(64 days)
The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.
The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are filmless systems intended for digital intraoral, extraoral and cephalometric radiography using a phosphor storage screen. They enable the dentist to scan or import images for display, review or storage in a database. They consist of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a userprovided personal computer.
This 510(k) summary (K990049) for the CD-Dent Digital-Imaging Device for Dental X-Ray Systems does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The provided document is primarily an administrative summary for a 510(k) submission, confirming the device's substantial equivalence to predicate devices.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The summary focuses on product description, intended use, and a list of predicate devices.
However, I can extract the available information and state where information is missing:
Response based on K990049 Summary:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The 510(k) summary does not list specific acceptance criteria or provide a table of reported device performance against such criteria. The FDA's decision of substantial equivalence in this context typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, performance testing, and comparison of technical characteristics, rather than explicitly stated acceptance criteria and a detailed performance table in the summary.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. The 510(k) does not describe a specific clinical or performance test set, its sample size, or the provenance of any data used for such a test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not available in the provided document. No information is given regarding ground truth establishment, experts, or their qualifications.
4. Adjudication Method for the Test Set
Not available in the provided document. No mention of an adjudication method is made.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available in the provided document. The summary does not indicate that an MRMC comparative effectiveness study was performed, nor does it discuss human reader improvement with or without AI assistance. The device is described as an "Accessory to Electrostatic X-Ray imaging system," which implies it is for image acquisition and display, not an AI diagnostic tool in the modern sense.
6. Standalone (Algorithm Only) Performance Study
Partially available/Inferable, but no specific study details. The core of a 510(k) submission for an imaging device often includes technical performance data to demonstrate that the device produces images of comparable quality to predicate devices. While a formal "standalone" algorithm performance study in the context of AI isn't detailed, the substantial equivalence determination implies that the imaging system itself (the "digitizer" and "software for displaying, enhancing, and storing dental radiographs") has met performance expectations. However, no specific study, metrics, or results are provided in this summary.
7. Type of Ground Truth Used
Not available in the provided document. The document does not specify any type of ground truth used for performance evaluation (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set
Not applicable/Not available in the provided document. Given the device is an "Accessory to Electrostatic X-Ray imaging system" and was approved in 1999, it is highly unlikely to involve machine learning or "AI" in the contemporary sense, which would require a training set. Therefore, there's no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available in the provided document. As there is no indication of a training set, this information is not provided.
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510(k) Summary
for
CD-Dent Digital-Imaging Device for Dental X-Ray Systems
DATE SUMMARY PREPARED 1.
January 4, 1999
SUBMITTER'S NAME AND ADDRESS 2.
Digident Ltd. Yoqneam Star Bldg. Yoqneam P.O. Box 465 Nesher 36603 Israel
CONTACT PERSON 3.
Mr. Betzalel Halevi 011 972 4 959 1331 Telephone: 011 972 4 959 1262 Facsimile:
DEVICE NAME 4.
| Trade/Proprietary Name: | CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000, and 2000 |
|---|---|
| Common Name: | Accessory to Electrostatic X-Ray imaging system (Dental) |
| Classification Name: | Accessory to Electrostatic X-Ray imaging system |
ડ. PREDICATE DEVICES
The legally marketed devices to which equivalence is being claimed are:
- ScanARay Computerized X-Ray System marketed by AFP Imaging . (K974619)
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DEVICE DESCRIPTION 6.
The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are filmless systems intended for digital intraoral, extraoral and cephalometric radiography using a phosphor storage screen. They enable the dentist to scan or import images for display, review or storage in a database. They consist of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a userprovided personal computer.
INTENDED USE 7.
The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and appears to be part of a document or header. The words are capitalized and evenly spaced.
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:
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Digident, LTD c/o Mary M. McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants. Inc. 49 Plain Street North Attleboro. MA 02760
.. Re: K990049 CD-Dent Digital-Imaging Devices for : ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ Dental X-Ray Systems Dated: January 6, 1999 Received: January 7, 1999 : 21 CFR 872.1800/Procode: 90 MUH
Dear Ms. McNamara-Cullinane:
MAR 1 2 1999
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 dass 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requiration may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The CD-Dent Digital-Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic intraoral and extraoral images
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
CONFIDENTIAL Page v
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-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 outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.