The TCM 3000's and TCM Endo's primary components are (1) a console; (2) a motor; (3) a microprocessor; (4) a foot pedal; and (5) an electric cord and plug. The TCM 3000 and TCM Endo is not supplied with dental drills or contra-angles or contra-angles torque wrenches, which are also called dental hand pieces. The Micromotor has a standard E-Type coupling that will fit any E-Type hand pieces and contra-angles.

The console houses the microprocessor and the motor. The buttons for setting the motor speed, contra-angle reduction ratio, motor torque are located on the front panel of the console. The buttons that may be used to start and stop the motor and change the cut-direction of the drill also are located on the front panel. The port connections for the contra-angles and the foot pedal and the main power switch are located on the back of the console.

A lever is located on the foot pedal for starting and stopping the motor. For the second version of the foot pedal the lever also can adjust the motor speed. The TCM 3000/Endo contains an audible alarm that sounds when the drill is turning in the reverse- cut direction.

The TCM 3000/Endo requires an AC current of 115V or 230V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is attached to the back of the console.

AI/ML Overview

The provided document is a 510(k) summary for the Nouvag AG's TCM 3000/Endo device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria and performance results in the way a novel device might. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not typically found in this kind of regulatory filing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain specific quantitative acceptance criteria or a table of reported device performance in the context of a clinical study. The basis for clearance is "substantial equivalence" to a predicate device, meaning it's demonstrated to be as safe and effective as a device already on the market.

2. Sample Size Used for the Test Set and Data Provenance:

No test set (in the context of a clinical trial for performance evaluation) is mentioned. The submission relies on a comparison of technological characteristics and intended use to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. No ground truth for a test set was established as part of this submission.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is a mechanical dental instrument, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable. The submission is based on substantial equivalence, not on establishing a new ground truth for a novel device's performance. The "ground truth" in this context is the safety and effectiveness of the predicate device, which has a "long history of safe use."

8. The Sample Size for the Training Set:

Not applicable. No training set for an algorithm was used.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set for an algorithm was used.

Summary of Device Acceptance Criteria (Implied by Substantial Equivalence):

While not explicitly stated as "acceptance criteria," the submission argues that the TCM 3000/Endo meets the following for substantial equivalence to the NOUVAG's Micro-Dispenser 7000 and 8000 (K954722):

Criterion Category	Implied Acceptance
Intended Use	The device is substantially equivalent if its intended use is for "microprocessor-controlled dental drilling and torque-controlled system," similar to the predicate. Reported Performance/Claim: "The TCM 3000/Endo and the Micro-Dispenser 7000/8000 have the same general intended use: microprocessor-controlled dental drilling and torque-controlled system."
Indications for Use	The device is substantially equivalent if its indications are similar to the predicate, specifically for "dental implantation and microsurgery." Reported Performance/Claim: "These devices also have very similar indications: dental implantation and oral or microsurgery."
Technological Characteristics	The device is substantially equivalent if its primary components (console, motor, microprocessor, foot pedal, electric cord), standard E-Type coupling, and operational features (buttons for speed/ratio/torque, start/stop, cut-direction, audible alarm for reverse operation, AC current requirement) are similar to the predicate. Minor differences should not raise new safety or effectiveness concerns. Reported Performance/Claim: "The TCM 3000/Endo and the Micro-Dispenser have very similar technological characteristics. More specifically, these dental drilling systems have the following features: (1) buttons on the console... (2) a foot pedal... (3) motor torques that are preset... (4) safety-overload protection; and (5) they require AC current. Both are microprocessor controlled. Neither device is supplied with drills or contra-angles. Both devices can be used with any E-type contra-angles. Although there are some minor differences in their technological characteristics... These differences do not present any new issues of safety or effectiveness."
Principles of Operation	The device is substantially equivalent if its operational principles—setting motor speed, contra-angle reduction ratio, motor torque, AS-Torque-Driver Mode, starting/stopping with foot pedal/buttons, forward/reverse cut direction—are similar to the predicate. Reported Performance/Claim: "In addition, these devices have the same principles of operation. The operator of the device sets the motor speed, contra-angle reduction ratio, and the torque-levels and operates the drill by pushing buttons on the console or on the foot pedal."
Safety and Effectiveness	The device is substantially equivalent if its safety and effectiveness are based on the predicate device's established record, and any differences do not raise new safety or effectiveness concerns. Reported Performance/Claim: "The safety or effectiveness of the TCM 3000/Endo is based on the safety or efficacy of the predicate device... These differences do not present any new issues of safety or effectiveness. Thus, the TCM 3000/Endo is substantially equivalent to the Micro-Dispenser 7000/8000." Bio-compatibility of non-supplied components (drills, contra-angles) is covered by their "long history of safe use."

Study Proving Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is a comparison to a predicate device (NOUVAG's Micro-Dispenser 7000 and 8000, K954722) to establish substantial equivalence. This is a regulatory pathway that relies on demonstrating that the new device has the same intended use, similar technological characteristics, and similar principles of operation as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.

Key conclusions from the submission:

The TCM 3000/Endo is declared substantially equivalent to the predicate device because:
- They share the same general intended use and very similar indications.
- They have very similar technological characteristics (e.g., microprocessor-controlled, buttons for settings, foot pedal, safety features, E-type compatibility, AC current).
- They operate on the same principles.
- Minor differences (e.g., specific contra-angle reduction-ratios, pre-selectable torque levels, irrigation pump, foot control variation) do not introduce new issues of safety or effectiveness.
- The biocompatibility of components (drills and contra-angles) not supplied with the device is addressed by their "long history of safe use."

In essence, the "study" is the 510(k) submission itself, which systematically compares the new device to the predicate across various attributes to demonstrate that it meets the regulatory standard of substantial equivalence. This is not a clinical trial in the traditional sense, but rather a regulatory assessment.

Summary

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K981679

Attachment 8

510(k) SUMMARY FOR NOUVAG AG'S TCM 3000/Endo

Submittors's Name, Address, Telephone Number and Contact Person

Nouvag AG St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland

Contact:	Margit EschbaumerINTERTest Systems GmbH.	Benno FreiNouvag AG
Phone:	08341 91 5050	071 845 35 35
Facsimile:	08341 91 5059	071 845 35 36
As Regulatory Counsel to Nouvag.

Date Prepared

April 28, 1998

Name of Device

TCM 3000 and TCM Endo

Common or Usual Name

Microprocessor-Controlled Dental Drilling and Torque-controlled System

Classification Name

Dental Handpiece and Accessories (21 C.F.R. § 872.4200)

Predicate Devices

NOUVAG's Micro-Dispenser 7000 and 8000 (K954722)

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Intended Use

Nouvag AG's ("Nouvag") TCM 3000 and TCM Endo is a microprocessorcontrolled dental hand piece with controlled electric motor-torque. The TCM 3000 and TCM Endo is intended to be used for dental drilling and tightening of the various types of screws during dental implantation and microsurgery. The TCM 3000 and TCM Endo are the same device with the same components. For marketing reason they just have different names.

Technological Characteristics

The TCM 3000/Endo requires an AC current of 115V or 230V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is attached to the back of the console.

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Principles of Operation

The operator of the TCM 3000/Endo turns the main power switch to the .on" position to start the device. The operator then sets the motor speed, the contraangle reductions ratio and the motor torque by pressing buttons at the front panel of the console. The preset motor speed is displayed on the front panel. The built - in torque controller ensures that the drill is working constantly at the pre - selected motor torque and the pre - selected drill speed.

The operator also has the option of setting the AS - Torque - Driver Mode. This function is used for tightening and releasing the screws. As soon as the motor torque is equal to the pre-selected value, the motor will automatically shut-off. By utilizing this torque driver mode, the operator can avoid the risk of under - or over tightening of screws.

The operator starts the motor with the foot pedal or the "motor" button. There are two different foot pedals available: one with just the start/stop foot switch, the second foot control with the variable speed foot pedal. In this case the operator starts cutting with the drill by depressing the lever on the foot pedal; the drill continues to cut as long as the lever remains depressed. The drill stops immediately when the operator releases the foot lever.

The operator can use the drill in the forward-cut direction or the reversecut direction pressing the "FORW/REV" button on the control panel. The green LED indicator light on the "FORW/REV" button will illuminate and an alarm will sound when the drill turns in the reverse-cut direction.

The TCM 3000/Endo microprocessor implements the operator's commands, displays the motor speed, and sounds an alarm if there is an electric overload or the drill is turning in the reverse cut direction. The microprocessor has no external user interface; it simply implements the operator's commands. The preselected drill speed and motor torque for each drill and the torque value are retained in memory if the main switch is shut off.

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Summary of the Basis for the Finding of Substantial Equivalence

The safety or effectiveness of the TCM 3000/Endo is based on the safety or efficacy of the predicate device.

The TCM 3000/Endo and the Micro-Dispenser 7000/8000 have the same general intended use: microprocessor-controlled dental drilling and torque-controlled system. These devices also have very similar indications: dental implantation and oral or microsurgery. In addition, these devices have the same principles of operation. The operator of the device sets the motor speed, contra-angle reduction ratio, and the torque-levels and operates the drill by pushing buttons on the console or on the foot pedal. The operator of the Micro-Dispenser 7000/8000 has the option of operating the drill(s) and changing the cut directions of the drill(s) by using either the hand control buttons on the front panel or the foot pedal. The operator of the TCM 3000/Endo can also use the hand control panel or the foot pedal, but only for start/stop function of the motor. The TCM 3000/Endo and the Micro-Dispenser 7000/8000's microprocessors implement the operator's commands.

The TCM 3000/Endo and the Micro-Dispenser have very similar technological characteristics. More specifically, these dental drilling systems have the following features: (1) buttons on the console for setting the motor speed, torque levels, contra-angle reduction ratios and starting and stopping the motor; (2) a foot pedal for starting and stopping the motor, (3) motor torques that are preset according to the selected contra-angle reduction, (4) safety-overload protection; and (5) they require AC current. Both are microprocessor controlled. Neither device is supplied with drills or contra-angles. Both devices can be used with any E-type contra-angles. Although there are some minor differences in their technological characteristics, namely their contra-angle reduction-ratios and their pre-selectable torque levels, as well their irrigation pump and their foot control. These differences do not present any new issues of safety or effectiveness. Thus, the TCM 3000/Endo is substantially equivalent to the Micro-Dispenser 7000/8000.

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The dental drills and contra-angles are the only components of the TCM 3000/Endo that may come into contact with the patient's body during dental implantation or microsurgery. As noted above, the TCM 3000/Endo is not supplied with the dental drills and E-type contra-angles. Therefore, the bio-compatibility of these products need not to be demonstrated in this submission. Nevertheless, the bio-compatibility of dental drills and contra-angles has been demonstrated by their long history of safe use.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Nouvag AG C/O Ms. Eschbaumer INTERTest Systems GmbH Sudetenstrabe 5 D-87600 Kaufbeuren GERMANY

K981679 Re : TCM 3000 and TCM Endo Trade Name: Requlatory Class: I Product Code: EFB Dated: November 20, 1998 Received: November 23, 1998

Dear Ms. Eschbaumer

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, Druq, 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 Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Eschbaumer

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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

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

Enclosure

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Page 7 of 7

510(k) Number (if known):	K981679
Device Name:	ICM 3000 / Endo
Indications For Use:

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

Conc urence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Formal 1-2-96)

Susan Rumpa

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

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.