(99 days)
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)
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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. -
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. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the text. -
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. -
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. -
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. -
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. -
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.
§ 874.3900 Nasal dilator.
(a)
Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.