Search Results

The Elements Diagnostic Unit is intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

The device is a battery-operated, endodontic diagnostic unit designed to be used in either of two modes, V as a pulp tester to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth), or A as an apex locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit uses a rechargeable battery pack, and can be used while the pack is charging. A remote satellite display that mirrors the values on the unit's graphic display can be attached to a chair, patient's bib or microscope for a more ergonomic monitoring of diagnostic status. To improve visibility and decrease eyestrain, the main body of the unit can be rotated from a vertical orientation to a 30° angle. The automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The endodontic diagnostic unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The remote satellite display and cord assembly are completely removable. The probes, lip clips and file clips used with the device are autoclavable.

The provided text does not contain information about specific acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or detailed study methodologies. The document is a 510(k) summary for the "Elements Diagnostic Unit," primarily focusing on establishing substantial equivalence to a predicate device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. The text describes the device's intended use and functionality, and states that it is substantially equivalent to a previously marketed device. There is no information about how this equivalence was demonstrated through specific performance testing or clinical studies with detailed acceptance criteria.

Information NOT Found in the Document:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results (effect size).
• Standalone algorithm performance results.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

Ask a specific question about this device