(119 days)
The Rest Assured Ready to Wear Nite 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 Ready to Wear Nite Protector is a posterior-occlusive nightguard, comprised of two molar bite pads connected by a buccal retaining strap. The device is fit to the user's mouth by adjusting the bite plates along the retaining strap.
Here's a breakdown of the acceptance criteria and study information for the Ranir, LLC's Rest Assured Ready to Wear Nite Protector, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 7405) | Met. "ISO 7405 was adhered to in the evaluation of biocompatibility of device materials." No specific performance metrics are given, but compliance with the standard implies acceptable biocompatibility. |
| Wear Resistance (Alabama-type wear testing) | "Wear resistance of the evaluated night guard material was comparable to the tested predicate devices with no abnormal evaluations." |
| Comparability to Predicate Device (with similar design) | "The third party laboratory verified that the subject device is comparable to the predicate device and can be used on the mandibular or maxillary teeth with the adjustable bite plates similar to the predicate device design." |
| Effectiveness of Labeling for Device Use | Met. "Greater than 80% of the tested subjects agreed that the adjustable bite pads were acceptable and 95% of the subjects approved of the overall fitting process and fit their device correctly." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 20 subjects were used for the user study.
- Data Provenance: The document does not specify the country of origin. It is a prospective user study conducted to verify labeling effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no external experts used to establish ground truth in the user study. The "ground truth" for the user study was based on the subjects' own successful fitting of the device and their agreement/approval of the product features and fitting process.
4. Adjudication Method for the Test Set
No formal adjudication method (like 2+1, 3+1) was used as the "ground truth" was derived directly from the subjects' experience and their self-assessment of successful fitting and satisfaction with the bite pads and fitting process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies described are bench tests and a user study focusing on device fit and labeling comprehension.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable. The device is a physical night guard, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.
7. The Type of Ground Truth Used
- Biocompatibility: Compliance with ISO 7405 (a standard).
- Wear Resistance: Comparison to predicate devices, presumably against established wear characteristics of those devices.
- Comparability: Verification by a third-party lab against a predicate device with similar design.
- User Study: Subjective user feedback on acceptability of adjustable bite pads and approval of the overall fitting process/correct fit.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical night guard, and there is no mention of machine learning or an "algorithm" requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an algorithm mentioned.
N/A