(17 days)
The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. Accessories to be used with the intraoral sensors include holders and hygienic covers. Use of the SIDEXIS differs from conventional X-ray imaging only due to the use of the PC and the X-ray sensors. The X-rays are produced using the customary method of the intraoral or extraoral X-ray system, however, an electronic, radiation sensitive sensor element is used in place of the conventional film carrier. The radiation is then converted into electronic signals that are relayed through cables connecting the sensor to the PC directly or through a network.
The SIDEXIS can be used with:
- Intraoral sensors and an intraoral dental X-ray device (e.g., Heliodent DS); and .
- Panoramic or cephalometric sensors and an extraoral source X-ray device (e.g., . Orthophos 3DS, DS, or DS Ceph).
The provided document is a 510(k) Special Summary for the SIDEXIS Digital Radiography Imaging System. This type of submission is for modifications to a device that has already received 510(k) clearance and relies on the substantial equivalence to a predicate device. It does not contain a study demonstrating that the device meets acceptance criteria in the way a de novo or a new 510(k) for a novel device would.
Instead, the submission focuses on validating that the modifications to the already cleared SIDEXIS system do not raise new questions of safety and effectiveness and that the modified device remains substantially equivalent to its predicate.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, and detailed study methodologies for proving performance against those criteria are not present in this document, as they would have been part of the original K972168 submission or are covered by the general principles of substantial equivalence for a modified device.
However, I can extract information related to the basis for substantial equivalence for this modified device:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) for modifications, specific numerical "acceptance criteria" and "reported device performance" in the context of clinical metrics (e.g., sensitivity, specificity for a diagnostic task) are not provided in this document. The acceptance for this submission is based on maintaining substantial equivalence to the predicate device after modifications.
The document states:
- "A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified to the original SIDEXIS Digital Radiography Imaging System."
This indicates that validation testing was performed, and the acceptance criterion appears to be that the modified device performs adequately and safely according to the design controls, and does not negatively impact the performance established for the prior cleared device (K972168). While the specific results of this validation testing are not detailed, the FDA's clearance implies these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided in this Special 510(k) document. The submission focuses on hardware and software modifications and their validation rather than a new clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided in this Special 510(k) document.
4. Adjudication Method for the Test Set
Not applicable/Not provided in this Special 510(k) document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not provided in this Special 510(k) document. The submission focuses on device modifications and substantial equivalence, not a comparative effectiveness study with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable/Not provided in this Special 510(k) document. This is an imaging acquisition system, not an AI algorithm for standalone diagnostic performance.
7. Type of Ground Truth Used
For the modifications described (additional sensors, acquisition boards, operating systems, computer platform), the "ground truth" would likely relate to objective physical measurements (e.g., image quality metrics like spatial resolution, contrast-to-noise ratio, signal-to-noise ratio) and functional verification (e.g., successful interface, software compatibility, system stability). This isn't a "ground truth" in the diagnostic sense (e.g., pathology report). The document implicitly states that these were validated through "validation testing" and compliance with "Design Controls."
8. Sample Size for the Training Set
Not applicable/Not provided in this Special 510(k) document. This is not an AI/machine learning device requiring a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in this Special 510(k) document.
§ 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.