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510(k) Data Aggregation
(109 days)
Will3D is a software application used for the display and 3D visualization of medical image files from scanning devices, such as Dental CT scanner. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
The provided document is a 510(k) premarket notification for the medical device "Will3D," a software application for dental imaging. It outlines the device's intended use, technological characteristics, and comparison to predicate devices to establish substantial equivalence.
However, the document states: "No clinical studies were considered necessary and performed."
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be provided from this document because no clinical studies were conducted to prove the device meets acceptance criteria derived from such studies. The equivalence is established purely on technological characteristics and intended use compared to predicate devices.
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(405 days)
The X-VIEW, IMAGEN, a panoramic x-ray imaging system with cephalometric capabilities, is an extraoral source x-ray system intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMI studies and cephalometry. It has the capability of using cone beam volumetric technology techniques to generate dento-maxillofacial 3D images. The device uses a cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed via 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals.
X-VIEW, IMAGEN is a 3-dimensional CBCT system that allows the execution of all commonly used x-rays in both dental and orthodontic fields (excluding intraoral radiographs) and also allows the acquisition of tomographic radiographs, or volumetric 3D. It uses CBCT (Cone Beam Computed Tomography) with a flat panel detector to provide high-definition volumetric images.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the X-VIEW, IMAGEN device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in a quantitative manner (e.g., minimum sensitivity, specificity, or resolution thresholds for clinical performance). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to safety and performance standards.
| Criterion | Acceptance / Status | Reported Device Performance |
|---|---|---|
| Technical Specifications (Comparison to Predicates) | Substantially Equivalent | |
| - Indications for Use | Same as predicate devices | X-VIEW, IMAGEN: Dental radiographic examination of teeth, jaw, oral structures (panoramic, implantology, TMI, cephalometry), and 3D dento-maxillofacial images using CBCT. Operates by dentists, radiologists, and other qualified healthcare professionals. |
| - Generator/Tube X-ray Generator | High Frequency (Matches predicates) | High Frequency |
| - Focal Spot Size (mm) | 0.5 (Matches predicates) | 0.5 |
| - Tube Voltage (kV) | Within predicate ranges | 61-85 kV |
| - Tube Current (mA) | Within predicate ranges | 4-10 mA |
| - 3D Technology | Cone-beam computed tomography (Matches predicates) | Cone-beam computed tomography |
| - FOV (D x H) (mm) | 85 x 85 mm (Comparable to predicate Planmeca ProMax 3D's 80 x 80 mm; smaller than Papaya 3D Plus's 140 x 140 mm max) | 85 x 85 mm |
| - Exposure Time (sec) | 13.8 (PAN), 18 (CT) (Comparable but different from predicates: Planmeca 6 (PAN)/18 (CT), Papaya 17 (PAN)/15 (CT)/12 (CEPH)) | 13.8 (PAN), 18 (CT) |
| - Sensor Technology | CMOS Flat-panel detector (Matches predicates) | CMOS Flat-panel detector |
| - Sensor Pixel Pitch (µm) | 100 x 100 µm (Matches Papaya 3D Plus CT; different from Planmeca's 127 x 127 µm and Papaya's PAN/CEPH 75 x 75 µm) | 100 x 100 µm |
| - Active Area (mm) | 130 x 130 mm (Matches Planmeca ProMax 3D; different from Papaya 3D Plus's various active areas for different modes) | 130 x 130 mm |
| Safety and Performance Standards Compliance | Compliance demonstrated | Tested for compliance to IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, EN 62304. |
| Detector Performance (FDA Guidance "Submissions of 510(k)'s for Solid State X-Ray Imaging Devices") | Satisfactory | MTF: 50-57% at 1.0 lp/mm. DQE: ~70% at 0 lp/mm. Dynamic Range: 66-69 dB. |
| Clinical Evaluation Report | Satisfactory | Volumetric reconstructive images of a human subject were acquired. All test results were satisfactory, indicating the device is as safe and effective as predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions that a "Clinical Evaluation report in which volumetric reconstructive images of a human subject were acquired." This indicates a very limited sample size of one human subject for the clinical evaluation component and is explicitly stated as one human subject.
- Data Provenance: The document does not specify the country of origin of the data. It implies a prospective test set since it describes images being "acquired."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). The clinical evaluation report simply states that "all test results were satisfactory," implying an internal assessment rather than an independent expert review with explicit ground truth labeling.
4. Adjudication method for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of human readers improving with or without AI assistance. The device is an imaging system, and the evaluation focuses on its technical performance and equivalence to predicates, not on the impact of AI on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the typical sense of AI algorithms. The "device" here is a hardware imaging system (X-VIEW, IMAGEN) with associated imaging processing software (OnDemand3D). The evaluation is of the imaging system's ability to acquire and reconstruct images, not of a standalone AI algorithm to interpret images. The performance metrics (MTF, DQE, Dynamic Range) relate to the detector's standalone technical performance as an imaging component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the clinical evaluation. Given the nature of a CBCT system, the "satisfactory" test results for images of a human subject likely imply that the images were deemed diagnostically acceptable and of sufficient quality for their intended use by the evaluating party, possibly against known anatomical features or expected image characteristics, but it doesn't specify a formal ground truth like pathology or expert consensus on clinical findings.
8. The sample size for the training set
No training set is mentioned or implied for the evaluation of this device. The X-VIEW, IMAGEN is an imaging acquisition system. Its evaluation focused on hardware specifications, compliance with standards, and a limited clinical evaluation, not on the performance of a machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned.
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