(66 days)
The Veraviewepocs is an extraoral source X-ray unit that it used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation.
The Veraviewepocs includes a base, a support column, a patient frame mounted to the support column, a C-arm assembly, and a control box. The unit weighs approximately 184 kilograms and has dimensions of 235.5 cm (height), 100 cm (width), and 122 cm (depth). The patient frame and the C-arm assembly are mounted to the support column. The control box, which includes operational lights and an emission button, is typically placed in a separate room from the rest of the system. The patient frame includes patient handles for the patient to hold, a chin rest on which to position the patient's head, and temple stabilizers to position the patient's head during the X-ray session. A lip and nose positioner can optionally be used with the chin rest. The C-arm assembly includes a cassette holder to hold an X-ray cassette on one side of the patient's head, an X-ray head on the other side of the patient's head, a Frankfurt plane light beam, a Frankfurt plane light beam knob, a temple stabilizer knob, an image layer light beam, and a control panel. The Frankfurt plane beam, Frankfurt light beam knob, the temple stabilizer knob, and the image layer light beam are used to position the patient's head for optimal X-ray performance. The control panel also is used to position the patient with respect to the Carm. With the patient positioned within the C-arm, the operator leaves the room and uses the emission button mounted to the control box to expose an X-ray. Pressing the emission button causes the C-arm to rotate around the patient's head while the X-ray head emits X-rays in the direction of the X-ray cassette, which contains an intensifying screen and X-ray film, to expose the X-ray film.
The Veraviewepocs can be used to take standard panoramic images, pediatric panoramic images, maxillary sinus panoramic images, and TMJ quadruple images (i.e., four views of the TMJ, one each of both sides of the mouth with the mouth open and closed). A different button on the control panel is used to set the parameters for that type of image. The standard panoramic images can be magnified at 1.3X or 1.7X. The pediatric panoramic image has a magnification of 1.3X, reduces the X-ray image emission by 10 to 15 percent relative to the standard panoramic image, and reduces the angle of the C-arm's rotation to better coincide with the smaller size of a child's dental arch. The maxillary sinus panoramic image has a magnification of 1.5X and is used to examine the maxillary sinus and facial injuries. The TMJ quadruple image has a magnification of 1.3X and causes the C-arm to rotate twice - once with the patient's mouth open and once with the patient's mouth closed.
The Veraviewepocs operates in either a high speed radiographic mode or a normal speed radiographic mode, and with automatic or manual exposure. Use in the high speed radiographic mode causes the C-arm to rotate approximately twice as fast as many conventional extraoral X-ray source units, such as the Veraviewepocs, while still using conventional exposure rate factors, such as tube voltage and tube current (amperage). The benefit of operating in this mode is that the radiation exposure time is reduced by approximately 50% and the amount of ionizing radiation received by the image receptor, is approximately 50% less than during operation in the normal mode of operation. This mode is made possible by using a conventional high sensitivity intensifying screen, and results in the image density remaining the same as in conventional or normal modes. The intensifying screen fluoresces in response to the X-ray radiation. A high sensitivity intensifying screen merely fluoresces more, relative to a low sensitivity intensifying screen, when exposed to the same level of X-ray radiation. The X-ray film is exposed to the fluorescence from the intensifying screen to impart the image on the film.
One example of a screen and film combination is a combination of a conventional Fuji Photo Film Grenex HR-12 Intensifying Screen with conventional Kodak T-Mat G film. The Veraviewepocs also can be operated in the normal speed mode and use a normal speed radiographic screens, such as the Kodak Lanex MEDIUM.
When used in the automatic exposure mode, the X-rays passing through the patient are detected by a sensor. The device uses the signal received to control the tube voltage and current with respect to the speed of the film's movement. The objective of operating in this mode is to ensure a high quality image with a consistent level of density for patients varying in size from small children to large adults.
The provided text is a 510(k) summary for the J. Morita Manufacturing Corporation's Veraviewepocs Panoramic X-ray Unit. It details the device's technical characteristics, intended use, and its substantial equivalence to a predicate device. However, it does not contain information about studies conducted to establish acceptance criteria or device performance using specific metrics.
The document is a premarket notification for a medical device (510(k)), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria, sample sizes, expert adjudication, or MRMC studies that would be typical for proving clinical effectiveness or diagnostic accuracy.
Therefore, I cannot populate the requested table or answer most of the questions because the provided text does not contain that information.
Here's what can be inferred or directly stated from the text:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document. The 510(k) focuses on demonstrating "substantial equivalence" based on similar intended use and technological characteristics, as well as an assessment that differences do not raise new issues of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The document does not describe a clinical test set or data from human subjects for performance evaluation. The substantial equivalence argument is based on technical specifications and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No test set requiring ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set or adjudication process is mentioned.
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/Not provided. This is an X-ray unit, not an AI-powered diagnostic tool. No MRMC studies or AI involvement are discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware device for image acquisition, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth data is discussed as no performance study is detailed.
8. The sample size for the training set
- Not applicable/Not provided. There is no mention of an algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training set is described.
Summary of what the document does provide regarding substantial equivalence:
- Predicate Device: Instrumentarium Corporation Imaging Division's Orthopantomograph OP100 ("OP100").
- Argument for Substantial Equivalence:
- Same general intended use: "dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation."
- Similar technological characteristics and operating principles.
- Principal Differences noted (and deemed not to raise new safety/effectiveness issues):
- Availability of a high-speed radiographic mode on the Veraviewepocs (reducing exposure time by ~50%).
- Preprogrammed exposure control on OP100 (not on Veraviewepocs).
- Differences in nominal magnifications.
- TMJ postero-anterior mode on OP100 (not on Veraviewepocs).
The FDA's decision to clear the device (K013955) is based on the finding of "substantial equivalence" to the predicate device, meaning it has determined that the device is as safe and effective as a legally marketed device. This is a regulatory pathway for devices that are not novel and do not raise new questions of safety or effectiveness.
§ 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.