(89 days)
The Endo Analyzer, Model 8005, 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 and to locate the apical foramen of a root canal during root canal treatment. The unit is battery operated using three (3) 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 vitality scanner 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 handpiece and cord assembly, including the vitality scanner tips and lip clip used with the device, are autoclavable.
The provided text is a 510(k) summary for a medical device called the "Endo Analyzer, Model 8005", which is an endodontic analyzer designed to test tooth vitality and locate the apical foramen. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.
The document primarily focuses on:
- Device Description and Intended Use: Explaining what the device is, how it works, and its purpose.
- Substantial Equivalence: Comparing the device to other legally marketed devices (Analytic Technology Corporation's Apex Finder A.F.A. and Vitality Scanner) to demonstrate that it functions similarly and has the same intended use.
- Regulatory Information: A letter from the FDA confirming the device's 510(k) clearance based on substantial equivalence to predicate devices, and outlining general regulatory requirements.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided text.
The document is a regulatory submission for 510(k) clearance, which typically relies on demonstrating substantial equivalence to existing devices rather than presenting new clinical study data with defined acceptance criteria for a novel performance claim. If a performance study was conducted, its details would be in a separate section or document not included here.
§ 872.1720 Pulp tester.
(a)
Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.