(279 days)
Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules. Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application.
The provided text describes the performance and equivalency of the device "Riva Star" to predicate devices, primarily "Advantage Arrest" and "Super Seal," for the treatment of dentinal hypersensitivity. However, the text does not contain a formal table of "acceptance criteria" and subsequent "reported device performance" against those criteria in a structured format. Instead, it discusses comparability to predicate devices and results from various tests, which indirectly serve as evidence of the device's acceptable performance.
Based on the information provided, here's a structured response outlining the key aspects:
1. Table of Acceptance Criteria and Reported Device Performance
As there is no explicit table of quantitative acceptance criteria provided in the text, I will infer what appears to be the implicit acceptance criteria from the non-clinical and clinical performance testing sections and present the reported performance of Riva Star against those objectives. The primary objective is substantial equivalence to predicate devices.
| Implicit Acceptance Criterion | Reported Riva Star Performance |
|---|---|
| I. Substantial Equivalence to Predicate Devices | |
| 1. Similar Indications for Use | Met: Indications for Use are identical to primary predicate device Advantage Arrest ("Treatment of dentinal hypersensitivity. For use in adults over the age of 21."). Differences in phrasing with reference predicates do not change the overall intended purpose. |
| 2. Similar Technological Characteristics/Mode of Action | Met: Both Riva Star and primary predicate Advantage Arrest employ silver diamine fluoride to form precipitates and occlude open dentinal tubules. While Riva Star uses potassium iodide for an immediate silver iodide precipitate, and Advantage Arrest reacts with hydroxyapatite, both achieve tubule occlusion. This is considered substantially equivalent. The mode of action (tubule occlusion) is also similar to the oxalate-based reference predicates. |
| 3. Effective Reduction of Fluid Flow through Dentin (Hydraulic Conductance) | Met: Hydraulic Conductance study demonstrated Riva Star is an effective agent to reduce fluid flow through dentine and is "substantially equivalent to Super Seal in treating dentinal hypersensitivity." |
| 4. Formation of Precipitate to Occlude Dentinal Tubules (SEM) | Met: Scanning electron microscope (SEM) images showed both Riva Star and Super Seal formed a precipitate to occlude the open dentinal tubules. |
| 5. Safety (Biocompatibility/Ion Release) | Met: |
- Ion Release: Riva Star released less fluoride and silver ions compared to primary predicate Advantage Arrest in a 7-day in vitro study, "demonstrating that Riva Star is as safe as Advantage Arrest."
- Biocompatibility: Passed Cytotoxicity (ISO Agarose, ISO Direct contact), Sensitisation (ISO Guinea Pig Maximization Sensitization), Oral Mucosal Irritation (Hamsters, collar method, 7 day), and Oral Acute Toxicity (Mice - 7 day) tests, providing "evidence of biocompatibility." Cytotoxicity results were "equivalent" to Advantage Arrest. |
| 6. Shelf Life | Met: Stability testing established a shelf life of "25 months when stored between 2ºC (35ºF) to 8ºC (45ºF)." |
| 7. Clinical Effectiveness in Reducing Dentinal Hypersensitivity | Met: A double-blind randomized clinical trial showed that "Riva Star was more effective than Super Seal in reducing dentine hypersensitivity after 7 days." This demonstrates clinical effectiveness, furthering the case for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Hydraulic Conductance Study: Not explicitly stated how many dentin samples were used.
- Non-Clinical In Vitro Ion Release Study: Not explicitly stated how many samples of Riva Star and Advantage Arrest were tested.
- Biocompatibility Studies (Animals):
- Sensitization: Guinea Pigs (sample size not specified)
- Oral Mucosal Irritation: Hamsters (sample size not specified)
- Oral Acute Toxicity: Mice (sample size not specified)
- Clinical Performance Testing:
- Sample Size: Patients with "recognisable tooth sensitivity on both sides of their upper arch" (Exact number of patients/teeth not specified, but implied to be sufficient for a randomized clinical trial).
- Data Provenance: The study was a "double blind randomised clinical trial on patients." The country of origin is not explicitly stated in the provided text.
- Retrospective or Prospective: Prospective (clinical trial).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Clinical Performance Testing: Ground truth (reduction in dentinal hypersensitivity) was established by patient responses recorded on a Visual Analogue Scale (VAS). This indicates self-reported patient pain levels, not expert consensus as the primary ground truth.
- Non-Clinical Studies: Ground truth for hydraulic conductance, SEM imaging, ion release, and biocompatibility was established through objective laboratory measurements and biological assays, not expert consensus on images or interpretations.
4. Adjudication Method for the Test Set
- Clinical Performance Testing: The primary "ground truth" was patient-reported pain levels via Visual Analogue Scale (VAS). This is a self-adjudication method. The trial was "double blind randomized," suggesting measures were taken to prevent bias in data collection and interpretation. No external expert adjudication method (e.g., 2+1, 3+1) is mentioned for the clinical trial.
- Non-Clinical Studies: No adjudication method as these involved objective laboratory measurements.
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, an MRMC comparative effectiveness study involving human readers or AI assistance was not mentioned. The device, Riva Star, is a dental product (tooth desensitizer), not an imaging or diagnostic AI-powered device that would typically undergo such a study design.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. Riva Star is a physical product (liquid solution) applied by a clinician, not an algorithm.
7. The Type of Ground Truth Used
- Non-Clinical Studies (Hydraulic Conductance, SEM, Ion Release, Stability): Objective laboratory measurements and observations (e.g., fluid flow rate, microscopic images showing precipitate formation, ion concentrations, physical property measurements).
- Biocompatibility Studies: Biological assay results (e.g., cell viability, observed irritation/sensitization responses in animal models).
- Clinical Performance Testing: Patient-reported outcomes (self-reported pain levels) using a Visual Analogue Scale (VAS).
8. The Sample Size for the Training Set
- Not applicable. Riva Star is a physical medical device, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this device.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.