(225 days)
The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays.
The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.
The Perio Protect Tray is a custom fit tray made from impressions of the patents mouth taken by a licensed dentist. The patient impressions are then sent to a specialized dental laboratory which makes a custom fit tray for the individual patient.
The provided text describes basic performance testing for the Perio Protect Tray, but it does not detail a device that uses AI or advanced analytical methods for diagnosis or decision-making. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert consensus, and comparative effectiveness studies are not applicable to this device.
The "Perio Protect Tray" is a custom-fit dental tray for delivering solutions to gingival crevices. The testing described is functional and safety-related for a physical device, not related to an algorithm's performance.
Here's the information that can be extracted from the provided text:
Acceptance Criteria and Device Performance for Perio Protect Tray
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Solution Delivery | Demonstrate delivery of solutions to teeth and surrounding tissues, specifically gingival sulcus. | - Method: Sodium Fluorescein dye (mixed with aqueous solution and Peroxyl gel) was applied to the tray. |
- Procedure: Patients wore trays for 10-15 minutes (morning and evening for one day).
- Observation: After 24 hours, black light illumination showed Sodium fluorescein dye was observed in the gingival sulcus. This indicates successful delivery of the solution to the targeted area. |
| Tray Retention Force | Demonstrate the force necessary to remove the tray. | - Method: A gram gauge was used to remove the tray from the patient's mouth. - Procedure: Each test was repeated 10 times.
- Result: An average of the force necessary to remove the tray was computed. (Specific numerical value for the average force is not provided in the summary, only that it was computed). |
Study Details (Based on available information)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of patients for either test (solution delivery or retention force). The text uses "The patients wore the trays" and "Trays were also placed in the patient's mouth," suggesting more than one patient, but no specific count.
- Data Provenance: Not specified (e.g., country of origin). The study appears to be proprietary testing conducted by the manufacturer or a contracted entity for regulatory submission. It is a prospective test as it describes an experiment being conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical dental tray, and the "ground truth" for its performance is directly observable physical phenomena (presence of dye, measured force). There is no "ground truth" established by experts in the context of interpretation or diagnosis as would be relevant for an AI system. The "clinician" determines the choice of solution and usage parameters.
4. Adjudication method for the test set:
- None. Adjudication methods (like 2+1, 3+1) are typically used when subjective interpretations or discrepancies in expert opinions need to be resolved, usually for AI-driven diagnostic or screening devices. For the physical tests described, observations (presence of dye) and measurements (force) are direct.
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. This device is not an AI system or an interpretative tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical product, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The type of ground truth used:
- For Solution Delivery: The "ground truth" was direct observation of a physical phenomenon – the presence of phosphorescent Sodium Fluorescein dye in the gingival sulcus under a black light.
- For Tray Retention Force: The "ground truth" was direct measurement using a gram gauge.
8. The sample size for the training set:
- Not Applicable. This device does not involve machine learning or AI, so there is no training set in the computational sense. The "custom fit tray" process involves taking impressions of individual patients as part of its manufacturing, but this is not a "training set" for an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for an algorithm.
§ 872.6870 Disposable fluoride tray.
(a)
Identification. A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically to the teeth. To use the tray, the patient bites down on the tray which has been filled with a fluoride solution.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.