(76 days)
The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.
The ScanARay Advanced Computerized X-Ray System is a filmless system intended for digital intraoral and extraoral radiography using a phosphor storage screen. It enables the dentist to scan or import images for display, review or storage in a database. It consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a user-provided personal computer.
Unfortunately, the provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The document is a 510(k) summary for the ScanARay Advanced Computerized X-Ray System, which focuses on establishing substantial equivalence to predicate devices for regulatory clearance.
It describes the device, its intended use, and lists predicate devices, but it does not include the following information requested:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory equivalence, not specific performance metrics against defined criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device predates widespread AI integration in medical imaging, and the document itself makes no mention of AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and again, consistent with the device's era and description, it's unlikely a standalone algorithm performance study as understood today would have been conducted or relevant.
- The type of ground truth used: Not explicitly stated. For an X-ray system, the ground truth would typically be the clinical assessment by a dentist from the radiographic images, but the specifics of how this was established for any performance testing are absent.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion:
The provided document is a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence to existing devices for market approval. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in clinical validation studies for a new device's specific claims or AI components.
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FEB 2 5 1998
510(k) Summary for ScanARay Advanced Computerized X-Ray System
- December 10, 1997 DATE SUMMARY PREPARED: 1.
- SUBMITTER'S NAME AND ADDRESS 2.
AFP Imaging 250 Clearbrook Road Elmsford, NY 10523
- CONTACT PERSON 3.
Mr. David Vozick
| Telephone: | (914) 592-6100 |
|---|---|
| Facsimile: | (914) 592-6148 |
4. DEVICE NAME
ﺑﻪ ﻭ ScanARay/CD-Dent Advanced Computerized X-Ray Trade/Proprietary Name: System Electrostatic X-Ray imaging system (Dental) Common Name: Classification Name: Electrostatic X-Ray imaging system
5. PREDICATE DEVICES
The legally marketed devices to which equivalence is being claimed are:
DEVICE DESCRIPTION 6.
The ScanARay Advanced Computerized X-Ray System is a filmless system intended for digital intraoral and extraoral radiography using a phosphor storage
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screen. It enables the dentist to scan or import images for display, review or It consists of reusable phosphor storage screens for storage in a database. recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a user-provided personal computer.
7. INTENDED USE
The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1998
Mary M. McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re:
K974619 AFP Imaging ScanARay (CD-Dent) Advanced Computerized X-Ray System Dated: December 10, 1997 Received: December 11, 1997 Regulatory class: II 21 CFR 892.1630/Procode: 90 IXK/90 LMA
Dear Ms. McNamara-Cullinane:
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 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). You may, therefore, whice 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 (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 requirement, 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 regulation may result in regulatory 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 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 predication 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 question 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/dsmamain.html/"-------
Sincerely yours.
hồ tiêu Yến
Lillian Yin, Ph.D. 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:
4 :
The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K974619 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR Over-The-Counter Use ______
(Optional Format 1-2-96)
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.