(65 days)
FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
The FineCube consists of two main elements: (1) The X-Ray generation and acquisition system and (2) the image analysis software. The X-Ray generation/acquisition system creates a cone-shaped x-ray field which is acquired on a flat panel sensor with a resolution of 608 x 616 x 200 um. FineCube is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. FineCube is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects
The provided 510(k) summary for the FineCube Dental CT System (K063622) does not contain detailed information about acceptance criteria and specific studies demonstrating the device meets those criteria. Instead, it focuses on establishing substantial equivalence to predicate devices based on indications for use and specification comparisons.
Here's a breakdown of the available information and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The 510(k) summary only provides a table comparing the specifications of the FineCube with two predicate devices. It doesn't list defined "acceptance criteria" for performance metrics like image quality, diagnostic accuracy, or specific measurements, nor does it present the FineCube's performance against such criteria. The document states "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices," but no specific performance data or statistical analysis is provided to support this claim against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly stated in the document. The document mentions "bench, test laboratory and clinical testing," but does not provide details on the sample sizes used for these tests or the provenance (country of origin, retrospective/prospective) of any clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not available in the provided document. There is no information regarding the establishment of ground truth by experts for any testing conducted.
4. Adjudication Method for the Test Set
Not available in the provided document.
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
Not applicable. The FineCube is an imaging device (cone beam computed tomography) and not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant to this device's submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. It is a medical imaging device.
7. The Type of Ground Truth Used
Not available in the provided document.
8. The Sample Size for the Training Set
Not applicable. As a medical imaging device, the concept of a "training set" in the context of machine learning algorithms is not directly relevant. The device undergoes engineering and performance validation rather than algorithmic training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the machine learning sense for this device.
Summary of what is available and what is missing:
The 510(k) summary for K063622 primarily relies on demonstrating substantial equivalence to predicate devices through a comparison of their indications for use and technical specifications. While it generally asserts that safety and effectiveness were demonstrated through "bench, test laboratory and clinical testing," it lacks the specific details requested regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert involvement, or any data related to AI performance metrics. This level of detail is often not included in the public 510(k) summary and would typically be found in the complete 510(k) submission that is reviewed by the FDA.
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8 2007
FEB
510(k) Summary 510(k) Number
The Yoshida Dental Mfg. Co., Ltd. 1-3-6, Kotobashi, Sumida-Ku Tokyo, JAPAN 130 85164 Tel: 81-3-3631-2165 Fax: 81-3-3633-9427 www.yoshida-net.co.jp Date Prepared: November 30, 2006 R&D Department (テクニカルセンタ) Contact: Hidenori Watanabe(渡辺英憲)
- l . Identification of the Device: Proprietary-Trade Name: FineCube Classification Name: Computed Tomography X-Ray System Product Code 90 JAK Common/Usual Name: Dental CT
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- Indications for Use (intended use) FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists..
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- Description of the Device: The FineCube consists of two main elements: (1) The X-Ray generation and acquisition system and (2) the image analysis software. The X-Ray generation/acquisition system creates a cone-shaped x-ray field which is acquired on a flat panel sensor with a resolution of 608 x 616 x 200 um. FineCube is an X-ray imaging device that constructs a three dimensional model from images taken during a rotational X-ray sequence. FineCube is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects
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- Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.
| Manufacturer | Imaging SciencesInternational Inc.K051980 | J. MoritaManufacturing.Corporation.K030450 | Yoshida Dental |
|---|---|---|---|
| Product Name | DVT SCANNER | 3D Accu-l-tomo XYZSlice View Tomograph | FineCube |
| Manufacturer | Imaging Sciences | J. Morita | Yoshida Dental |
| International Inc. | Manufacturing. | ||
| K051980 | Corporation. | ||
| K030450 | |||
| Indication for use | The DVT Scannerconstructsa three dimensional modelfrom images taken during arotational X-ray sequence.The DVT Scanner isintended to be usedwhenever a dentist, oralsurgeon, or other physicianneeds 3D information ofhigh contrast objects. TheDVT Scanner is optimizedfor imaging of TM Jointstudies, mandible &maxilla for implantplanning, sinuses, themaxillofacial complex,temporal bone, etc. | The 3D Accu-1-tom0 is anx-ray imaging device thatacquires a 360 degreerotational sequence of thehead and neck areas,including the ENT anddentomaxillofacialareas, for use in diagnosticsupport. The deviceaccomplishes thistask by reconstructing athree-dimensional matrixof the examined volumeand producing two-dimensional views of thisvolume, displaying bothtwo- and three dimensionalimages. The device canalso be used forfluoroscopy duringsurgery, mostly for ENTand TMJ applications andmostly with a contrastmedium. The device isoperated and used byphysicians, dentists, and x-ray technologists. | FineCube is an x-raydevice (cone beamcomputed tomography)that acquires a single360 degree rotationalsequence of the headand neck areas,including the ENT anddentomaxillofacial areafor use in diagnosticsupport.The device is operatedand used by physicians,dentists, and x-raytechnologists. |
| Specificationcomparison | Focal spot: 0.6mmTube voltage:60,80,100,120kVTube current: 10,15mAExposure time: 9.6secEmergency stop method:Emergency stop switchInput: 10kVAPower supply: AC200VProjection mode: CTDetector dimension:9.7 / 4.5 inch | Focal spot:0.5mm x 0.5mmTube voltage: 60 ~ 90kVTube current: 1 ~ 10mAExposure time:Under 18secEmergency stop method:Emergency stop switchInput: 2.0kVAPower supply:AC100V , 50/60HzProjection mode:CT, PanoramicDetector dimension:109mm x 111mm | Focal spot:0.2mm×0.2mmTube voltage: 90kVTube current: 4mAExposure time: 19 /37secEmergency stopmethod:Emergency stop switchInput: 1.5kVAPower supply: AC120V, 60HzProjection mode: CTDetector dimension:120mm x 120mmPixel size:200μm×200μmImage matrix size:608 × 616 pixels |
6. Substantial Equivalence Chart
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7. . Conclusion
After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Yoshida Dental that the FineCube Dental CT System is appare and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is centered on the page. There is a logo to the left of the text. The logo is a stylized image of a human figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
The Yoshida Dental Mfg., Co., Ltd. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
8 2007
Re: K063622
Trade/Device Name: FineCube Dental CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: December 1, 2006 Received: December 20, 2006
Dear Mr. Kamm:
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 (Premarket Approval), 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.
Image /page/2/Picture/9 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a stylized font. The word "Centennial" is below the letters. There are three stars below the word "Centennial."
Protecting and Promoting Public Health
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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: regirstration 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 sectoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-0150,
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 10(x) marketed predicate device results in a classification for your device and thus, perceits 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K063/22
Device Name: FineCube Dental CT System
Indications For Use:
FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
Prescription Use X AND/OR
(Part 21 CFR 801 Subpart D)
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)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.