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.

Device Description

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.

AI/ML Overview

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.

Summary

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Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

September 1997 Date Summary Prepared:

Device Name:

Trade Name Endo Analyzer, Model 8005 .
Common Name Endodontic Analyzer .
Classification Name Pulp Tester, per 21 CFR § 872.1720 .

Devices for Which Substantial Equivalence is Claimed:

Analytic Technology Corporation, Apex Finder A.F.A. .
Analytic Technology Corporation, Vitality Scanner .

Device Description:

Intended Use of the Device:

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.

Substantial Equivalence:

The endodontic analyzer is substantially equivalent to several other legally marketed devices in the United States. The Vitality Scanner and Apex Finder A.F.A. marketed by Analytic Technology Corporation function in a manner similar to and are intended for the same use as the product manufactured by Analytic Technology Corporation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 1997

Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

K973439 Re: Endo Analyzer, Model 8005 Trade Name: Regulatory Class: II Product Code: EAT September 8, 1997 Dated: Received: September 10, 1997

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to we have telewoa referenced above and we have determined the marros is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Boswell

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section I - Indications for Use

Rangala 510(k) Number:

Device Name: Endo Analyzer, Model 8005

Indications for Use:

(Division Sign-Off) Parailor Scott . Division of Dental, Infection Control, and General Hospital Devices

510(k) Number_4973439

Regulation Number and Section

§ 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.