(21 days)
ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the cranio-maxillofacial complex for use in diagnostic support.
ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.
ORTHOPANTOMOGRAPH™ OP 3D x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic and 3D images of the cranio-dentomaxillofacial complex of patient head. The ORTHOPANTOMOGRAPH™ OP 3D has panoramic programs (adult, child, TMJ, BW and partial) and 3D (CBCT) programs with different 3D Field of View configurations. The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), upper shelf, patient head support and driver software including image reconstruction. Workstation software for viewing the images is not included in this submission.
The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.
The provided text is related to a 510(k) premarket notification for a dental x-ray device (ORTHOPANTOMOGRAPH™ OP 3D). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often seen in AI/CAD device submissions.
Based on the provided information, I can answer some of your questions, but many of the requested details are not available or applicable to this type of submission.
Here's an analysis based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for diagnostic performance or clinical effectiveness of the device in the way you might expect for an AI/CAD system. Instead, the "acceptance criteria" are implied by the conformity to various standards and the demonstration of "equivalent diagnostic quality" to a predicate device through non-clinical testing and clinician review of bench test images.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to electrical, mechanical, safety, and performance standards (IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-2-63, IEC 60601-2-28, IEC 60601-1-3) | The proposed ORTHOPANTOMOGRAPH™ OP 3D has successfully passed internal design verification and validation, and all tests conducted by a 3rd party test house. |
| EMC conformity (IEC 60601-1-2) | EMC testing was conducted in accordance with standard IEC 60601-1-2:2014, and the proposed ORTHOPANTOMOGRAPH™ OP 3D has passed all tests. |
| Biocompatibility of patient-contacting parts (ISO 10993-1) | Biocompatibility evaluation was conducted on patient contacting accessory parts and their material and found to be in conformance with ISO 10993-1. |
| Acceptable diagnostic quality of images for the proposed Intended Use (for bench test images) | Bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D were reviewed by qualified clinicians to be of acceptable quality for the proposed Intended Use. |
| Software categorized as Moderate Level of Concern and documented according to Guidance. | Software for ORTHOPANTOMOGRAPH™ OP 3D has been categorized as Moderate Level of Concern and documented according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. |
| Substantial equivalence to predicate device (ORTHOPANTOMOGRAPH™ OP300, K133544) regarding safety and effectiveness. | Minor differences have been shown not to affect the substantial equivalence. Nonclinical tests demonstrate substantial equivalence regarding safety and effectiveness. All internal verification and validation have been completed successfully. The device is substantially equivalent to the predicate device. |
| Technical Resolution: System MTF @10%, FOV 5x5 High Res (for 3D resolution) | Proposed Device: 2.2 lp/mm @125µm voxel |
| Predicate Device: 2.25 lp/mm @125µm voxel (This shows comparability, implying the proposed device meets the standard set by the predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses "bench test images" and "non-clinical performance data." It explicitly states: "No clinical images were utilized for this submission. Clinical data was not needed to support substantial equivalence." Therefore, no sample size, data provenance, or other details related to a clinical test set are provided. The "test set" for diagnostic quality appears to be composed of "bench test images."
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)
The document mentions "qualified clinicians" reviewed the bench test images for acceptable quality. However, it does not specify:
- The number of clinicians.
- Their specific qualifications (e.g., years of experience, specialty).
- How ground truth was established, beyond their review for "acceptable quality."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no mention of a formal adjudication method for the "qualified clinicians" reviewing bench test images.
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
No MRMC study was performed. The device is an imaging system, not an AI/CAD system assisting human readers. The submission relies on demonstrating substantial equivalence to a predicate imaging device through technical and performance comparisons.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/CAD algorithm. It is an x-ray imaging device. The performance evaluated is the image quality and physical/electrical safety of the device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "bench test images" that were reviewed, the "ground truth" seems to be an implicit assessment by "qualified clinicians" that the image quality was "acceptable" for diagnostic support. No formal "ground truth" (e.g., pathology, clinical outcomes) for specific diagnoses is mentioned, as this was not a diagnostic accuracy study.
8. The sample size for the training set
Not applicable. This is an X-ray imaging device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.