Search Results
Found 2 results
510(k) Data Aggregation
(6 days)
CARIESCAN LTD.
For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
Not Found
This document only contains marketing and regulatory information and does not contain the information required to answer the request. The document is a 510(k) premarket notification approval letter for the CarieScan PRO device. It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory requirements. It doesn't include details about acceptance criteria or specific study results beyond the general "indications for use."
Ask a specific question about this device
(285 days)
CARIESCAN LTD.
For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
This submission is for a handheld dental caries detection device which uses the AC impedance spectroscopy technique (ACIST). Single use disposal sensors are connected to the handheld device. The sensor is placed on the tooth site to be measured and a metal lip hook is placed on the patients lip, a small electrical current is passed between the sensor and the lip hook, the signals returned indicate any mineral changes in the tooth structure.
The CarieScan PRO is a handheld dental caries detection device that uses AC impedance spectroscopy. The device's performance was compared to a predicate device, DIAGNOdent 2095, which uses laser fluorescence.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Predicate: DIAGNOdent 2095) | Reported Device Performance (CarieScan PRO) |
|---|---|---|
| Sensitivity | 80% | 92.5% |
| Specificity | 52% | 92.5% |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the CarieScan PRO's performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor does it report any effect size for human readers improving with AI vs. without AI assistance. The study described focuses on standalone device performance compared to a predicate device.
6. Standalone Performance
Yes, a standalone performance study was done. The reported sensitivity and specificity of 92.5% for the CarieScan PRO are standalone performance metrics, indicating the algorithm's performance without human-in-the-loop assistance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set
The document does not provide information about the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set was established.
Ask a specific question about this device
Page 1 of 1