(268 days)
PREXION3D ECLIPSE is intended to produce two-dimensional digital panoramic and cephalometric images, and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support.
The PREXION3D ECLIPSE consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION3D ECLIPSE.
The PREXION3D ECLIPSE uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device.
During scanning, X-rays are generated from the X-ray tube head mounted in the arm of the scanner and the X-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on each computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial region for the diagnosis of hard tissue
The PREXION3D ECLIPSE performs three types of scanning including CT scan generating two (2) or three (3) dimensional images, Panoramic scan generating two (2) dimensional images and Cephalometric radiography generating a plain radiographic image.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This submission is for a medical device (PREXION3D ECLIPSE), which is an X-ray system. The information provided heavily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with recognized standards, rather than clinical performance studies with specific patient outcomes.
Therefore, the answers to some of your questions may indicate that the information is "Not applicable," "Not specified," or "Not performed" based on the nature of this type of regulatory submission (510(k) for substantial equivalence).
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in the typical sense of performance metrics (sensitivity, specificity, accuracy) for a diagnostic algorithm with a defined ground truth. Instead, the "acceptance criteria" are implied by the demonstration that the device's characteristics and performance are substantially equivalent to existing legally marketed predicate devices and that it meets recognized consensus or voluntary standards relating to safety and effectiveness of X-ray systems.
The studies performed are primarily bench tests and verifications of safety and technical specifications, aiming to show that the new device performs at least as well as, or comparably to, its predicates in these areas.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Laser Safety Compliance (e.g., meeting IEC 60825-1) | Met: Laser system is identical to PANOURA 18S (K111231), for which test report IEC 60825-1 is used. |
| Spatial Resolution (e.g., meeting MTF criteria per IEC 61223-3-5) | Met: Spatial resolution of all scan modes met the acceptance criteria. |
| Artifact Analysis (e.g., comparable to predicate device) | Met: No difference in pattern and strength of metal artifact between PREXION3D ECLIPSE and FINECUBE (K063622). |
| Software Validation (e.g., per FDA guidance) | Met: Software validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| EMC Compliance (e.g., meeting IEC 60601-1-2) | Confirmed: In accordance with IEC60601-1-2. |
| Electrical Safety (e.g., meeting IEC 60601-1) | Confirmed: In accordance with IEC60601-1, IEC 60601-1-1. |
| X-ray Radiation Safety (e.g., meeting IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32) | Confirmed: In accordance with relevant IEC 60601-2 standards. |
| Overall Substantial Equivalence to predicates | Concluded: PREXION3D ECLIPSE is substantially equivalent to predicate devices (FINECUBE, CS 9300, PANOURA 18S) and does not raise new questions on safety/effectiveness. |
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: Not explicitly specified in terms of patient cases or images for any of the bench tests mentioned. The "images of all scan mode" were compared for artifact analysis, implying a limited set of test images rather than a large patient cohort.
- Data Provenance: Not specified. The tests are described as "bench tests," suggesting they likely involved phantom or test objects rather than human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. The evaluation criteria are based on objective technical standards (IEC standards, MTF measurements, direct comparison of artifact patterns) rather than expert consensus on diagnostic accuracy for a "ground truth" derived from patient cases.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The evaluations are technical and objective (e.g., measuring MTF, comparing artifact patterns), not subjective diagnostic interpretations requiring adjudication.
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
- MRMC Study: No. This type of study is not mentioned or implied. The device is an X-ray imaging system, not an AI-powered diagnostic aide.
- Effect Size of AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is an imaging system; its performance is evaluated based on its imaging capabilities (resolution, artifact, safety compliance) rather than an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "bench testing" described, the "ground truth" is intrinsically tied to the recognized standards and objective physical measurements. For example:
- For Laser Safety, the ground truth is compliance with IEC 60825-1.
- For Spatial Resolution, the ground truth is the derived MTF values meeting specified criteria according to IEC 61223-3-5.
- For Artifact Analysis, the ground truth is the visual comparability to the images from the predicate device (FINECUBE, K063622).
- For Software Validation, the ground truth is adherence to FDA guidance documents.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This is an X-ray hardware and software system, not a machine learning model that requires a "training set" in the conventional sense. Software validation would involve testing against requirements, but not a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there's no mention of a machine learning training set, this question is not relevant to the provided documentation.
§ 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.