Search Results
Found 2 results
510(k) Data Aggregation
(269 days)
DNA Appliance
The DNA Appliance is intended to reduce nighttime snoring and to treat moderate and severe obstructive sleep apnea in children, 6- 17 years of age who are diagnosed with snoring and/or moderate or severe obstructive sleep apnea and need orthodontic treatment.
The DNA appliance is an intraoral device that consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient.
The provided document is a 510(k) summary for the DNA Appliance, intended to reduce snoring and treat obstructive sleep apnea in children. It includes a section on clinical testing which details the study performed to demonstrate the device's efficacy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a structured table format. However, it reports several metrics of improvement. We can infer the "acceptance" was based on these positive outcomes.
| Metric | Reported Device Performance |
|---|---|
| AHI (Apnea-Hypopnea Index) Outcome | 94% of patients had their AHI improve or stay the same. |
| AHI Improvement (50% or more) | 61% of patients improved by 50% or more. |
| AHI Classification Improvement | 57% of patients improved by 1 classification. |
| OSA Resolution | 18% of patients had their OSA resolved. |
| Overall AHI Score Improvement | AHI scores improved by 46%. |
| Improvement in Moderate/Severe AHI | 62.7% improvement in moderate and severe AHI. 96% of moderate/severe patients improved or stayed the same, and 92% improved by >50% or 1 classification (100% of severe patients achieved this). |
| PSQ (Pediatric Sleep Questionnaire) | PSQ scores improved by 50%. 92% of patients improved or had their PSQ score stay the same. |
| SRBD (Sleep-Related Breathing Disorders) | SRBD scores improved by 58%. 92% of patients improved or had their SRBD score stay the same. |
| Airway Volume Increase | Airway volume increased by 40%. |
| Intramolar Width Increase | All patients showed an increase in intramolar width by an average of 13.6%. |
| Safety Issues | No safety issues were observed in children. |
2. Sample Size and Data Provenance
- Sample Size for the Test Set: 48 patients.
- Data Provenance: The study was conducted at 5 sites, specifically "4 U.S. and 1 Canadian." It was a "prospective, clinical trial."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document states: "Patients were diagnosed with obstructive sleep apnea by a medical physician reading a HSAT, a pediatric questionnaire, and needed orthodontic treatment for dentofacial abnormalities." It does not specify the number of medical physicians (experts) or their detailed qualifications (e.g., years of experience, specific board certifications beyond "medical physician").
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth diagnoses. It only mentions that diagnosis was made by a single "medical physician."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the effectiveness of the device and the improvement in patient metrics, rather than comparing AI-assisted human readers to unassisted human readers.
6. Standalone Performance
The study evaluates the device's performance in patients, not the performance of an algorithm as a standalone diagnostic tool. The "performance" metrics (AHI, PSQ, SRBD improvements, etc.) are clinical outcomes after using the physical device. The text states: "All these results are measured during sleep studies without the appliance in the mouth," indicating that the "performance" reflects the long-term changes induced by using the device, not the immediate effect of wearing it or a diagnostic algorithm's output.
7. Type of Ground Truth Used
The ground truth for diagnosis of obstructive sleep apnea was established by:
- "a medical physician reading a HSAT [Home Sleep Apnea Test]"
- "a pediatric questionnaire"
- The need for "orthodontic treatment for dentofacial abnormalities"
Sleep studies (both baseline and post-treatment) were also used to measure outcomes (e.g., AHI scores), which served as objective measures for evaluating the device's effectiveness against the initial ground truth diagnosis.
8. Sample Size for the Training Set
The document describes a clinical trial (the "test set") but does not mention a separate "training set" for an AI or machine learning algorithm. This suggests the device is a physical appliance, not a software algorithm with a distinct training phase.
9. How Ground Truth for the Training Set Was Established
As there is no mention of an AI/ML algorithm or a training set, this question is not applicable based on the provided text. The device is a physical intraoral appliance.
Ask a specific question about this device
(99 days)
DNA Appliance
The DNA Appliance is intended to reduce snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
The DNA appliance is an intraoral device to reduce snoring, and/or mild to moderate sleep apnea in adults 18 years of age and older. It consists of either an upper tray, or both, and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient.
The device is identical to the already-marketed mRNA appliance except the top and bottom trays do not interlock to advance the jaw.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving that the device meets such criteria. The document is a 510(k) premarket notification for the DNA Appliance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (mRNA appliance) rather than presenting performance data against defined acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The document primarily focuses on:
- Device Description: The DNA Appliance's components, mechanism of action, and customization.
- Intended Use: Reducing snoring and/or mild to moderate obstructive sleep apnea in adults 18 years and older.
- Comparison to Predicate Device: Highlighting similarities in mechanism, design (except for mandibular advancement), materials, cleaning instructions, and labeling with the mRNA appliance.
- Testing: Mentioning a risk analysis and reliance on peer-reviewed literature and Real-World Data (RWD) to demonstrate the DNA Appliance's ability to reduce snoring and sleep apnea, asserting no new safety and efficacy questions compared to the predicate device.
To answer your specific questions, I would need a different type of document, such as a clinical study report or a detailed device performance evaluation.
Ask a specific question about this device
Page 1 of 1