ORAL POTENTIAL METER (OPM) by PERTEC OF WISCONSIN, INC.

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.

Device Description

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

AI/ML Overview

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."

Acceptance Criteria (Threshold for "potential caries")	Reported Device Performance
Measurements above 10 millivolts	N/A (Device provides these measurements)
Measurements above 1 microamp	N/A (Device provides these measurements)
Measurements above 0.01 microwatts x seconds	N/A (Device provides these measurements)

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.

Summary

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Image /page/0/Picture/2 description: The image shows a black and white graphic. On the left side of the image, there is a stylized design that appears to be a logo or emblem. The design consists of curved lines and shapes, creating an abstract and flowing form. The word "DEZAR" is written vertically along the side of the design. To the right of the design, there is a horizontal line.

SEP 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Douglas L. Cook, DDS, SC Pertec of Wisconsin, Incorporated 10971 Clinic Road Suring, Wisconsin 54174 USA

Re : K982105 Trade Name: Oral Potential Meter (OPM) " Regulatory Class: II Product Code: LFC Dated: June 24, 1998 Received: July 31, 1998

Dear Dr. Cook:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੈ 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 regulation 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 requlations.

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Page 2 - Dr. Cook

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 regulation (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 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.fdaj.gov/cdrh/dsmamairr: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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510(K) Number (if known): K982105

Device Name: Oral Potential Meter

Indications For Use: Caries detection Device

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number

Regulation Number and Section

§ 872.1740 Caries detection device.

(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.