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The intended use of the endodontic analyzer is 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 Endo Analyzer, Model 8005, Modified 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 analyzer which is designed to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth) and to locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit is battery operated using six (6) 1.5 volt size AA alkaline batteries. An automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The unit may be used in either of two modes, V.S. as a pulp tester or A.F. as an apex locator. The endodontic analyzer is controlled by a microprocessor and the handpiece and cord assembly are completely removable. The probes, lip clips and file clips used with the device are autoclavable.

This 510(k) summary (K990225) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) summary for a modified endodontic analyzer device (Endo Analyzer, Model 8005, Modified). It primarily focuses on demonstrating substantial equivalence to a predicate device based on similar function and intended use.

Here's what the document does include and what it lacks in relation to your request:

Information Present:

• Device Name: Endo Analyzer, Model 8005, Modified
• Intended Use: To test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.
• Predicate Device: Analytic Endodontics, Endo Analyzer, Model 8005
• Submission Date: January 1999

Missing Information (Crucial for your request):

The document does not contain any details about acceptance criteria, performance studies, or clinical data. This type of information is typically found in the full 510(k) submission, not necessarily in the summary provided to the FDA for public reference. Therefore, I cannot construct the table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement.

To obtain the requested information, you would need to access the complete 510(k) submission for K990225, which would include performance data, clinical testing protocols, and results.

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