(265 days)
To aid the dental professional in the visualization of carious lesions.
BlueCheck™ Caries Detection & Monitoring is a solution containing colored agents that, when applied to tooth surfaces following a dental prophylaxis procedure, binds to surface porosities utilizing natural hydroxyapatite-binding chemistry of the protein component of the device. This allows dental professionals to observe the visual change in tooth surface color as blue on accessible tooth surfaces. BlueCheck is intended to be used in routine dental examinations as a diagnostic tool that assists dental professionals to visualize and assess caries. BlueCheck is supplied as a liquid product in single use vials (in a pack of 10 vials).
The provided text is a 510(k) summary for the BlueCheck™ Caries Detection & Monitoring device. It focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technology, and performance data from non-clinical testing.
Crucially, this document does not contain information about the device's specific performance metrics against pre-defined acceptance criteria from a human-in-the-loop or standalone study using a clinical test set. It discusses non-clinical performance testing related to removal from tooth surface after rinsing and brushing, and risk assessments/viral inactivation studies.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and the study proving the device meets them in the format you've requested for the following reasons:
- No Acceptance Criteria or Performance Data for Diagnostic Accuracy: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) for the device's diagnostic performance in identifying carious lesions. It states "Performance studies were conducted to demonstrate that the subject device has been removed from the tooth surface after rinsing, brushing with toothpaste containing sodium lauryl sulfate (SLS) and action of saliva," which relates to device residue, not diagnostic accuracy.
- No Clinical Study Details: There is no mention of a clinical test set, an MRMC study, standalone performance, the number of experts, adjudication methods, or how ground truth was established for diagnostic performance. The "Performance Data" section solely refers to non-clinical tests.
- No Training Set Information: The document is a 510(k) summary for a device (a liquid solution with staining agents), not an AI algorithm. Therefore, there is no concept of a "training set" in the context of machine learning.
The 510(k) process for this type of device (a diagnostic staining solution) typically relies on demonstrating substantial equivalence through:
- Similar Indications for Use: As shown in the Indications for Use sections.
- Similar Technological Characteristics: Explained in the "EQUIVALENCE TO MARKETED DEVICES" table, comparing the subject device to the predicate and reference devices in terms of formulation, application, detection method, etc.
- Acceptable Non-Clinical Performance & Safety: This includes things like biocompatibility, shelf-life, and in this case, the ability of the stain to be removed post-use.
In summary, the provided text describes the regulatory clearance process for a chemical diagnostic aid, not a software/AI-driven medical device that would have specific diagnostic accuracy metrics and associated clinical study details as per your request.
If this were an AI/software device, the information you requested would typically be found in a clinical performance study report, which is usually part of the 510(k) submission but not always fully detailed in the public 510(k) summary.
§ 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.