(16 days)
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.
Cranex D is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. The device is upgradeable for cephalometric radiography. Cranex D utilizes digital image receptor(CCD).
Here's an analysis of the provided text regarding the Cranex D device, focusing on acceptance criteria and study details.
Based on the provided text, the Cranex D device is a dental panoramic x-ray system, and the 510(k) submission primarily focuses on establishing its substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI or diagnostic algorithm.
Therefore, many of the requested points related to AI performance, expert adjudication, MRMC studies, and standalone performance are not applicable or not explicitly mentioned in this document, as the submission deals with an X-ray imaging device itself, not an AI-powered diagnostic tool.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in the way one would for a diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance is described in terms of its ability to produce digital images of dentition and its equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Orthophos DS / DS Ceph and Cranex Basex D or Cranex Excel D) | "Verification and validation testing was successfully performed to confirm that Cranex D corresponds with the intended use." |
| Production of Digital Radiographs of Dentition, TM-joints, and other oral structures | "Cranex D utilizes digital image receptor (CCD)." "The technique factor settings for panoramic examinations are: 57 – 85 kVp, 10 mA DC and 17.6 s max. The technique factor settings for cephalometric radiographs are: 60 - 85 kVp, 10 mA DC and 8 - 20 s." |
| Upgradeability for Cephalometric Radiography | "The device is upgradeable for cephalometric radiography." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document states "Verification and validation testing was successfully performed," but does not detail the size or nature of the test set (e.g., number of patients, images).
- Data Provenance: Not specified. This typically isn't detailed in 510(k)s for X-ray equipment itself, but rather for diagnostic software that processes images.
- Retrospective or Prospective: Not specified.
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. This information is relevant for evaluating diagnostic output, not for a device that captures images. The "ground truth" for an X-ray machine is its physical and image-quality performance as per engineering and clinical standards, typically assessed through phantom studies and image quality evaluations rather than expert consensus on patient cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is mentioned, as the "test set" in this context likely referred to technical performance evaluations rather than diagnostic interpretation.
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. The Cranex D is an X-ray imaging device, not an AI-assisted diagnostic tool. Therefore, no MRMC study comparing human readers with and without AI assistance would have been performed or reported for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Cranex D is an X-ray imaging device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the diagnostic sense (e.g., pathology) is not applicable to the device itself. For an X-ray machine, "ground truth" relates to its technical specifications and image quality parameters, which would be verified against engineering standards and phantom measurements. The document does not specify the exact methods for verifying these, only that "Verification and validation testing was successfully performed."
8. The sample size for the training set
Not applicable. This device is an X-ray machine, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is an X-ray machine, not an AI algorithm requiring a training set with established ground truth.
§ 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.