(128 days)
The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
The Orthopantomograph OP300 is an extra oral source dental x-ray device that is softwarecontrolled which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software.
The provided text describes a 510(k) premarket notification for a modified dental X-ray device, the OP300. The submission aims to demonstrate substantial equivalence to a predicate device (also an OP300, K122018) rather than presenting a novel device that requires extensive clinical studies. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering and bench testing, demonstrating that the modifications do not negatively impact safety or effectiveness.
Here's an analysis based on the provided text, recognizing that this is a 510(k) submission for a modification, not a de novo device requiring broad clinical trials:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by complying with recognized consensus standards and demonstrating equivalent image quality and performance to the predicate device through bench testing.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (Modified OP300) |
|---|---|---|
| Image Quality Equivalence | No significant differences in image quality compared to the predicate OP300 (K122018) | Concluded that there are no significant differences in image quality. |
| Sensor Performance Equivalence | Equivalent sensor performance to the predicate OP300 (K122018) | Concluded that there are no significant differences in sensor performance. |
| Compliance with Consensus Standards | IEC60601-1:1988 (Medical electrical equipment - Part 1: General requirements for safety) | Compliant |
| IEC60601-1-2:2001 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Compliant | |
| IEC 60601-1-3:1994 (Medical electrical equipment - Part 1-3: General requirements for safety - Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment) | Compliant | |
| IEC60601-1-4:1996 (Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems) | Compliant | |
| IEC 60601-2-7:1998 (Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators) | Compliant | |
| IEC 60601-2-28:1993 (Medical electrical equipment - Particular requirements for the safety of X-ray source assemblies and X-ray generators for medical diagnosis) | Compliant | |
| IEC 60601-2-32:1994 (Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment) | Compliant | |
| Anthropomorphic Phantom Evaluation | Produce images without severe defects in 3D imaging mode. | Demonstrated capability of producing images without severe defects. |
| Software Validation | Successful validation of GUI software to incorporate new features (FOVs, low-dose mode). | Successfully verified and validated. |
| Safety and Effectiveness | Ensure the safety and effectiveness of the device (overall). | Successfully verified and validated. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For image quality and sensor performance, the testing involved comparing the modified OP300 against the predicate OP300 (K122018). The specific number of images or runs is not explicitly stated, but it was "in-house Performance (bench) testing."
- For the anthropomorphic phantom evaluation, it involved "images of an anthropomorphic phantom." The number of images is not specified.
- Clinical images of patients were explicitly not used to support substantial equivalence.
- Data Provenance: The testing was "in-house" bench testing, conducted by the manufacturer (PaloDEx Group Oy) in Finland. This indicates internal, controlled testing, not necessarily independent third-party validation. The data is retrospective in the sense that it's comparing a new version to an existing (predicate) version's performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No external experts or clinicians were explicitly stated as establishing ground truth for the bench test set. The evaluation of "image quality" and "sensor performance" likely relied on internal engineering and quality control staff, comparing objective metrics and potentially subjective assessments by qualified personnel. The statement "it was concluded that there is no significant differences in image quality" implies an internal assessment.
4. Adjudication Method for the Test Set
No formal adjudication method (like 2+1 or 3+1 by multiple experts) is mentioned, as clinical data was not used. The determination of "no significant differences" in image quality and sensor performance appears to be a conclusion drawn from the in-house bench testing results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was conducted. The submission explicitly states: "Sample clinical images of patients were not used to support substantial equivalence of the OP300 device." This means there was no human reader component to the "effect size of how much human readers improve with AI vs without AI assistance" as there is no AI assistance feature discussed in the submission, and no human reader study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is an imaging system, not an algorithm being validated in isolation. The "standalone" performance relates to its ability to produce images compliant with standards and equivalent to the predicate, which was assessed through bench testing. The reconstruction software (FBP or ART) operates in a "standalone" fashion to generate the 3D view from 2D projections, but its performance was evaluated in terms of image quality metrics from the phantom, not through a separate algorithm-only study.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission primarily relies on:
- Engineering benchmarks and specifications: Adherence to the technical parameters and performance characteristics established for the predicate device.
- Consensus Standards: Compliance with recognized international standards (IEC 60601 series).
- Anthropomorphic phantom images: The "truth" for these images is the known anatomical/radiological features within the phantom, and the assessment looked for "severe defects" rather than diagnosing a specific condition.
8. The Sample Size for the Training Set
This submission is for a device modification (hardware and GUI changes), not a new algorithm that requires a separate training set. The device uses established image reconstruction techniques (FBP, ART) which do not involve deep learning or AI requiring a "training set" in the modern sense. Therefore, there is no mention of a training set sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.