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ULTepap ™ is indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults> 66bs.

The ULTepap™ is a single patient, reusable device intended to treat mild to moderate OSA. It is comprised of a soft silicon rubber body that contains a pair of bi-resistance airflow cartridges, has flanges to attach headgear, and has nasal pillows to interface with the nares. The device is held in place on the patients face by means of a common CPAP mask headgear which is provided in the packaging. The device creates a therapeutic level of positive pressure on exhalation by means of the airflow cartridges that allow air to enter the patient's upper airway without resistance on inhalation and created resistance to airflow on exhalation. The airflow cartridges are comprised of a cylinder and a flexible thin-walled shell which are aligned with the nasal pillows to allow unimpeded inspiration and partially restricted expiration to create the appropriate level of therapeutic back pressure. The thin-walled shells collapse on inspiration and re-inflate on expiration and create a restricted area for expiration by inflating and sealing the inner diameter of the cylinder, forcing expiration through a series of channels molded in the cylinder.

This is a 510(k) summary for a medical device called ULTepap, an intranasal device intended to treat mild to moderate Obstructive Sleep Apnea (OSA) in adults.

Based on the provided information, I can answer your questions:

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

The document does not explicitly state "acceptance criteria" with specific thresholds for performance. Instead, it describes non-clinical tests conducted to demonstrate the device's substantial equivalence to predicate devices. The reported device performance is presented as a comparison to these predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing. It does not provide details on sample sizes for any of the non-clinical tests (e.g., how many devices were subjected to airflow cartridge fatigue or comfort evaluation).

For clinical testing, the document explicitly states: "No clinical testing was performed in association with this submission." Therefore, there is no clinical test set, sample size, or data provenance to report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since "No clinical testing was performed," there was no clinical ground truth established by experts for a test set. The document does not describe the use of experts in establishing ground truth for the non-clinical tests mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as "No clinical testing was performed" and no clinical test set was used to assess the device's performance against a ground truth established by 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

Not applicable. The ULTepap™ is a physical medical device (an intranasal device for OSA treatment) and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

Not applicable. The ULTepap™ is a physical medical device, not an algorithm.

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

For the non-clinical tests, the "ground truth" was based on established engineering and materials science standards (e.g., ISO 10993 for biocompatibility) and comparisons to existing predicate devices (e.g., for back pressure range). Since no clinical trials were conducted, no clinical ground truth (expert consensus, pathology, outcomes data) was used in this submission.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm requiring a training set.

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

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth.

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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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The PROVENT® Sleep Apnea Therapy Device is indicated for use in the treatment of obstructive sleep apnea (OSA).

The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.

The provided text is a 510(k) summary for the PROVENT® Sleep Apnea Therapy device. It contains regulatory information, device description, and indications for use, but it does not contain any performance data, acceptance criteria, or details of a study that proves the device meets specific criteria.

Therefore, I cannot provide the requested information in the format requested. The document explicitly states:

"Non-clinical and clinical testing demonstrated substantial equivalence of the modified devices to the predicate devices when used according to the intended use."

However, it does not present the results of these tests, define "acceptance criteria," or elaborate on the study design (sample size, ground truth, expert qualifications, etc.).

To answer your request, I would need a different document that details the specific performance data and the study conducted to demonstrate that the PROVENT® Sleep Apnea Therapy device meets its acceptance criteria.

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The PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 intended use is for the treatment of obstructive sleep apnea (OSA).

The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.

The provided 510(k) summary for K090398, "PROVENT™ Professional Sleep Apnea Therapy – 50 cm H2O sec/liter", does not contain the detailed information requested regarding acceptance criteria, study design for device performance, or human-in-the-loop studies.

Instead, the summary states:

"Non-clinical and clinical testing demonstrated substantial equivalence of the PROVENT 50 device to the predicate device when used according to its intended use."

This indicates that the submission relied on demonstrating the new device (PROVENT 50) was substantially equivalent to a previously cleared predicate device (Provent™ Professional Sleep Apnea Therapy, K071560), rather than presenting new, detailed performance study data against specific quantitative acceptance criteria or evaluating AI components. Since this device is not an AI/ML powered device, the questions regarding multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for AI models are not applicable.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically provides a high-level overview and does not always include the exhaustive details of performance studies that would be found in the full 510(k) submission.

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The Provent™ Professional Sleep Apnea Therapy device is indicated for use in the treatment of obstructive sleep apnea (OSA).

The Provent device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.

The provided text describes a 510(k) submission for the Provent™ Professional Sleep Apnea Therapy device. While it mentions that "Bench and clinical performance data were submitted to support the 510(k) Notification" and that "The bench and clinical testing demonstrated that the device is safe and effective for its intended use," it does not provide specific acceptance criteria or details of the study that proves the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use, product codes, mechanism of action, and other general characteristics.

Therefore, I cannot populate the requested table and information based on the provided text.

Specifically, the following information is missing from the provided text:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance thresholds are mentioned.
• Sample sized used for the test set and the data provenance: No details on the number of patients/subjects, their demographics, or where the data came from (e.g., country, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of expert involvement or ground truth establishment for a test set.
• Adjudication method: Not applicable as no expert review process is described.
• 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: This device is a therapeutic device, not an AI-powered diagnostic tool, so an MRMC study is not relevant in this context.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical therapeutic device.
• The type of ground truth used: No ground truth is mentioned.
• The sample size for the training set: This refers to a machine learning context, which is not applicable here.
• How the ground truth for the training set was established: Not applicable.

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