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510(k) Data Aggregation
(50 days)
The Veraview IC 5 (XDP1) 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 Veraview IC5 Model XDP1( hercinafter XDP1) is an extragral source dental panoramic x-ray system intended to produce x-rays for dental radiographic examination and diagnosis of disease of the teeth, jaw and oral structure. The XDP Ican be used to take standard panoramic images, Pedodontic panoramic images, and TMJ quadruple images. This XDP1 is a device modified from the X550P-D-UL which is one of Veraview epocs Model VE ( K#030699) of J.MORITA MFG. CORP. Both XDP1and X550P-D-UL are dental panoramic device, XDP1 is provided with automatic exposure control by CCD sensor while the latter is incapable of such automatic exposure control. Except automatic exposure control, the main hardware is used unchanged in the same way as the previous, and the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device, so that the XDP1 is substantially equivalent to Veraviewepocs Model VE ( K#030699).
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K053220 for Veraview IC 5 XDP1) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed performance studies for the new device.
Therefore, no explicit acceptance criteria or detailed performance metrics are stated in the document as would be found in a formal validation study. The closest information available pertains to the similarities in performance specifications and standards met.
| Acceptance Criteria (Inferred/General) | Reported Device Performance (from document) |
|---|---|
| Image Quality / Diagnostic Utility | The device is intended to "obtain dental x-ray panoramic tomography pictures by digital processing with a CCD sensor which is capable of electronic imaging over the whole Dento-maxillofacial area such as teeth, periodontal tissues or chin- bone etc." While no specific image quality metrics (e.g., resolution, contrast-to-noise ratio) are provided, the device is considered "substantially equivalent" to its predicate device (Veraviewepocs Model VE, K030699). The predicate device was cleared for producing dental radiographic examinations. The key difference in the new device is the replacement of film with a CCD sensor and the addition of automatic exposure control, which are presented as not raising new questions of safety or effectiveness. The document states "Performance spec. - International standards" and "Similar" to the predicate. This implies that the device is expected to meet the performance standards of similar dental panoramic X-ray units. |
| Safety (Electrical, Thermal, Radiation) | The device is stated to meet "International standards" and is "Similar" to the predicate device in terms of "Testing - VDE." Specifically, "Electrical safety - Similar," "Thermal safety - Identical," and "Radiation safety - Identical" to the predicate device are noted. This suggests the safety profile of the new device is considered equivalent to the predicate, which would have met established safety criteria for medical X-ray devices. |
| Functional Equivalence | The device performs "standard panoramic images, Pedodontic panoramic images, and TMJ quadruple images," which aligns with the functionality of the predicate and the intended use of such devices. The main difference (CCD sensor and automatic exposure control) is presented as an enhancement rather than a change in core functionality that would require new performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe any specific clinical or technical test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective study) for the Veraview IC 5 XDP1. The 510(k) pathway, especially for modifications to existing devices, often relies on engineering testing and comparison to a predicate rather than extensive clinical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The document does not describe a study involving expert review for establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable. As no specific clinical test set or expert review process is described, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is an X-ray imaging system, not an AI-powered diagnostic aid.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is an X-ray imaging system, not an algorithm, so standalone algorithm performance is not a concept relevant to this submission. The device is used by a human operator (the dentist/radiographer) to acquire images for diagnosis by a human clinician.
7. The Type of Ground Truth Used
Not applicable in the context of a conventional diagnostic study. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence primarily relies on:
- Engineering and technical specifications comparisons.
- Conformity to international safety standards (e.g., VDE).
- The known performance and safety profile of the legally marketed predicate device (Veraviewepocs Model VE, K030699).
The implicit ground truth is that the images produced by the new device are diagnostically acceptable and clinically equivalent to those from the predicate device.
8. The Sample Size for the Training Set
Not applicable. The device is an X-ray hardware system, not a machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, this question is not applicable.
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