The TCM Endo 20 is a transportable, cord connected equipment, provided with a plastic enclosure which has two connection ports for the footswitch and the electronic motor. It is a microprocessor controlled electronic motor system which controls the rotational speed and the torque of the motor. The rotational speed is constant until the torque reaches the adjusted level. In order to protect the rimmer, you can choose between two torque controlling modes -the Automatic Limiter (AL) and the Automatic Reverse (AR) mode. The electronic motor has a standard E-type handpiece adapter that accepts any E-type contra angle and handpiece (E-fitting).

AI/ML Overview

The provided text is a 510(k) summary for the NOUVAG AG TCM Endo 20 device. It states that the device is substantially equivalent to a previously cleared device (NOUVAG AG TCM Endo V K042822). The summary explicitly states: "The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product."

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Study for NOUVAG AG TCM Endo 20

This 510(k) submission for the NOUVAG AG TCM Endo 20 is for a dental root treatment device. As such, the primary method for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than a clinical study with detailed performance metrics and acceptance criteria as would be seen for novel or high-risk devices. The submission indicates that the device has been designed and tested to applicable safety standards and is substantially equivalent to other legally marketed devices in the United States and functions in a similar manner for the same intended use.

Therefore, the "acceptance criteria" here are generally related to meeting recognized safety standards and demonstrating that the device's technical characteristics and intended use are comparable to the predicate. The "study" proving this largely relies on engineering and performance testing to ensure it operates equivalently to the predicate, not a clinical trial measuring diagnostic accuracy or treatment efficacy.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical and electrical safety via applicable standards.	"The TCM Endo 20 has been designed and tested to applicable safety standards."
Functional equivalence to the predicate device (TCM Endo V K042822).	"The TCM Endo 20 functions in a manner similar and is intended for the same use as the TCM Endo V (Predicate device)."
No new issues of safety, effectiveness, or performance.	"The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product."
Compliance with regulatory requirements (GMP, labeling, etc.).	(Implicitly asserted by submitting for 510(k) clearance)

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the traditional sense (e.g., patient data). The testing mentioned is primarily non-clinical, likely engineering and performance testing to verify adherence to safety standards and functional specifications. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable or provided for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and not provided. The substantial equivalence argument relies on comparing device specifications and intended use to a predicate, not on a clinical ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set with adjudicated ground truth is described.

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

Not applicable. This device is an endodontic motor, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm; it is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this device filing, the "ground truth" for substantial equivalence is primarily the established safety and effectiveness profile of the predicate device, demonstrated through non-clinical testing against engineering specifications and applicable standards for the new device.

8. The sample size for the training set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

K081191

NOUVAG AG TCM Endo 20

510(k) Notification April 16, 2008 :

: :

SECTION 5

AUG - 7 2008

510(k) Summary

Submitter: NOUVAG AG St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland

Contact Person: Markus Gemperle Quality Manager / RA Phone +41 71 846 66 00 +41 71 845 35 36 Fax

Date Summary Prepared: April 16, 2008

Device Name:

Proprietary Name TCM Endo 20

Common Name Endodontic Device

Classification Name Handpiece, Direct Drive, Ac-powered (per 21 CFR section 872.4200)

Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

NOUVAG AG TCM Endo V K042822, Cleared on 12/22/2004

{1}------------------------------------------------

Device Description:

In order to protect the rimmer, you can choose between two torque controlling modes -the Automatic Limiter (AL) and the Automatic Reverse (AR) mode.

The electronic motor has a standard E-type handpiece adapter that accepts any E-type contra angle and handpiece (E-fitting).

The following parameters can be set by the user:

"Speed" increase or decrease rotational speed
"Torque" select torque maximum
-"Motor" -- Switch on/off electronic motor
"Ratio" Select ratio of the contra angle -
-"Symbol reverse" - Select rotating direction: R (Right) clockwise: L (Left, reverse) counterclockwise
-"Prog" - Select Program 1 to 9
-"AL/AR" - Choose between AL- and AR- mode

Sterility:

Motor and motor cable: Sterility by user up to 134°C.

Intended use of the Devices:

The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.

Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:

The TCM Endo 20 is substantially equivalent to other legally marketed devices in the United States. The TCM Endo 20 functions in a manner similar and is intended for the same use as the TCM Endo V (Predicate device)

Brief summary of nonclinical tests and results:

The TCM Endo 20 has been designed and tested to applicable safety standards. The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2008

NOUVAG AG C/O Ms. Erich Forster Quality Manager / Regulatory Affairs INTRATest GmbH Reusswehrstrasse 1 Gebenstorf CH-5412 SWITZERLAND

Re: K081191

Trade/Device Names: TCM Endo 20 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: July 8, 2008 Reccived: July 14, 2008

Dear Mr. Forster:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Forster

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registertion and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,

TH Normuly ferdi r-2

pxu

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K081191

510(k) Number (if known):

Device Name: TCM Endo 20

Indications for Use:

The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

Prescription use X
(per 21 CFR 801.109)

Over-The-Counter Use_

Susan Ryner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

1971-191 510(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.