(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.
§ 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.