(83 days)
J.Morita USA, Inc.'s Versaview Panoramic-Cephalometric Dental X-Ray System ("Panoramic/Cephalometric System") is intended to take panoramic and cephalometric dental x-rays including anteriorposterior, posterior-anterior, and submentovortex views.
To take panoramic and cephalometric dental x-rays including anterior-posterior, posterior-anterior and submentovortex views.
The modified device consists of a x-ray control unit, x-ray upright assembly, x-ray head, collimator, and cephalometer. The upright assembly and cephalometer have a patient positioning assembly which is used to position and hold the patient's head during a dental x-ray. The patient positioning assembly on the upright assembly consists of a forehead stabilizer, zygoma stabilizer, bite block, bite block cover, and chin rest. The patient positioning assembly on the cephalometer consists of forehead stabilizer, rearhead stabilizer, and ear rod.
Based on the provided 510(k) summary for the J.Morita USA, Inc. Versaview Panoramic/Cephalometric Dental X-Ray System, here's an analysis regarding acceptance criteria and the study proving it:
Summary of Device Acceptance:
The provided document is a 510(k) summary, which is a submission to the FDA for demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on showing that the new device has the same intended use, technological characteristics, and safety/effectiveness as existing devices, rather than establishing entirely new performance criteria through clinical trials. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study with specific metrics like sensitivity/specificity for a diagnostic AI device is not applicable here.
Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices. The "study" proving this is a comparison of technological characteristics and intended use between the new device and the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Comparison to Predicate Devices) |
|---|---|
| Intended Use Equivalence: The new device must have the same intended use as legally marketed predicate devices. | Intended Use: "To take panoramic and cephalometric dental x-rays including anterior-posterior, posterior-anterior, and submentovortex views." This is identical to the intended use of the predicate devices. |
| Technological Characteristics Equivalence: The new device must have technological characteristics (e.g., design, materials, energy source, etc.) that are either identical to or as safe and effective as those of the predicate devices. Differences must not raise new questions of safety or effectiveness. | Similar Technological Characteristics: - Similar X-ray outputs - Similar focal spot sizes - Similar total filtration - Similar maximum tube voltage and current - Same patient contacting materials (compared to Versaview Panoramic System) Description of new device components and operation: - X-ray control unit, x-ray upright assembly, x-ray head, collimator, and cephalometer. - Patient positioning assemblies (forehead stabilizer, zygoma stabilizer, bite block, chin rest for panoramic; forehead stabilizer, rearhead stabilizer, ear rod for cephalometric). - Dentist positions patient, loads film cassette, adjusts voltage/amperage/time, presses emission button. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This submission is for a traditional X-ray imaging device, not an AI/software device that requires a "test set" of images or patient data to evaluate algorithmic performance. The evaluation is based on engineering specifications and comparison to existing hardware.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. See point 2. Ground truth for an X-ray machine itself isn't established in this manner. The "ground truth" here is that the machine produces X-rays according to its specifications, which is verified through engineering tests and comparison to predicate devices, not by expert review of output images for diagnostic accuracy in a study.
4. Adjudication Method for the Test Set
- Not Applicable. See point 2.
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 Applicable. This device is an X-ray machine, not an AI software. No AI component is described or evaluated in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an X-ray machine, not an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Performance Data of Predicate Devices: The "ground truth" for this 510(k) submission is derived from the established safety and effectiveness of the legally marketed predicate devices and the engineering specifications of the new device itself. Compliance with recognized standards for X-ray equipment (though not explicitly listed in this excerpt, often a part of the full submission) and internal testing to ensure the device meets its design specifications would form the basis.
8. The Sample Size for the Training Set
- Not Applicable. As an X-ray machine, there is no "training set" in the context of an AI algorithm. Its design and manufacturing are based on established engineering principles and performance standards for medical devices.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
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J.Morita USA, Inc. Versaview Panoramic/Cephalometric Dental X-Ray System 510 (k) Summary
Submitter's Name, Address, and Telephone Number
J.Morita USA, Inc. JAN 20 1998 14712 Bentley Circle Tustin, CA 92680 Telephone: Facsimile:
Contact Person
Terry G. Mahn Fish & Richardson PC Suite 500 601 Thirteenth St., NW Washington, DC 20005 Telephone : (202) 783-5070 (202) 783-2331 Facsimile:
as Regulatory Counsel to J.Morita USA, Inc.
Date Prepared
October 21, 1997
Name of Device
Versaview Panoramic-Cephalometric Dental X-Ray System
Classification Name
Extraoral Dental X-Ray Device with Cephalometer
Common Name
Panoramic-Cephalometric Dental X-Ray System
Predicate Devices
Kaycor International's Panoura ULTRA Pan/Ceph X-Ray Unit Kaycor International's Panoura-10C Pan/Ceph X-Ray Unit J.Morita USA, Inc.'s Versaview Panoramic Dental X-Ray System
Intended Use
J.Morita USA, Inc.'s Versaview Panoramic-Cephalometric Dental X-Ray System ("Panoramic/Cephalometric System") is intended to take panoramic and cephalometric dental x-rays including anteriorposterior, posterior-anterior, and submentovortex views.
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Substantial Equivalence
The Panoramic/Cephalometric System is a modification of J.Morita USA, Inc.'s Versaview Panoramic Dental X-Ray System. The modified device consists of a x-ray control unit, x-ray upright assembly, x-ray head, collimator, and cephalometer. The upright assembly and cephalometer have a patient positioning assembly which is used to position and hold the patient's head during a dental x-ray. The patient positioning assembly on the upright assembly consists of a forehead stabilizer, zygoma stabilizer, bite block, bite block cover, and chin rest. The patient positioning assembly on the cephalometer consists of forehead stabilizer, rearhead stabilizer, and ear rod.
To take a x-ray, the dentist positions the patient in one of the patient positioning assemblies and loads the film cassette on the cassette holder. If taking panoramic x-rays, the dentist adjusts the exposure voltage and amperage. If taking a cephalometric xray, the dentist adjusts the exposure voltage and time. The exposure amperage in cephalometric x-ray mode is automatically set at 10 milliamps. The dentist presses the emission button on the control unit's handswitch to take the x-ray. After the exposure is complete, the patient can move away from the x-ray.
The Panoramic/Cephalometric System is substantially equivalent to the predicate devices because they have the same intended use, principles of operation and technological characteristics. For instance, the devices have similar x-ray outputs, focal spot sizes, total filtration, and maximum tube voltage and current. In addition, the Panoramic/Cephalometric System and the Panoramic System have the same patient contacting materials.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1998
J. Morita USA. Inc. c/o Fish & Richardson 601 13th Street, N.W. Suite 500 North Washington, DC 20005 Attn: Terry G. Mahn
Re: K974077
Versaview Panoramic-Cephalometric Dental X-Ray System Dated: October 28, 1997 Received: October 29, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Mahn:
We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 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 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,
h. William Yu.
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):
Versaview Panoramic-Cephalometric Dental X-Ray Device Name: System
Indications For Use:
To take panoramic and cephalometric dental x-rays including anterior-posterior, posterior-anterior and submentovortex views.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K974077 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 C.F.R. 801.109) |
(Optional Format 1-2-96)
79228.W11
§ 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.