(76 days)
The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.
The ScanARay Advanced Computerized X-Ray System is a filmless system intended for digital intraoral and extraoral radiography using a phosphor storage screen. It enables the dentist to scan or import images for display, review or storage in a database. It consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a user-provided personal computer.
Unfortunately, the provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The document is a 510(k) summary for the ScanARay Advanced Computerized X-Ray System, which focuses on establishing substantial equivalence to predicate devices for regulatory clearance.
It describes the device, its intended use, and lists predicate devices, but it does not include the following information requested:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory equivalence, not specific performance metrics against defined criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device predates widespread AI integration in medical imaging, and the document itself makes no mention of AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and again, consistent with the device's era and description, it's unlikely a standalone algorithm performance study as understood today would have been conducted or relevant.
- The type of ground truth used: Not explicitly stated. For an X-ray system, the ground truth would typically be the clinical assessment by a dentist from the radiographic images, but the specifics of how this was established for any performance testing are absent.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion:
The provided document is a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence to existing devices for market approval. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in clinical validation studies for a new device's specific claims or AI components.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.