(114 days)
The APX21 is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point. The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
The APX21 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.
Acceptance Criteria and Study Details for APX21 Electronic Apex Locator
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Range | Reported Performance (APX21) |
|---|---|---|
| Accuracy of apex localization | ±0.5 | Achieved "high rate of accuracy, falling well within the acceptable accuracy range criterion of ±0.5." |
| Stability | Unconditionally stable | "proved to be unconditionally stable" |
| Improved accuracy (narrowed range) | ±0.2 | "accuracy rates achieved with the APX21 In-Vivo were higher relative to the Root ZX, especially when unstable readings were taken into account and/or accuracy range criterion was narrowed down to ±0.2." |
2. Sample Size and Data Provenance
The document does not specify the exact sample size for the In-Vitro and In-Vivo studies for the APX21 or the Root ZX.
The data provenance is not explicitly stated in terms of country of origin, but the contact person for the submitter is located in Israel, suggesting the studies likely occurred there or under the oversight of individuals in Israel.
The studies were retrospective or prospective is not specified.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish the ground truth for the test set.
It mentions "Prof. Pierre Machetou, who is renowned worldwide for his expertise in Endodontics," tested the APX21 device in his clinic and noted observations, but it is not explicitly stated that he was the sole or primary expert for establishing objective ground truth for the comparative studies.
4. Adjudication Method
The adjudication method for the test set is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study compares the APX21 against a predicate device (Morita's Root ZX) in terms of accuracy and stability, but not directly on how human readers' performance improves with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done for the APX21. The "In-Vitro and In-Vivo studies" evaluated the performance of the APX21 and compared it to the predicate device, the Root ZX, specifically focusing on "accuracy and stability." The reported accuracy rates are directly attributable to the device itself.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly defined in the provided text. It can be inferred that the "accuracy" measurements were based on a definitive endpoint for the apex, likely established through either physical measurements in vitro or direct visualization/measurement in vivo (e.g., radiography, direct measurement during surgical exposure if applicable, or a highly reliable gold standard method in endodontics).
8. Sample Size for the Training Set
The document does not specify a training set sample size or mention the use of a training set for the device, as electronic apex locators typically rely on bio-impedance principles rather than machine learning models that require explicit training data.
9. How the Ground Truth for the Training Set Was Established
As the device described (APX21) relies on bio-impedance principles and not a machine learning model, a "training set" in the conventional sense is not applicable, and therefore, how its ground truth was established is not relevant to its design.
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K073185
MAR - 6 2008
SECTION 5: 510(k) Summary
Submitter
Techdent Technologies Ltd. 55ª Weizman St. 22402 Nahariya ISRAEL Tel: +972 (54) 437-4201 Fax: +972 (4) 951-1561 E-mail: icrohn@netvision.net.il
Contact Person
Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187, ISRAEL Tel: +972 (4) 994-7880 Fax: +972 (4) 994-4224 E-mail: benny(@arazygroup.com
Date Prepared
November, 2007
Device Information
Trade name: APX21 Common name: Electronic Apex Locator Classification Name: locator, root apex Review Panel: Dental Product Code: LQY Device Class: Unclassified (Pre-Amendment)
Devices to which substantial equivalence is claimed:
| A LA P S S S S BALL A | Class of the controlled of the count of the count of the count of the many would be and the many of the first for the may be any and.PP PARACE: POST THE THECompany of the status and the same of the comments of the comments ofния поставите се страници и принавшие на сединина в седении принади и води и видеоA Comments of Comments of Children Comments of Children Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments oand and with and the manufacturer the many would be and the many of the many of the many of the many of the may | gamila cinterAND PRODUCTION CONSULTION CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTI |
|---|
Device Description
The APX21 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.
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Indications for Use
The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
Performance
Prof. Pierre Machetou, who is renowned worldwide for his expertise in Endodontics, has tested the APX21 device in his clinic, and noted the following:
- Good ergonomics 트
- Precision comparable with the RZX on new treatments and re-treatments.
- Good audible signal I
- Should preferably be used on wet canal without exception of liquid
- I Excellent visibility on the screen
In-Vitro and In-Vivo studies were carried out to evaluate the performance of the new root-APX21. As part of the study, accuracy and stability of the APX21 were compared to those of Morita's Root ZX.
The APX21 proved to be unconditionally stable, while the RZX exhibited inherent instabilities at certain conditions.
The two devices achieved high rate of accuracy, falling well within the acceptable accuracy range criterion of ±0.5. Nevertheless, accuracy rates achieved with the APX21 In-Vivo were higher relative to the Root ZX, especially when unstable readings were taken into account and/or accuracy range criterion was narrowed down to ±0.2.
All system components that come in contact with the treated patient are biocompatible and autoclaveable.
System was Electrical safety and EMC tested per IEC 60601.
Conclusion
Techdent's APX21, 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 APX21 has the same intended use and fundamental scientific technology as its predicate device - Morita's Root ZX (K921979).
The APX21 was extensively tested - both Bench and Clinically - against its predicate, and was found to be substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2008
Techdent Technologies Limited C/O Mr. Benny Arazy Chief Executive Officer and President Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187 ISRAEL
Rc: K073185
Trade/Device Name: APX21 - Electronic Apex Locator Regulation Number: 21 CFR 872.3630 Regulation Name: Unclassified Regulatory Class: None Product Code: LQY Dated: January 30, 2008 Received: February 11, 2008
Dear Mr. Arazy:
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.
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Page 2 - Mr. Arazy
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 l'ederal 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fa. Snow Quong
Chiu Lin, Ph.D.
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
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SECTION 4: Indications for Use
510(k) Number:
Device Name: APX21 - Electronic Apex Locator
Intended Use:
The APX21 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 APX21 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 APX21 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 (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
6073/85
8738
N/A