(198 days)
The SiroEndo is intended for dental root canal length measurement and root canal treatment.
The SiroEndo is an electronic digital control system indicated for endodontic treatment that allows a dentist to locate the anatomical root canal apex and to obtain root canal length measurements. The SiroEndo system is comprised of the central unit mounted via a support arm to a dental unit, micromotor, foot pedal and power supply. The central unit electronically controls the micromotor's rotation speed, rotation direction and torque. A commercially available handpiece is attached to the micromotor. Systems of files are selectable with corresponding preset values for rotation speed and torque that are adjusted according to the entered handpiece reduction ratio. Individual values of rotation speed and torque can be entered and saved. File systems with individual values of rotation speed and torque can be stored in an internal memory or on a SiroEndo memory stick and can be re-called. The SiroEndo incorporates a selectable auto-stop and auto-reverse function triggered when the selected torque has been reached. The SiroEndo offers a selectable apex locator feature that makes the distance between file tip and apex visible. The motor stops, if programmed, when the apex has been reached.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. It primarily focuses on the regulatory submission and determination of substantial equivalence for the Sirona Dental Systems SiroEndo device to a predicate device.
However, based on the information provided, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Expected) | Reported Device Performance |
|---|---|---|
| Electrical Safety | (Not specified in document) | Performance testing was conducted. |
| Electromagnetic Compatibility (EMC) | (Not specified in document) | Performance testing was conducted. |
| Hardware Functions | (Not specified in document) | Validation testing was conducted. |
| Software Functions | (Not specified in document) | Validation testing was conducted. |
| Root Canal Length Measurement Accuracy | (Not specified in document, implied for "dental root canal length measurement" intended use) | Not reported in quantitative terms. The device "makes the distance between file tip and apex visible." |
| Micromotor Control Accuracy (Speed, Torque) | (Not specified in document, implied for "electronic digital control system" and "micromotor's rotation speed, rotation direction and torque") | Not reported in quantitative terms. |
| Auto-stop/Auto-reverse Functionality | (Not specified in document) | The device "incorporates a selectable auto-stop and auto-reverse function triggered when the selected torque has been reached." The motor "stops, if programmed, when the apex has been reached." |
Missing Information: The document states that "Performance testing to validate the safety and effectiveness of the SiroEndo included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions." However, it does not specify the acceptance criteria (e.g., specific thresholds for accuracy, tolerance levels for electrical parameters) for these tests, nor does it provide the results of these tests in a quantitative or qualitative manner beyond stating that they were conducted.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned.
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)
Not mentioned in the document. The document describes internal performance testing, but not a study involving human experts to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned, as there is no description of a study involving a test set with human adjudication.
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 mentioned or implied. This device is described as an electronic digital control system for endodontic treatment including an apex locator, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "validation testing of both hardware and software functions" and "The SiroEndo offers a selectable apex locator feature that makes the distance between file tip and apex visible. The motor stops, if programmed, when the apex has been reached." This implies standalone testing of these functionalities, but no specific study details (like sample size, methodology, or quantitative results) are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for any of the performance tests. For the apex locator function, the ground truth would inherently relate to the actual anatomical apex location, likely determined by methods like direct visualization, radiographic comparison, or histological analysis during development/validation, but this is not detailed in the document.
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning or AI model that typically requires a distinct training set. The device's functionality is based on electronic measurements and control, not learned patterns from data.
9. How the ground truth for the training set was established
Not applicable for the same reason as #8.
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MAR 3 1 2006
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510(k) Summary for Sirona Dental Systems SiroEndo
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone:
Date Prepared: November 14, 2005
2. DEVICE NAME
| Proprietary Name: | SiroEndo |
|---|---|
| Common/Usual Name: | Dental root canal measurement and treatment device |
| Classification Names: | Dental Handpiece and Accessories and Root ApexLocator |
3. PREDICATE DEVICE
Morita DENTAPORT ZX (K031204)
4. INTENDED USE
The SiroEndo is intended for dental root canal length measurement and root canal treatment.
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ട. DEVICE DESCRIPTION
The SiroEndo is an electronic digital control system indicated for endodontic treatment that allows a dentist to locate the anatomical root canal apex and to obtain root canal length measurements. The SiroEndo system is comprised of the central unit mounted via a support arm to a dental unit, micromotor, foot pedal and power supply. The central unit electronically controls the micromotor's rotation speed, rotation direction and torque. A commercially available handpiece is attached to the micromotor.
Systems of files are selectable with corresponding preset values for rotation speed and torque that are adjusted according to the entered handpiece reduction ratio. Individual values of rotation speed and torque can be entered and saved. File systems with individual values of rotation speed and torque can be stored in an internal memory or on a SiroEndo memory stick and can be re-called. The SiroEndo incorporates a selectable auto-stop and auto-reverse function triggered when the selected torque has been reached.
The SiroEndo offers a selectable apex locator feature that makes the distance between file tip and apex visible. The motor stops, if programmed, when the apex has been reached.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The SiroEndo is substantially equivalent to the Morita DENTAPORT ZX (K031204) based on equivalence of the intended use, similar features and technical characteristics. Performance testing to validate the safety and effectiveness of the SiroEndo included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
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Public Health Service
MAR 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems GMBH C/O Ms. Mary McNamara-Cullinane Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760-4153
Re: K052515 Trade/Device Name: SiroEndo Regulation Number: 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: I Product Code: EKX Dated: March 16, 2006 Received: March 17, 2006
Dear Ms. McNamara-Cullinane:
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 (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 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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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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susan Panne
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): 052515
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The SiroEndo is intended for dental root canal length measurement and root canal treatment.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sreen Kumar
1 2017 239, General H. 10 Denisle
November 14, 2005
§ 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.