(106 days)
Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care.
Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.
i-CAT FLX V series / KaVo 3D eXam+ V series manufactured by Imaging Sciences International, is a Cone Beam Volumetric Tomography and Panoramic X-ray dental imaging system that consists of a scanner and a software package for image reconstruction. The two models, i-CAT FLX / KaVo 3D eXam+, are of identical design in the i-CAT Scanner family. The components of the system include the main affixed unit, the overhead, the gantry, the tube head, the X-ray source assembly and collimator, the receptor panel, and software package for image reconstruction. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. The V series refer to 3 different fieldof-view configurations (V8, V10, V17) available on each model based on licensing of the acquisition software.
The software package includes a device specific software package (SmartScan STUDIO) that is required to operate the i-CAT FLX System through a visual touchscreen interface and a post-processing imaging software. The modules within the device specific software perform the Image Acquisition, Quality Assurance, Device Calibration, and Image Reconstruction and Processing functionalities of the device. The software utilizes a modified Feldkamp algorithm for reconstruction. There is a basic DICOM viewer component (with limited image viewing capabilities) for the operator to ensure that the data collection and image processing are correct. Also provided with the device is a postprocessing imaging software, such as TxSTUDIO marketed under K123519. It is a volumetric imaging software designed specifically for dental clinicians, intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment. The imaging software reads DICOM data from dental CT machines, such as devices in the i-CAT family.
Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain cross-sectional images of the head or neck. The proposed device is a CBCT dental system with 2 modes of operation: panoramic and CBCT.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.
Important Note: The provided document is a 510(k) summary from the FDA for a dental imaging system (i-CAT FLX V series / KaVo 3D eXam+ V series). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for an AI algorithm's performance. Therefore, the information typically requested for AI/algorithm performance (like MRMC studies, specific expert adjudication details, ground truth establishment for a training set) is not present in this type of regulatory submission, as the device is a hardware imaging system with associated software for image acquisition and reconstruction, not an AI-driven diagnostic tool.
The "study" described here is more akin to a verification and validation of the imaging system itself to ensure it produces images of diagnostic quality compared to legally marketed predicate devices.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an imaging system and not an AI algorithm with specific performance metrics like sensitivity/specificity, the "acceptance criteria" revolve around demonstrating comparable image quality and functionality to predicate devices. The document implies that the acceptance criteria are met if the device can produce volumetric and panoramic images of the maxillofacial (including ENT) areas in the head, and these images are of equivalent diagnostic quality as the predicate devices. The specific quantitative metrics for image quality are implied through the comparison table and the general statement of "acceptable clinical effectiveness."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Preamble: Device produces volumetric and panoramic images of the head area (ENT and maxillofacial). | Confirmed. The device consists of an x-ray system providing two-dimensional images and three-dimensional volume reconstructions of the head area, including ENT and maxillofacial areas (TM Joint, mandible & maxilla for implant planning, sinuses, airway). |
| Image Quality: Images are of equivalent diagnostic quality as predicate devices. | "As evidenced through the Design Verification and Validation, the proposed device can produce volumetric and panoramic images of the maxillofacial (including ENT) areas in the head, and they are of equivalent diagnostic quality as the predicate devices." |
"Clinical images acquired using i-CAT FLX/KaVo 3D eXam+ were reviewed by qualified clinicians to be of acceptable clinical effectiveness for the proposed indications for use." No specific quantitative metrics (e.g., SNR, contrast, resolution values) from a comparative study are detailed in this summary. |
| Technological Equivalence/Safety: Minor technological differences do not affect imaging of anatomical structures or raise new safety concerns. | "The minor technological difference in the shape of image volumes does not affect imaging of the intended anatomical structures."
"Based upon an analysis of the technological differences, and the substantiation through design verification and validation, ISI determines that the proposed i-CAT FLX / KaVo 3D eXam+ is substantially equivalent to the predicate devices... and does not raise any new concerns."
Compliance with various IEC standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-63, 62366) and biocompatibility testing was also reported. |
| Functional Equivalence: Device offers similar functionalities to predicate devices. | The device provides "3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data," similar to its predicates. It supports various imaging procedures (implants, TM Joints, reconstructed panoramic/cephalometrics, airway/sinus, nerve canal, conventional digital panoramic). |
Study Details (as inferable from the document)
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Sample Size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively. The document states "Clinical images acquired using i-CAT FLX/KaVo 3D eXam+ were reviewed." This implies a set of clinical images were used, but the number of cases or patients is not provided.
- Data Provenance: Not specified (e.g., country of origin). It's a general statement about "clinical images." It reads as if the images were likely prospectively acquired using the device itself for testing purposes, rather than being a retrospective dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document states "reviewed by qualified clinicians."
- Qualifications of Experts: "Qualified clinicians" is the only description provided. Specifics like "radiologist with 10 years of experience" are not mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. It merely says "reviewed by qualified clinicians." There's no indication of a consensus or adjudication process.
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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, an MRMC study was not detailed. This submission is for an imaging system hardware/software combination, not an AI-assistance diagnostic tool.
- Human Reader Improvement with AI: Not applicable, as this device itself is the image acquisition and reconstruction system, not an AI for image interpretation or reader assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable in the context of an AI algorithm. The "algorithm" here refers to the image reconstruction algorithm (modified Feldkamp algorithm), and its performance is inherently evaluated through the diagnostic quality of the reconstructed images, which were "reviewed by qualified clinicians to be of acceptable clinical effectiveness."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this type of submission is the diagnostic quality perceived by qualified clinicians when reviewing images produced by the device, implicitly compared against what they would expect from a predicate device. It's not a "ground truth" for a specific disease or condition in the way a pathology report would be.
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The sample size for the training set:
- Sample Size: Not applicable. This document does not describe the development or training of a machine learning or AI model; it describes a medical imaging device. The "training set" concept does not apply here.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no "training set" in the context of an AI model's development in this submission. The image reconstruction algorithms are based on physics and mathematical principles, not trained on a dataset with "ground truth" labels.
§ 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.