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The Veraviewepocs is an extraoral source x ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM joints and skull including the ENT and dento maxillofacial areas, by exposing an X ray image receptor to ionizing radiation. The device uses cone shaped x ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.

The device is to be operated and used by dentists and other legally qualified professionals.

Veraviewepocs ( Model X550) is extraoral source Dental Panoramic X-ray unit with a affequency switching mode x-ray generator. In addition to panoramic exposure, the an also take scano-grams. Also cephalometric device is available that uses the cramic x-ray source.

ther more a three dimensional Cone Beam Computed Tomography (CBCT) is also which uses cone shaped x-ray beam projected onto a flat panel detector.

e main body of X550 includes a base, support column, lift, patient frame, movement and arm, and control box. The main body weighs approximately 184 kilograms and mensions of 235.5cm (height), 102 cm (width), and 133 cm (depth).

movement arm, with a X-ray sensor unit on one side of the patient's head and an thehead on the other hand, is rotated 180 degrees as an arm combined on movement The movement unit with a patient frame, mounted to the lift, moves up and down sally along support column.

of the main body is performed by Control Panel and Control Box. Control 1) selects exposure program, 2) raises up or lower down the lift, 3) positioning ON and OFF, 4) has ready key.

ontrol Box equips hand switch, emission button, emission light, ready light, main er switch, power light, and key switch.

The provided text is a 510(k) summary for the J. Morita USA Inc.'s Veraviewepocs X550 (later referred to as Veraviewepocs 2D/3D). This submission is for a device that is essentially a slightly modified version of a previously cleared 2D panoramic/cephalometric X-ray unit (Veraviewepochs VE, K#030699) with the addition of a 3D Cone Beam Computed Tomography (CBCT) function, similar to another cleared device (3D Accu-I-tomo, K#052587). The submission claims substantial equivalence to Planmeca Oy's ProMax 3D (K#060328) which also combined 2D and 3D capabilities.

Based on the provided text, the specific details regarding acceptance criteria and a dedicated study to prove precise performance metrics aligned directly with those criteria are not explicitly detailed. The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a new, standalone performance study with specific acceptance criteria.

However, we can infer some aspects and present the available information within the requested structure.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a table of explicit acceptance criteria or specific performance metrics from a new study. Instead, it relies on demonstrating that the new device's characteristics are similar or identical to predicate devices that have already met regulatory requirements. The "performance spec" is stated to be aligned with "International standards."

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not describe a specific test set, its sample size, or data provenance for evaluating the performance of the Veraviewepocs X550 against defined acceptance criteria. The submission relies on a comparison to predicate devices, implying that the performance of the predicate device (ProMax 3D, K060328) serves as the benchmark.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The document does not describe a new study that involved establishing ground truth for a test set by a panel of experts.

4. Adjudication Method for the Test Set

Not applicable. There is no described test set or adjudication process in the provided summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. The document does not mention an MRMC comparative effectiveness study. The submission relies on substantial equivalence to predicate devices, not on a study demonstrating how human readers improve with or without AI assistance. This device is an imaging system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for an X-ray imaging device, not an algorithm. The performance of the imaging system itself is evaluated through compliance with international standards and similarity to predicate devices, rather than an "algorithm only" performance study.

7. The Type of Ground Truth Used

Not explicitly stated in the context of a new study for this device. For the predicate devices, the "ground truth" would have likely been established through clinical validation, expert radiographic interpretation, and potentially pathology or surgical findings to confirm diagnostic accuracy during their original clearances. This submission leverages those prior validations by claiming substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The document describes an X-ray imaging device, not a machine learning algorithm that requires a training set. The software mentioned ("Morita made software") likely refers to image acquisition, processing, and display software, not an AI diagnostic algorithm requiring a training phase for clinical performance.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this is not an AI/ML device that requires a training set and associated ground truth establishment.

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The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.

The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.

The provided text describes the 510(k) summary for the "J. Morita Manufacturing Corporation's Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function". However, this document does not contain specific acceptance criteria, performance data, or details of a study that directly proves the device meets acceptance criteria.

Instead, the document focuses on:

• Substantial Equivalence: It claims substantial equivalence to previously cleared predicate devices based on intended use, principle of operation, and technological characteristics.
• Compliance with Standards: It states that the device was tested and complied with UL2601-1 and IEC 60601-1, and will comply with 21 C.F.R. Subchapter J and successfully passed image quality testing.
• Software Validation: It mentions a software validation report describing development processes, requirements, hazard analysis, and certification of adherence to procedures.
• Biocompatibility: It addresses the use of biocompatible materials.

This 510(k) summary is a regulatory submission demonstrating substantial equivalence, not a detailed study report for meeting specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document implies acceptance criteria are related to compliance with safety standards (UL2601-1, IEC 60601-1, 21 C.F.R. Subchapter J), successful software validation, and image quality testing. However, specific quantitative acceptance criteria (e.g., minimum resolution, SNR, DQE values, tolerance for geometric distortion) are not provided.
• Reported Device Performance: The document states the device "complied with the applicable requirements" for safety standards and "passed the image quality testing." No specific performance metrics or values are reported.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not provided. The document states "The modified Veraviewepocs was tested" and "passed the image quality testing," but gives no details about the sample size (e.g., number of images, number of patients, number of components tested) or the provenance of any data.

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 provided. The document does not mention the use of experts for establishing ground truth, as it is primarily focused on technical compliance and substantial equivalence rather than diagnostic performance evaluation by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not provided. This information is typically relevant for studies involving human interpretation and consensus, which is not described here.

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

• No, an MRMC comparative effectiveness study was not done or reported. This device is an X-ray unit, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Irrelevant/Not applicable. This device is an imaging hardware unit, not a standalone algorithm. The software mentioned is for controlling the device and processing the images, not for automated diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not provided/Implicit through compliance standards. For "image quality testing," the ground truth would likely be defined by objective metrics and technical specifications (e.g., MTF, spatial resolution, contrast-to-noise ratio measured against phantoms or reference images) rather than medical interpretations like expert consensus or pathology. No details are given.

8. The sample size for the training set

• Not applicable. This device is a hardware X-ray unit with associated operational software, not a machine learning model that requires a "training set" in the conventional sense. The "software validation" refers to verifying that the software meets its specified requirements and functions correctly, not to training an AI model.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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The Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability that is the subject of this 510(k) is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.

The Veraviewepocs Panoramic X-ray Unit is an FDA-cleared 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 (K#013955). The modified Veraviewepocs covered by this submission simply adds a cephalometric capability to the existing device. In addition to manual settings, the modified Veraviewepocs also has an "auto exposure" feature in the cephalometric mode. Exposure time is automatically adjusted depending on the patient's size, and the device is set at 80 kV and 10mA. A sensor behind the cephalometric cassette measures the amount of x- radiation, and the exposure is terminated once the accumulated x-radiation reaches a certain level.

The provided text describes a 510(k) summary for the J. Morita Manufacturing Corporation's Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability. However, it does not contain specific acceptance criteria or a dedicated study section detailing performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to the device's diagnostic performance.

The document focuses on:

• Substantial Equivalence: Comparing the modified Veraviewepocs (with cephalometric capability) to predicate devices (Instrumentarium Corporation Imaging Division's Orthopantomograph OP100 and ORTHOCEPH OC 100).
• Technological Characteristics: Describing the added cephalometric feature and its "auto exposure" functionality.
• Safety and Compliance: Stating that the device complies with electrical safety standards (UL2601-1, IEC 60601-1), software validation, and biocompatibility for materials.
• Intended Use: Broadly for dental radiographic examination and diagnosis.

Therefore, I cannot populate the requested tables and information regarding acceptance criteria, device performance, study details, or ground truth as this information is not present in the provided text. The document primarily attests to regulatory compliance and substantial equivalence rather than a detailed clinical performance study.

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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.

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