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Caries detection Device

The Oral Potential Meter aids the dental professional in detecting potential caries. Meaurements above 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dental professional to look at potentially carious leasions by also using other means, such as direct exploration, radiographs, etc. The OPM aids in determing potentially active caries and can not detect mineralized caries that have no potenial energy. Remineralized teeth are no longer considered carious.

The OPM is a device that measures and displays voltage and conducts through caries related to metallic restorations in the oral cavity. The dentist may be able to, on visual exam, detect caries at the margins or with x-ray under a restoration with these readings. It also provides a power measurement (energy or joules) integrated over a measured period of time and displays it. The meter has two probes that are used to make the measurements. One is a reference probe, Red, with push-button switch to turn on the meter and initiate the measurements. The other is used as the primary input, Black to the meter's electronics

This appears to be a 510(k) clearance letter from the FDA for an Oral Potential Meter (OPM) device, not a detailed study report. Therefore, much of the requested information about acceptance criteria, study design, and performance metrics cannot be directly extracted from the provided text. The document primarily focuses on the device's intended use and FDA's determination of substantial equivalence.

However, I can extract the following based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the "Indications For Use" and provides specific thresholds for the OPM readings that indicate a need for further examination by a dental professional. These thresholds act as the de facto acceptance criteria for the device's output, informing the user when to consider a "potential caries."

Note: The document does not provide a separate "Reported Device Performance" section in the sense of accuracy, sensitivity, or specificity against a reference standard. Instead, it describes what the device measures and how those measurements should be interpreted by a dental professional. The device's "performance" is its ability to provide these measurements.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document is a regulatory clearance letter, not a clinical study report.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

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:

• MRMC Study: Not mentioned or implied. The OPM is a diagnostic aid, not an AI-assisted reader system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance Study: Not mentioned or implied. The device is explicitly stated to "aid the dental professional" and requires the professional to "look at potentially carious lesions by also using other means." This indicates human-in-the-loop performance is integral to its intended use, rather than a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: Not specified in the provided text. The device's indications for use rely on the dental professional using "other means, such as direct exploration, radiographs, etc." to confirm caries. This suggests that existing clinical diagnostic methods would serve as the ultimate ground truth.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not specified.

Summary based on the provided text:

The provided document is an FDA 510(k) clearance letter for the Oral Potential Meter (OPM). It outlines the device's intended use and the specific measurement thresholds (10mV, 1µA, 0.01 microwatts x seconds) that signal a need for further dental professional investigation of potential caries. These thresholds serve as the practical "acceptance criteria" for the device's output. However, the document does not include details about specific studies, sample sizes, ground truth establishment, expert qualifications, or detailed performance metrics against a reference standard that would typically be found in a clinical study report. The FDA's clearance is based on a determination of "substantial equivalence" to a predicate device, which implies that the device's performance aligns with established clinical utility for this type of diagnostic aid.

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