(438 days)
Treatment of Dental Hypersensitivity for use in adults over the age of 21.
The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant. The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators and the Instructions for Use (IFU). The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Centrix FluoroSilver Silver Diamine Fluoride 38%). This type of document is provided when a company seeks to demonstrate that their new device is substantially equivalent to a legally marketed predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through various performance and material characteristic comparisons, rather than clinical efficacy trials with predefined clinical acceptance criteria as would be typical for a PMA.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are implicitly defined by the characteristics of the predicate device and relevant standards. The goal is to show the new device is "substantially equivalent."
| Characteristic / Parameter | Implicit "Acceptance Criteria" (Predicate Device Performance/Standard) | Reported Device Performance (Centrix FluoroSilver) | Discussion / Substantial Equivalence |
|---|---|---|---|
| Primary Mode of Action | Reduce dentinal hypersensitivity by occluding open dentin tubules by formation of a precipitate. | Reduce dentinal hypersensitivity by occluding open dentin tubules by formation of a precipitate. | Identical |
| Indications for Use | Treatment of dentinal hypersensitivity for use in adults over the age of 21. | Treatment of Dental Hypersensitivity for use in adults over the age of 21. | Identical |
| SDF Concentration (w/v) | 38.3% to 43.2% (of predicate, based on general description) | 38.3% to 43.2% w/v (stated in device description) | Identical range. The comparison table states 38% for both. |
| Silver Diamine Fluoride (SDF) | 360 - 400 g/L (as per predicate's typical specifications) | 360 - 400 g/L | Specifications match. |
| Fluoride | 50 - 60 g/L | 50 - 60 g/L | Specifications match. |
| pH | 8.5 - 9.5 | 8.5 - 9.5 | Specifications match. |
| Density | 1.265 - 1.276 g/L | 1.265 - 1.276 g/L | Specifications match. |
| Cytotoxicity (ISO 10993-5) | Positive cytotoxicity (predicate device) | "Unsuitable for analysis" due to high precipitate, and performed identically to predicate. | Both devices showed positive cytotoxicity when tested, and their performance was identical ("unsuitable for analysis" due to precipitate formation). This is considered equivalent for the purpose of demonstrating safety profile similarity, given the context of a dentin desensitizer that causes precipitation. |
| Skin Sensitization (ISO 10993-10) | Not considered a contact skin sensitizer (presumably the predicate also meets this) | NOT considered to be a contact skin sensitizer. | Acceptable and considered safe. There is no explicit statement about the predicate's performance on this specific test, but the conclusion for the subject device is a positive safety finding. |
| Irritation (ISO 10993-23) | Non-Irritant to oral mucosa (presumably the predicate also meets this) | Non-Irritant to oral mucosa. | Acceptable and considered safe. Similar to skin sensitization, this is a positive safety finding. |
| Acute Systemic Toxicity (ISO 10993-11) | No signs of gross toxicity, adverse clinical effects, or abnormal behavior (predicate device) | No signs of gross toxicity, adverse clinical effects, or abnormal behavior. No gross abnormalities noted after 3 day observation and necropsy. Performed identically to predicate. | Identical performance with the predicate. Both met requirements. |
| SEM Analysis | No discernible difference in silver deposition (predicate expected to have robust deposition) | Silver deposition on dentin and in tubules between Centrix SDF and Elevate SDF showed no discernible difference based on SEM analyses. Significant deposits of silver on cut surface of tooth and within dentinal tubules. | Identical. Confirms similar physical mechanism of action (tubule occlusion). |
| Fluoride Release | 0.024 +/- 0.006 ppmF/mm² (predicate device) | 0.023 +/- 0.003 ppmF/mm² | Identical. No statistical difference confirmed equivalent fluoride release. |
| Dentin Permeability Reduction | 97.5% +/- 2.5% (predicate device) | 97.5% +/- 4.3% | Identical. Both devices reduced dentin permeability by an average of 97.5%. This is a key functional performance criterion directly related to the indication for use. |
| Chemical Composition Profile | Nearly Identical (predicate device) | Strong match between subject and predicate device via MS analysis for chemical composition. | Nearly identical. Confirmed by Mass Spectrometry. Differences in colorant (Fast Green FCF Dye vs. FD&C Blue 1) are noted but considered minor and not impacting substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the sense of a clinical trial for performance. Instead, it describes various laboratory and in vitro/in vivo (animal) studies for substantial equivalence.
- Cytotoxicity (ISO 10993-5): No specific sample size mentioned, likely standardized by the ISO method.
- Skin Sensitization (ISO 10993-10): No specific sample size mentioned, likely standardized by the ISO method (typically animal models).
- Irritation (ISO 10993-23): No specific sample size mentioned, likely standardized by the ISO method (typically animal models for oral mucosa).
- Acute Systemic Toxicity (ISO 10993-11): No specific sample size mentioned, likely standardized by the ISO method (typically animal models like rats or mice).
- SEM Analysis: "Human tooth samples" used. Number not specified.
- Fluoride Release Testing: "SDF treated tooth cross sections" used. Number not specified.
- Dentin Permeability: "Human molar teeth samples" used. Number not specified, but the results include standard deviations, implying a sample size greater than one.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that these are bench and preclinical studies for a 510(k), they are generally prospective laboratory studies. "Human molar teeth samples" would typically be ethically sourced from dental extractions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is generally not applicable to a 510(k) submission for substantial equivalence based on bench/preclinical testing. There is no "ground truth" established by experts in the context of interpreting images or clinical outcomes data. The "ground truth" for the tests mentioned (e.g., cytotoxicity, fluoride release, dentin permeability) is determined by the objective measurements and protocols of the respective ISO standards or laboratory methodologies.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human readers or expert consensus on qualitative data (e.g., image interpretation, clinical diagnosis). The studies presented are objective, quantitative laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the performance of human readers, typically in interpreting medical images, with and without AI assistance. The device in question (Centrix FluoroSilver Silver Diamine Fluoride 38%) is a chemical product for treating dental hypersensitivity, not an imaging or diagnostic AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a chemical substance, not a software algorithm or an AI device. The term "standalone performance" for an algorithm does not apply here. The performance of the substance itself was evaluated.
7. The Type of Ground Truth Used
The "ground truth" used for these substantial equivalence tests were objective, quantitative measurements and observations derived from standardized laboratory tests:
- Cytotoxicity: Observation of cellular response in vitro according to ISO 10993-5.
- Skin Sensitization: Dermal response in animal models according to ISO 10993-10.
- Irritation: Mucosal response in animal models according to ISO 10993-23.
- Acute Systemic Toxicity: Clinical observations and necropsy findings in animal models according to ISO 10993-11.
- SEM Analysis: Direct microscopic observation of silver deposition on tooth samples.
- Fluoride Release Testing: Quantitative measurement of fluoride concentration.
- Dentin Permeability: Quantitative measurement of water flow through dentin.
- Chemical Identity Testing: Mass Spectrometry data for chemical composition.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm. The device is a chemical product.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as above.
§ 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.