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The InVent Snoring Device is intended to reduce or eliminate snoring.

As with the predicate device, the subject device is a nasal dilator intended to reduce or eliminate snoring. While the predicate device is an internal nasal dilator, the subject device is an external nasal dilator in which the device is placed over the patient's nostrils. As with the predicate device, the subject device creates dilating pressure or expiratory positive airway pressure (EPAP) to dilate and open the nasal airway. The device directs expiratory flow though selected pathways, which maintain nasal airway pressure and help maintain nasal passage dilation.

The provided text does not contain detailed acceptance criteria or a comprehensive study description with all the requested information categories. However, based on the available text, here's an attempt to answer your questions as much as possible:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states that "Bench testing of the subject device confirms that it meets pre-defined specifications" and "Clinical testing also supports that the device is safe and effective for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed performance metrics. The primary claim for regulatory approval is substantial equivalence to a predicate device, not necessarily meeting a specific set of performance thresholds outlined in a table.

Therefore, a table of acceptance criteria and reported device performance cannot be generated with the given information as the specific criteria and corresponding performance values are not disclosed. The device is intended to "reduce or eliminate snoring."

Study Information (Based on available text)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The text states "Clinical testing also supports that the device is safe and effective for its intended use." However, it does not provide any details about the sample size, the country of origin of the data, or whether the study was retrospective or prospective.

2. 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):
   This information is not provided in the text.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not provided in the text.

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:
   This is not an AI device. The InVent Snoring Device is a physical nasal dilator. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This is not an AI device. Therefore, a standalone algorithm performance study is not applicable and was not performed.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Given the device's function (reducing snoring), the "ground truth" for effectiveness in a clinical study would likely involve objective measurements of snoring (e.g., sound intensity, apnea-hypopnea index if linked to sleep-disordered breathing) or subjective patient/partner reports of snoring reduction. However, the text does not specify the type of ground truth used in their clinical testing.

7. The sample size for the training set:
   This is not an AI/algorithm-based device, so the concept of a "training set" in the context of machine learning is not applicable here.

8. How the ground truth for the training set was established:
   As above, the concept of a "training set" and its ground truth is not applicable for this physical device.

Summary of what can be gleaned from the text:

• Device Type: Nasal dilator for snoring.
• Approval Basis: Substantial equivalence to a predicate device (BR2 Nasal Dilator).
• Performance Evidence:
  • Bench testing confirmed conformity to "pre-defined specifications" (details not provided).
  • Clinical testing supported "safety and effectiveness for its intended use" (details not provided).
• Missing Information: Specific acceptance criteria, detailed performance metrics, sample sizes for any studies, data provenance, expert qualifications, ground truth establishment methods, and any AI/algorithm-related study details are absent because the device is not an AI product.

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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 Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent™ Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.

The Provent Nasal Cannula was developed to transmit pressure signals from the Provent Professional Sleep Apnea Therapy device to a pressure transducer of a physiologic recorder during sleep evaluations. The Provent Nasal Cannula is specifically designed to attach the Provent Professional Sleep Apnea Therapy (Provent PSAT, K071560) device to standard pressure transducers.

The Provent Nasal Cannula is essentially identical to standard nasal cannulae except for its custom connection to the Provent PSAT. The Provent Nasal Cannula is comprised of the same design elements as a standard nasal cannula:

1. a bifurcated tube with a luer lock connector,
2. an anti-microbial filter at one end, and
3. a component to hold the tubes in the correct location near the nostrils at the other end.

The Provent nasal cannula is worn in the same way as the standard nasal cannulae, with the proximal ends held in place in the path of nasal airflow and the tubing routed over the ears and under the chin.

The document describes the Provent Nasal Cannula, indicated for transmitting respiratory airflow signals during sleep studies, specifically with the Provent Professional Sleep Apnea Therapy device. The submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "Performance Data" section briefly states that "Bench data were submitted to support the 510(k) Notification. The bench testing demonstrated that the device is safe and effective for its intended use." However, it does not elaborate on specific quantitative acceptance criteria or results.

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

The document mentions "bench testing" but does not specify a "test set" in the context of human subjects or clinical data. There is no information regarding sample size, data provenance (e.g., country of origin, retrospective or prospective), as the testing appears to be primarily laboratory-based to confirm basic functionality and safety.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the submission does not detail a clinical study involving human interpretation or ground truth establishment by experts. The focus is on the device's physical and functional equivalence to existing devices for signal transmission.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a human-reviewed test set requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done, nor is it relevant given the nature of the device (a nasal cannula for signal transmission). The study does not involve human interpretation with or without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a physical medical device (nasal cannula), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable. The "performance data" refers to bench testing of the physical properties and function of the cannula.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) is not applicable in the context presented. The "ground truth" for the bench testing would be predefined engineering specifications or performance standards for pressure signal transmission, rather than clinical ground truth established by experts.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model, so there is no training set.

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

Not applicable. As there is no training set for an AI/ML model, the establishment of ground truth for it is irrelevant.

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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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