(8 days)
The ApexNRG XFR is intended for the measurement of the length of the root canal for purposes of performing root canals and related dental procedures, for use by a trained professional in general dentistry.
The ApexNRG XFR is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.
The ApexNRG XFR is a dental apex locator which has the ability to measure the depth of the root canal by electronic means.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report to prove the device meets these criteria. The document is a 510(k) summary for a medical device (ApexNRG XFR Apex Locator), which primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a full performance study with acceptance criteria.
However, based on the limited information, here's what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of Root Canal Length Measurement (Primary function of an apex locator) | "finer resolution in terms of its LED display" - This implies an improvement in the precision of the output, which indirectly suggests better accuracy or at least better representation of the measurement. |
| Safety and Efficacy (General) | Not explicitly stated with specific metrics. The document states "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns." This indicates that some form of testing was conducted to ensure the modifications did not negatively impact safety or efficacy compared to the predicate. |
| Predicate Equivalence | The device is deemed "substantially equivalent" to the predicate device (MedicNRG Electronic Apex Locator, K032743) regarding technology and intended use. This means its performance is considered comparable to a device already on the market. |
Missing Information for a complete table: Specific quantitative metrics for accuracy (e.g., within +/- 0.5mm of the actual apex), precision, reliability, or clinical effectiveness. The current document is a summary and does not delve into these specifics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The manufacturer is MedicNRG, Ltd. in Israel, but the location where the testing was conducted or the origin of the data is not mentioned.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Not mentioned. This type of study is more common for diagnostic imaging devices where AI assists human readers. An apex locator is a direct measurement tool, so an MRMC study in the traditional sense is unlikely to be applicable for evaluating its primary function.
- Effect size of human readers with AI vs without AI assistance: Not applicable based on the device type and lack of mention.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Was a standalone study done? The device itself is a standalone electronic apex locator, meaning its performance is inherently standalone in generating the root canal length measurement. It is not an AI algorithm that assists a human; it performs the measurement directly. The statement "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns" implies that the standalone performance of the device was evaluated. However, specific details of this evaluation (e.g., test setup, methodology) are not provided.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified. For an apex locator, ground truth would typically be established by direct visual measurement (e.g., using a microscope, direct measurement on extracted teeth, or through surgical/histological confirmation in animal or cadaver studies).
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is an electronic measurement tool, not an AI/machine learning algorithm that requires a training set in the conventional sense. It's based on electrical impedance principles.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: Not applicable, as there's no training set for this type of device.
Summary of what the document does state regarding performance/testing:
- The primary differences from the predicate device are "finer resolution in terms of its LED display and the electrode connections has been changed."
- "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns." This is the only direct reference to testing results influencing the safety and efficacy claim. It suggests that some form of internal testing was conducted to confirm the changes did not negatively impact the device's performance or safety compared to the predicate. This testing would have implicitly involved checking the core functionality and accuracy.
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510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) Submitter Address: | George J. HattubMedicSense, USA291 Hillside AvenueSomerset, MA 02726www.medicsense.com |
|---|---|
| 1. (b) Manufacturer Address: | MedicNRG, Ltd.PO Box 338, MP Gordon ValleyKibbutz Afikim, Israel 15148 |
| Mfg. Phone: | 972-4-675-4217 |
| Contact Person: | Michal Zach, QA Manager |
| Date: | December 20, 2006 |
| JAN - 3 2007 | |
| 2. Device & Classification Name: | Locator, Root, Apex, Class 2, Product Code LQY, unclassifiedApexNRG XFR (Apex Locator) |
| 3. Predicate Device: | MedicNRG Electronic Apex Locator (K032743) |
| 4. Description: | The ApexNRG XFR is a dental apex locator which has the ability tomeasure the depth of the root canal by electronic means. |
| 5. Intended Use: | The ApexNRG XFR is intended for the measurement of the length of theroot canal for purposes of performing root canals and related dentalprocedures, for use by a trained professional in general dentistry. |
| 6. Comparison of Technological Characteristics: | With respect to technology and intended use, the Modified ApexNRG XFR(Apex Locator) is substantially equivalent to its predicate device which is theOriginal MedicNRG Electronic Apex Locator. The primary differences arethat the modified device provides finer resolution in terms of its LED displayand the electrode connections has been changed. Based upon the testingresults, MedicNRG believes these differences do not raise additional safetyof efficacy concerns. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MedicNRG, Limited C/O Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
JAN - 9 2007
Re: K063843
Trade/Device Name: ApexNRG XFR (Apex Locator) Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LQY Dated: December 20, 2006 Received: December 26, 2006
Dear Mr. Hattub:
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. Hattub
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); 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 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.
Sosen Quape
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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Indications for Use
510(k) Number (if known):
Device Name: ApexNRG XFR (Apex Locator)
Indications For Use: The ApexNRG XFR is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Ronn
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tions of Anesthesiology, General Hospital,
ction Control, Dental Devices
KC063893
)
N/A