(99 days)
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."
| Acceptance Criteria Category | Specific Metric/Standard | Predicate Device Performance (Implicitly Accepted) | Veraviewepocs X550 Performance (Stated or Implied) |
|---|---|---|---|
| Indications for Use | Identical to predicate | Used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM joints and skull including the ENT and dento maxillofacial areas. | Identical. |
| Target Population | Identical to predicate | Patients requiring dental radiographic examination. | Identical. |
| Performance (Imaging) | International standards | Complies with international standards for both 2D and 3D dental X-ray. | Complies with international standards. |
| Safety - Electrical | International standards | Complies with international electrical safety standards. | Similar to predicate (implicitly compliant with international standards). |
| Safety - Radiation | International standards | Complies with international radiation safety standards. | Identical to predicate (implicitly compliant with international standards). |
| Safety - Mechanical | Industry standards | Complies with mechanical safety standards. | Similar to predicate (implicitly compliant). |
| Biocompatibility | N/A | N/A - Not a patient-contacting device in a manner requiring specific biocompatibility testing. | Similar (implies compliance). |
| Sterility | N/A | N/A - Non-sterile device. | Similar (implies non-sterile). |
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.
§ 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.