(42 days)
The Rest Assured® Extra Comfort Nite Protector is indicated for use for protection against bruxism or night time 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 Extra Comfort Nite Protector is indicated 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 teeth grinding.
The Rest Assured® Extra Comfort Nite Guard is an occlusive nightguard. fitted to the consumer by the "boil and bite" method.
Here's an analysis of the acceptance criteria and study information for the Ranir, LLC's Rest Assured® Extra Comfort Nite Protector based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 14971:2007 (Risk Management) | Complies |
| ISO 7405:2008 (Biocompatibility) | Complies, deemed appropriate for intended use and duration of exposure. No safety risk from leachables/extractables. | |
| ISO 10993-1:2009 (Evaluation & Testing) | Complies | |
| ISO 10993-3:2003 (Genotoxicity, Carcinogenicity, Reproductive Toxicity) | Complies | |
| ISO 10993-5:2009 (In vitro Cytotoxicity) | Complies | |
| ISO 10993-10:2010 (Irritation & Skin Sensitization) | Complies | |
| ISO 10993-11:2010 (Systemic Toxicity) | Complies | |
| ISO 10993-17:2002 (Leachable Limits) | Complies | |
| Cytotoxicity | Passed | |
| Oral Mucosal Irritation | Passed | |
| Acute Systemic Toxicity | Passed | |
| Sensitization | Passed | |
| Material Mediated Pyrogenicity | Passed | |
| Leachables/Extractables Characterization | Passed | |
| Genotoxicity | Passed | |
| Physical Characteristics | Comparison to predicate device ("Doctor's Advance Comfort Night Guard") | Found to be comparable |
| Workmanship | Found to be comparable | |
| Performance | Comparison to predicate device | Found to be comparable |
| Simulated Wear Testing | Confirmed modifications do not impact structural integrity. | |
| Boil and Bite Testing | Confirmed modifications do not impact structural integrity. | |
| Hazards | Comparison to predicate device | Found to be comparable |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for the various tests (e.g., number of devices tested for biocompatibility, simulated wear, or boil and bite testing).
Regarding data provenance, the testing was conducted by:
- North American Science Associates, Inc. ("NAMSA") for comprehensive biocompatibility testing.
- A "third party testing" firm for evaluation of physical characteristics, workmanship, performance, and hazards against a predicate device.
The country of origin for the data is not specified beyond "North American Science Associates, Inc." or "third party testing," though the submitter (Ranir, LLC) is based in the U.S. and the submission is to the FDA. The studies appear to be prospective as they were conducted specifically for this device modification and submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a physical dental protector, and the performance testing focuses on material properties, physical characteristics, and simulated use rather than diagnostic accuracy or human interpretation. Therefore, there's no "ground truth" derived from experts in the same way there would be for an AI-powered diagnostic device analyzing medical images. The "ground truth" here is established by the results of standardized tests and evaluations against predicate devices.
4. Adjudication Method for the Test Set
This is not applicable. As explained above, the tests are objective measurements and comparisons, not subjective interpretations requiring adjudication.
5. 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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. The Rest Assured® Extra Comfort Nite Protector is a physical dental device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm-only performance study was not conducted. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing in this submission is established through:
- Compliance with recognized consensus standards (ISO standards) for biocompatibility and risk management.
- Objective laboratory testing results for cytotoxicity, irritation, toxicity, sensitization, pyrogenicity, and leachables/extractables.
- Direct comparison to a legally marketed predicate device ("Doctor's Advance Comfort Night Guard") for physical characteristics, workmanship, performance, and hazards.
- Simulated wear and boil-and-bite testing to confirm structural integrity after modifications.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a physical device submission, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set.
N/A