(113 days)
I-MAX Touch 3D, panoramic X-ray imaging system with cephalostat, is an extra-oral source Xray system which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It also has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses a cone shaped X-ray beam projected on a flat panel detector; the examined volume image is reconstructed to be viewed on 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
The I-MAX Touch 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped with a cephalostat. The device can be equipped with accessories to fulfill different diagnostic needs. The images are acquired by a flat panel detector and are displayed on a monitor; image processing, manipulation, archiving, communication and 3D reconstruction (starting from cross-sectional images taken using CBVT (Cone Beam Volumetric Tomography) technique) are performed using a computer.
The provided 510(k) summary for the I-MAX Touch 3D does not contain specific acceptance criteria or an analytical study comparing its performance against predefined metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
- Information on a standalone (algorithm only) performance study.
- Type of ground truth used for testing.
- Sample size for the training set.
- How ground truth for the training set was established.
Rationale for this conclusion based on the provided text:
The submission focuses entirely on substantial equivalence to a predicate device (Villa Sistemi Medicali Rotograph EVO 3D, K111152). Key statements supporting this include:
- "The I-MAX Touch 3D has the same indication for use as the predicate device."
- "It is identical to the predicate device except for the design of some of its external plastic covers and for the control panel."
- "It shares the same technological characteristics as the predicate device."
- "The minor technological and design differences do not raise any new questions regarding safety or effectiveness of the device; both devices are used in the same identical way."
- "Conclusion: The I-MAX Touch 3D performs the same identical functions in the same environment as the predicate device. It uses the same technology as the predicate device, based on well-known technology. It is as safe and effective as the predicate device. We believe it does not introduce any new potential safety risks and is substantially equivalent and identical to the predicate device."
For devices seeking 510(k) clearance based on substantial equivalence, especially for a new device that is nearly identical to a predicate (as described here), a detailed performance study with specific acceptance criteria and ground truth evaluations like those requested are often not explicitly required in the 510(k) summary itself. The assumption is that since the technology and intended use are the same, the performance would be equivalent. The "testing" mentioned refers to compliance with safety standards (IEC 60601-1) and internal verification/validation, not a clinical or image quality comparison with a gold standard or human readers.
§ 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.