Search Results
Found 2 results
510(k) Data Aggregation
(22 days)
The Rest Assured Generation III Dental Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
The Rest Assured III is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method. The Rest Assured III is the same device as Ranir's Rest Assured Generation II with the following minor differences: a reduction in the overall mass of the device, slight increase in arc width, additional impression material and base material, removal of sidewall material, addition of a small triangle fitting notch, and limited labeling changes.
The provided text describes a 510(k) summary for the Ranir, LLC's Rest Assured Generation III Dental Protector. It details the device's purpose, technological characteristics, intended use, and performance testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 14971 Adherence (Risk Analysis) | Risk analysis for the subject device was performed per ISO 14971. |
| ISO 7405 Adherence (Biocompatibility) | ISO 7405 was adhered to in the evaluation of biocompatibility of device materials. |
| Comparability to Legally Marketed Device | A third-party testing laboratory verified that the subject device is comparable to a legally marketed predicate device. |
| Increased Flexibility and Ease in Fitting Process (User Study) | 90% of participants were pleased with the overall fitting process and fit their device correctly. |
2. Sample Size Used for the Test Set and Data Provenance
- User study: The text states "Ninety percent (90%) of the participants." While a percentage is given, the exact number of participants (sample size) in the user study is not specified.
- Data Provenance: The text does not explicitly state the country of origin or if the user study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes a user study for fitting process satisfaction, not a study requiring expert-established ground truth for a diagnostic or evaluative purpose. Therefore, this information is not applicable or not provided in the context of expert ground truth. The "ground truth" for the user study would likely be the self-reported satisfaction and correct fitting as assessed by the users themselves.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method as would be typical for a study involving expert review for accuracy or consensus. The user study evaluated user satisfaction and correct fitting, which is typically a subjective, self-reported assessment by the participants or direct observation by the study administrators rather than an adjudicated expert review. Therefore, an adjudication method is not applicable or not provided for the type of study conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a user study focused on the fitting process and satisfaction with a new device modification, not a comparative effectiveness study involving human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical dental protector, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable. The performance testing focused on material biocompatibility, comparability to predicate devices, and user fitting experience.
7. The Type of Ground Truth Used
- For Biocompatibility and Comparability Testing: The ground truth would be established through laboratory testing standards (ISO 7405) and direct comparison against a legally marketed predicate device using objective physical/material properties.
- For the User Study: The "ground truth" for the user study's success metric (90% pleased with fitting process and fit correctly) would be self-reported satisfaction from the participants and potentially observational assessment by the study administrators regarding correct fitting. It is not expert consensus, pathology, or outcomes data in the usual sense.
8. The Sample Size for the Training Set
This device is a physical dental protector, not a machine learning model. Therefore, there is no training set for an algorithm. The concept of a "training set" is not applicable to this type of device and study.
9. How the Ground Truth for the Training Set Was Established
As there is no training set (see point 8), the ground truth for a training set is not applicable.
Ask a specific question about this device
(3 days)
The Custom Comfort Nightguard Version 2 is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
The Custom Comfort Nightguard Version 2 is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces.
This document is a 510(k) summary for a medical device (Custom Comfort Nightguard Version 2). It indicates that the device has undergone no new clinical studies and instead relies on substantial equivalence to previously cleared predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance criteria and reported device performance (no new performance data presented)
- Sample size for the test set and data provenance
- Number of experts and their qualifications for establishing ground truth
- Adjudication method for the test set
- MRMC comparative effectiveness study results or effect size
- Standalone algorithm performance
- Type of ground truth used (for a new study)
- Sample size for the training set
- How ground truth for the training set was established
Explanation:
The document explicitly states its purpose is a "Special 510(k) notice" for a "modification" to existing devices. It concludes that "The minor modifications made to the device do not raise any new questions of safety or effectiveness. Thus, the Custom Comfort Nightguard Version 2 is substantially equivalent to its predicate devices." This means the FDA did not require new performance data or clinical studies for this submission. The device's safety and effectiveness are assumed based on its similarity to previously cleared devices.
Ask a specific question about this device
Page 1 of 1