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510(k) Data Aggregation
(402 days)
The TheraSom-CAST is used to reduce or alleviate the occurrence of snoring and/or for the treatment of mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.
The TheraSom-CASTTM anti-snoring device is a removable, adjustable intraoral device intended for the treatment of snoring and mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years or older. The device functions as a mandibular repositioner, which acts to improve the patient's ability to breathe without obstruction of the pharyngeal airway. The TheraSom-CAST is customized by molding to conform to the patient's dentition. Like the predicate devices, this device is comprised of an upper and lower component, each fitted over the corresponding dentition and coupled together by a locking mechanism. The locking mechanism of the TheraSom-CAST is formed by stainless steel tension springs connected to the upper and lower components externally on either side of the device. The springs may vary in lengths and may be moved to adjust the relative positions of the upper and lower components so as to set the distance of the mandibular advancement. While the device includes no plastic parts (the upper and lower components are made from dental cast alloy and the springs are formed of stainless steel); this difference in materials and the construction by customized dental cast molding do not introduce any new safety issues.
The provided text describes a 510(k) submission for the TheraSom-CAST™ device, which is an intraoral device intended to treat snoring and mild to moderate obstructive sleep apnea (OSA). The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a formal statistically powered study.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria or provide a table of performance metrics to be compared against such criteria. Instead, it relies on a "feasibility study" and a comparison of substantial equivalence characteristics to predicate devices.
The "feasibility study" reports the following:
| Performance Metric | Reported Device Performance (TheraSom-CAST™) |
|---|---|
| AHI post-treatment | Measured for each patient (specific values not provided, only "measured") |
| Snoring | Patients reported that use of the device at night reduced the symptom of snoring. |
| Gingival Health | Visual screening performed after 8+ months of use (results not explicitly stated, implied to be acceptable as no adverse events mentioned). |
| Tooth Mobility | Physical assessment performed after 8+ months of use (results not explicitly stated, implied to be acceptable as no adverse events mentioned). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Five (5) participants.
- Data Provenance: The study was a "feasibility study." The location is not explicitly stated, but the submitter is Family Dental Services, P.C. in Albuquerque, New Mexico, USA, so it's likely US-based. The study is prospective for the duration of the feasibility assessment, as participants were "assessed with polysomnographic study...with and without the device in place" and followed for "at least 8 months" after use of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish a ground truth for the test set.
- Polysomnographic studies are typically interpreted by sleep physicians or trained sleep technologists.
- Visual screening of gingival health and physical assessment of tooth mobility would typically be performed by a dentist or periodontist.
However, the specific number and qualifications of individuals performing these assessments are not detailed in the summary.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set data. Given the small "feasibility study" size and its nature as a preliminary assessment, a formal adjudication process is unlikely to have been detailed or performed as part of this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission presents a small feasibility study and a substantial equivalence comparison to predicate devices, not a study comparing human readers with and without AI assistance, or comparing human readers generally.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The TheraSom-CAST™ is a physical intraoral device, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not relevant.
7. Type of Ground Truth Used
The ground truth for the feasibility study appears to be a combination of:
- Objective physiological measures: AHI post-treatment from polysomnographic study.
- Expert clinical assessment: Visual screening of gingival health and physical assessment of tooth mobility.
- Patient-reported outcomes: Patients reported reduced snoring.
8. Sample Size for the Training Set
Not applicable. The TheraSom-CAST™ is a physical medical device, not an AI/ML algorithm that requires a training set. The device is customized to each patient through molding and adjustment by a dentist or physician.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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