(57 days)
The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.
The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file.
The provided document is a 510(k) premarket notification for the Dentron Sensor. This type of submission is a declaration of substantial equivalence to a predicate device, not typically a full clinical study with detailed performance data against specific acceptance criteria.
Based on the document, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution targets) for the Dentron Sensor. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.
The "Comparison Table" provided in the document outlines technical characteristics of the Dentron Sensor and its predicates. Here's a summary of those technical characteristics, which could be considered "performance" in the context of a 510(k) in comparison to predicates, but not against predefined acceptance criteria for a novel clinical claim.
| Characteristic | Dentron Sensor Performance (Reported) |
|---|---|
| Intraoral Sensor | CCD + fiber optic plate + scintillator |
| Sensor size (active area) | Size 1: 30x20mm, Size 2: 34x24mm |
| Sensor cable connection | Sealed at the factory |
| Theoretical resolution | 10 lp/mm |
| Digitalization / Conversion Resolution | 12 bits (4095 ADU) |
| Connection | Wired, USB to CCU |
| Connection medium | CCU with USB cable |
| Image file format | Greyscale |
| Power supply | Powered through USB connection |
| Sterile product | No |
| File capturing, management and storage | Commercial software (not part of device), e.g., DentalEye 510k #K012439 |
| PC minimum environment | Windows 2000 / XP |
2. Sample size used for the test set and data provenance:
- The document does not report specific sample sizes for a test set in the context of clinical performance evaluation.
- The document refers to mechanical, electrical, and electromagnetic compatibility testing standards (UL 60601-1, EN 60601-1-2, IEC 60601-1-4) with associated test reports (e.g., IMQ S.p.A. Test report nº 27SE00094). These tests typically involve device units, not patient-derived data sets.
- Data provenance is not applicable in the sense of clinical data (e.g., country of origin, retrospective/prospective) because such a study is not described.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. The submission does not describe a clinical study requiring ground truth derived from expert consensus on a test set. The focus is on technical equivalence and compliance with safety standards.
4. Adjudication method for the test set:
- Not applicable. No clinical test set and subsequent adjudication method are described in this 510(k) submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a digital intraoral X-ray sensor, not an AI-powered diagnostic aid. No MRMC study is mentioned or expected for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware (a sensor) for capturing images, not a standalone algorithm.
7. The type of ground truth used:
- For the technical characteristics comparison, the "ground truth" implicitly relies on established specifications and performance of the predicate devices and general industry standards for intraoral imaging. There is no specific clinical "ground truth" (e.g., pathology, outcomes data) reported for this 510(k) submission. Compliance with international safety and electrical standards (UL, EN, IEC) forms part of the "ground truth" for safe operation.
8. The sample size for the training set:
- Not applicable. This device is a hardware sensor; therefore, there is no "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.
In summary:
This 510(k) submission for the Dentron Sensor focuses on demonstrating substantial equivalence to predicate devices based on:
- Similar intended use: Capturing intraoral X-ray images for dental diagnostic purposes.
- Similar technological characteristics: As detailed in the comparison table regarding sensor type, resolution, connection, etc.
- Compliance with recognized voluntary standards: UL 60601-1, EN 60601-1-2, and IEC 60601-1-4 for safety and EMI/EMC.
The phrase "The proposed and predicated devices are substantially equivalent, similar devices that have been used by dentists in the US since 1989 and well accepted" directly addresses how the device meets the regulatory hurdle for market entry, rather than through a traditional clinical study with defined acceptance criteria for diagnostic performance metrics.
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Image /page/0/Picture/1 description: The image shows the logo for Video Digital RF America. The logo is in black and white and features a stylized "Video" with radio waves emanating from the "V". The word "Digital" is stacked vertically to the right of "Video", and "RF America" is below "Digital". The text is pixelated.
ා ව ධිරිස් ලියානයය සිහුස්ල දා 11, පිළිබඳ 200 Ormond Peach, [7] 17 - 1 (1 80-11-2... 120 73 - 14 - 2414 力:"快乐"的一个人 www.videodental.com
PREMARKET SUMMARY (As Required By 21 CFR 807393)
MAY 1 3 2008
Contact person: Claude Berthoin Video Dental Concepts, Inc. 110 East Granada Boulevard Suite 207 Ormond Beach, FL 32176 Phone: 800-323-2690
Alternate contact: Sue Williams
General Information
Proprietary or Trade Name: Dentron Sensor
Common/Usual Name: Dental Image Management System
Classification & Regulation Number: Class II, CCD area image sensor; MUH, MQB; 892.1650
- Reason for Premarket Notification: Product manufactured in Louisiana and is new to the market.
The intended device is similar in intended use, material, safety and effectiveness in similar applications to: CEFLA s.l.r.'s MyRay K061114, Air Technique's Accent K050693, and Julie Alliance's QuickRay DSX 730 K990002.
The device is to be distributed by Dentron Systems, LLC in the United States.
The following voluntary standards are utilized in whole or in part:
UL 60601-1:2003, Medical Electrical Equipment, Part 1: General Requirements for Safety and Canadian deviations -- see IMQ S.p.A. Test report nº 27SE00094 and CSA/UL certificate 231961;
EN 60601-1-2: 2001 Medical Electrical Equipment -- Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Test, See IMQ S.p.A Test report nº 80SF00347/1 and 80SF000347/2; and
IEC 60601-1-4: 2000 Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems, See IMQ S.p.A Test report n° 27SE00094.
The materials in the device are identical to materials used in the identified predicate device.
Comparison of the Dentron Sensor to the legally marketed predicate devices:
Image /page/0/Picture/20 description: The image shows the word "myray" in a bold, sans-serif font. The "m" is stylized with three curved lines underneath it, resembling sound waves or a stylized smile. The rest of the letters, "yray", are in a similar bold font and are connected to the "m". The overall design is simple and modern.
Discovery
Image /page/0/Picture/22 description: The image shows the word "retropan" in a bold, sans-serif font. Above the word is a crescent-shaped design with a textured surface. The text is in black, and the background is white. The overall design appears to be a logo or brand name.
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Image /page/1/Picture/0 description: The image shows the words "Video Detal" in a stylized font. Below the words, it says "RF America". The text is black and white and appears to be a logo or brand name.
110 East Grand a Rouler ard, Suite a Pr Omnonia. Gearth 19 17170 100.325.26 - 1 36. 372 1456 トアイ 386 レビュー 2017
| ComparisonTable | Dentron Senso | MyRay WDS | Accent | QuickRay |
|---|---|---|---|---|
| K# | TBD | K061114 | K050693 | K990002 |
| Intraoral Sensor | CCD + fiber opticplate + scintillator | CCD + fiber opticplate + scintillator | CCD + scintillator | CCD + scintillator |
| Sensor size(active area) | Size 1: 30x20mmSize 2: 34x24mm | Size 1: 20x30mmSize 2: 24x34mm | Size 1: 20x30mmSize 2:27.5x36.08mm | 21.4x34mm |
| Sensor cableconnection | Sealed at thefactory | sealed at thefactory | Sealed at the factory | Sealed at thefactory |
| Theoricalresolution | 10 lp/mm | 25 lp/mm | 22.7 lp/mm | 23.8 lp/mm |
| Digitalization /ConversionResolution | 12 bits (4095 ADU) | 12 bit, 4096 greylevels | 12 bit, 4096 greylevels | 12 bit, 4096 greylevels |
| Connection | Wired, USB to CCU | Wireless, Bluetooth | Wireless, Bluetooth | Wired, USB to CCU |
| Connectionmedium | CCU with USBcable | USB-Bluetoothadapter | USB-Bluetoothadapter | CCU with USBcable |
| Image file format | Greyscale | Greyscale, TWAINcompatible | Greyscale, TWAINcompatible | Greyscale,Proprietary |
| Power supply | Powered throughUSB connection | 3xAA rechargeablebatteries | 4xAA rechargeablebatteries | Power applied toCCU only via 12Vpower adapter |
| Sterile product | NoExistingCommercial | No | No | No |
| File capturing,management andstorage | software (not partof the device).DentalEye 510k#K012439 | Commercialsoftware (not partof the device) | Commercialsoftware (not part ofthe device) | Commercialsoftware (not partof the device)P III 600MHz. |
| PC minimumenvironment | Windows 2000 / XP | P III 800MHz.Windows XP, 256kRAM, 150M HDU,USB2port,1024x768x16millioncolor display | Intel P IV 2.8 GHz,Windows XP pro, 1GRAM, 120G HDU,USB 1.1 port,1024x768x16millioncolor display | Windows 98SE, XP128K RAM, 10GHDU, 2 x USB ports(unspecified).1024x768x16millioncolor display |
- concise summary for any performance testing in the submission ●
- The proposed and predicated devices use similar components and are similar in design, ◆ technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file. The porposed and predicated devices are substantially equivalent, similar devices that have been used by dentists int he US since 1989 and well accepted.
Image /page/1/Picture/6 description: The image shows the word "myray" in a bold, sans-serif font. The "m" has a curved line underneath it, resembling a smile or a wave. The letters are closely spaced together, giving the word a compact appearance. The overall design is simple and modern.
Image /page/1/Picture/7 description: The image shows the word "Discovery" in a bold, sans-serif font. The word is slightly distorted, with some blurring and pixelation. There is some additional text or graphics to the right of the word, but it is difficult to make out any details.
Image /page/1/Picture/8 description: The image shows the word "retropan" in a bold, sans-serif font. Above the word is a curved, crescent-shaped design. The text and design are both in black, contrasting with the white background.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol with three blue figures and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The symbol is on the left side of the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Dentron Systems. LLC % Mr. Claude D. Berthoin President/Owner Video Dental Concepts. Inc. 11 East Granada Boulevard. Suite 207 ORMOND BEACH FL 32176
AUG 2 3 2013
Re: K080738
Trade/Device Name: Dentron Sensor Regulation Number: 21 CFR 872.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP and MQB Dated: March 13. 2008 Received: March 18, 2008
Dear Mr. Berthoin:
This letter corrects our substantially equivalent letter of May 13, 2008.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
Applicant: Video Dental Concepts, Inc.,
510(k) Number (if known): K080738
Device Name: Dentron Sensor
Indication For Use: The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.
Prescription Use _X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 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 Office of Device Evaluation
510(k)
Amy M. Wilson
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.