(89 days)
A visual aid for the identification of carious dentin.
Vista Dyes are colored agents that when applied to the suspected carious areas of the tooth stains the carious dentin. The method of operation and placement of Vista Dyes are similar to that of the primary predicate and reference device, Caries Finder (K955445) and Pulpdent Snoop (K964430), respectively. A drop of the dye is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the carious cavity.
The device described is "Vista Dyes", a caries detection device. Based on the provided text, there is no detailed study provided that presents specific acceptance criteria and device performance metrics in a quantitative manner. The submission primarily relies on demonstrating substantial equivalence to predicate devices (Caries Finder and Pulpdent Snoop) based on identical indications for use, technological characteristics, and methods of application, rather than presenting a performance study with specific acceptance criteria.
The document states: "Clinical performance is not deemed necessary to support the substantial equivalence of the proposed device." Therefore, there is no information about acceptance criteria, reported device performance, sample size, ground truth establishment, or expert involvement for a performance study.
However, based on the information provided, we can infer some aspects of what would typically be considered "acceptance criteria" through the comparative analysis with predicate devices.
Here's an analysis of the provided information in response to your questions:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria or reported device performance (e.g., sensitivity, specificity) were provided in the document. The substantial equivalence argument serves as the "acceptance criteria" here, meaning that the device's characteristics must be sufficiently similar to the predicate devices to not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical or performance test set was described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical or performance test set requiring expert ground truth was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or performance test set was described.
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
Not applicable. This device is a dye, not an AI-assisted device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dye, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No performance study requiring ground truth was conducted or described. The safety and effectiveness are established by substantial equivalence to legally marketed predicate devices, implying that the known performance characteristics of the predicate devices implicitly serve as a "ground truth" for what is acceptable.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.
Summary of Acceptance Criteria and Performance (Inferred from Substantial Equivalence):
| Acceptance Criteria Category | Reported Device Performance / Justification |
|---|---|
| Indications for Use | Identical to predicate device (Caries Finder): "A visual aid for the identification of infected carious dentin." |
| Mechanism of Action | Identical to predicate: "Visible staining of carious dentin." |
| Material Composition | - Red & Green Dyes: 99% propylene glycol, 1% dye (acid red 52 or FD&C green). Identical to predicate. |
- Blue Dye: 99% distilled water, 1% methylene blue dye. Differs from primary predicate (which uses propylene glycol) but is equivalent to reference device (Pulpdent Snoop). |
| Physical Properties | Colored aqueous liquid. Identical to predicate. |
| Chemical Properties | 1% dye concentration. Identical to predicate. |
| Intended Use | Same target population and anatomical site. Identical to predicate. |
| Packaging Configuration | - Dropper bottles: Identical to predicate. - Prefilled 1.2mL syringes: Additional configuration, deemed not to raise new concerns as it simplifies application and is common in dentistry. |
| Sterility | Non-sterile. Identical to predicate. |
| Shelf-Life | 3 years. Based on accelerated testing and ongoing real-time aging. Identical to predicate. |
| Prescription/OTC Use | Prescription use only. Identical to predicate. |
| Biocompatibility | Confirmed via literature review, LD50 analysis of constituents, existing FDA data, and longstanding use of predicate without significant adverse events (MAUDE database). |
| Safety and Effectiveness | Demonstrated through substantial equivalence to legally marketed predicate devices, with no new questions of safety or effectiveness raised by minor differences. |
In essence, the "study" for Vista Dyes was a substantial equivalence comparison demonstrating that its characteristics are similar enough to existing, legally marketed devices that it does not require new clinical performance data.
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.