device directs expiratory flow through small vent ports which increases intranasal pressure similar to the expiratory portion of the breathing cycle during use of the predicate device. The Bongo consists of valve assemblies coupled with nasal inserts. The Bongo has soft nasal inserts to form a seal within the nasal openings. The nasal inserts are offered in various sizes.

The Bongo intranasal appliance is intended for the treatment of mild to moderate obstructive sleep apnea (OSA) in adults weighing over 66 lbs.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a formal "acceptance criteria" table with specific pass/fail thresholds for clinical performance. However, it does describe the performance observed in the clinical study and compares it to the predicate device. Based on the "Clinical Testing" section, the implicit clinical acceptance criterion is a reduction in AHI.

2. Sample Size and Data Provenance

• Test Set Sample Size: N=10 patients who completed the clinical study.
• Data Provenance: The document states "A prospective, non-randomized, open label, single-center clinical study was performed." The country of origin is not explicitly mentioned, but the FDA submission suggests it adheres to US regulatory standards. It is a prospective study.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the "number of experts" or their specific "qualifications" used to establish the ground truth for the clinical study. However, the ground truth (AHI) was likely determined by sleep specialists or trained sleep technologists interpreting Polysomnography (PSG) results, as is standard clinical practice for OSA diagnosis and monitoring.

4. Adjudication Method

The document does not detail any specific adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth of the test set. The clinical study's outcome measures (AHI reduction from PSG) would typically involve interpretation by a single qualified professional per sleep study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The clinical study described is for the device's performance in reducing AHI and does not involve comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

This device is an intranasal appliance, not an AI algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable. The performance described is of the physical device worn by patients.

7. Type of Ground Truth Used

The primary ground truth used for the clinical study was Polysomnography (PSG) data, specifically the Apnea-Hypopnea Index (AHI) measurements. This is a recognized objective measure for the diagnosis and severity of obstructive sleep apnea.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. The clinical study described involves patients testing the physical device, not an algorithm being trained.

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

As there is no mention of an algorithm training set, this question is not applicable. The clinical study's ground truth for the "test set" (N=10 patients) was established through PSG recordings.

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