The APEX POINTER+ is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.

AI/ML Overview

The provided text does not describe acceptance criteria for the device, nor does it detail a specific study proving the device meets acceptance criteria in the manner typically expected for a medical device efficacy study (e.g., performance metrics compared against a predefined threshold).

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (Techdent's APX21, K073185). The "performance" section describes subjective observations from an expert and compliance with general safety standards.

Therefore, many of the requested items cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative metrics. The primary "acceptance" seems to be substantial equivalence to the predicate device.	- Good ergonomics (observed by Prof. Machetou)
	- Good precision on new treatments and re-treatments (observed by Prof. Machetou)
	- Good audible signal (observed by Prof. Machetou)
	- Preferably used on wet canal without exception of liquid (observed by Prof. Machetou)
	- Excellent visibility on the screen (observed by Prof. Machetou)
	- Biocompatible and autoclavable components contacting patient.
Electrical safety and EMC tested per EN 60601	System was Electrical safety and EMC tested per EN 60601.

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

Sample size: Not specified. The "test" mentioned is an evaluation by a single expert, not a formal study with a defined sample size.
Data provenance: The evaluation was conducted in a clinical setting ("in his clinic") by Prof. Pierre Machetou. The country of origin of the data is not specified, but the manufacturer is French. It appears to be a prospective evaluation by an expert.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: One (Prof. Pierre Machetou).
Qualifications: "renowned worldwide for his expertise in Endodontics."

4. Adjudication method for the test set:

Not applicable. The evaluation was performed by a single expert, not a process requiring adjudication among multiple reviewers.

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:

A MRMC study was not conducted. The device is an electronic apex locator, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

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

The device itself is a standalone electronic apex locator. Its performance evaluation (as far as described) does not involve a human interpreting its output in comparison to a human interpreting things manually. Instead, the human (Prof. Machetou) is assessing the device's overall performance.

7. The type of ground truth used:

The document does not explicitly define a formal "ground truth" used for a quantitative performance study. The expert's observations ("Good precision") serve as a qualitative assessment of accuracy. For an apex locator, a typical ground truth might involve radiographic measurements or direct visualization post-extraction, but this is not described in the document.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI/machine learning model that typically has a "training set."

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

Not applicable, as there is no "training set" for this type of device.

Summary

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

1<103123

MAR 1 0 2011

Image /page/0/Picture/2 description: The image shows a logo with the letters "MM" stacked vertically. Below the letters, the words "MICRO" and "MIG" are written on top of each other. The logo has a simple, bold design with a black and white color scheme. The letters and words are all capitalized.

SECTION 5: 510(k) Summary

Submitter

Micro-Mega Société Anonyme 5 - 12 rue du tunnel 25006 BESANCON CEDEX FRANCE Tel : +33 (0)3 81 54 42 42 Fax : +33 (0)3 81 54 42 49

Contact Person

Philippe Conche 5-12 rue du tunnel 25006 BESANCON CEDEX FRANCE . Tel : +33 (0)3 81 54 42 29 Fax : +33 (0)3 81 54 42 49 Email : philippe.conche@micro-mega.com

Date Prepared

October, 2010

Device Information

Trade name: APEX POINTER+ Common name: Electronic Apex Locator Classification Name: locator, root apex Review Panel: Dental Product Code: LOY Device Class: Unclassified (Pre-Amendment)

Devices to which substantial equivalence is claimed:

12.	(0(k) number Trade or propriety name1 19 2000 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100	Manufacturer
		TECHDENT
K073185	APX21	TECHNOLOGIES.
		LTD

Device Description

The APEX POINTER+ is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.

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

Indications for Use

The APEX POINTER+ is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.

Performance

Techdent's APX21 (K073185) is an OEM Products of Micro-Mega's APEX POINTER+ (same design excepted color of external casing) and are both manufactured by Techdent; it is the reason why the performances are identical.

Prof. Pierre Machetou, who is renowned worldwide for his expertise in Endodontics, has tested the APX21 device in his clinic, and noted the following t

. Good ergonomics
Good precision on new treatments and re-treatments. 다.
I Good audible signal
I Should preferably be used on wet canal without exception of liquid
트 Excellent visibility on the screen

All system components that come in contact with the treated patient are biocompatible and autoclaveable.

System was Electrical safety and EMC tested per EN 60601.

Conclusion

Micro-Mega's APEX POINTER+ , subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended.

The APEX POINTER+ has the same intended use and fundamental scientific technology as its predicate device APX21 (Techdent).

The APEX POINTER+ was compared against its predicate, and was found to be substantially equivalent.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service -

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Conche Philippe Regulatory Affairs Manager Micro-Mega Societe Anonyme 5-12 rue du tunnel 25006 BESANCON CEDEX FRANCE

MAR 1 0 201

Re: K103123

Trade/Device Name: APEX POINTER+ - Electronic Apex Locator Regulatory Class: Unclassified Product Code: LQY Dated: February 22, 2011 Received: March 3, 2011

Dear Mr. Philippe:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Philippe

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: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

Susan Kinney

Anthony D. Watson, B.S., M.S., M.B.A. Director

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

Enclosure

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

SECTION 4: Indications for Use

K103123 510(k) Number:

Device Name:

APEX POINTER+ - Electronic Apex Locator

Intended Use:

The APEX POINTER+ is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point.

Indications for Use:

The APEX POINTER+ is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.

Contra Indications:

Do not use the APEX POINTER+ on patients with implanted heart pacemakers or other equipment which have been warned against use of small electrical appliances.

Prescription Use AND/OR Over-The-Counter Use ਵ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) :

Concurrence of CDRH, Office of Device Evaluation(ODE) Page 1 of 1 Super (Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k10323

Regulation Number and Section

N/A