(48 days)
The intended use of the Midmark EOIS is to provide dental radiographic examination to aid in the diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will provide cephalometric radiographic examinations for use in orthodontic treatment planning and evaluation. When the system is equipped with the CBCT option, the system will also provide volumetric and tomographic images of the oral and maxillofacial region, for diagnostic examination of teeth, jaws, oral structures, and some cranial bones.
The Midmark Extraoral Imaging System (EOIS) is a diagnostic X-ray system using an extraoral source intended for dental radiographic examination and diagnosis of diseases for the following regions of the patient's anatomy:
- . dental (teeth)
- . oral and maxillofacial region (mouth and jaw)
It produces the following radiographic images: - . Panoramic (PAN) images used for diagnostic examination of dentition (teeth), jaws and oral structures.
- Cephalometric (CEPH) images of maxillofacial region and parts of the skull for CEPH examination, if equipped with the CEPH feature.
- . Carpal images assisting in estimating bone-age, if equipped with the CEPH feature, and when the carpal attachment is used.
- . Cone Beam Computed Tomography (CBCT) volumetric and tomographic images of the oral and maxillofacial region for diagnostic examination of dentition (teeth), jaws, oral structures, and some cranial bones, if equipped with the CBCT small or medium feature.
The main modality is limited to PAN radiographic images but can be upgraded by installing the CEPH imaging feature, allowing the device to provide CEPH radiographic images for use in orthodontic treatment planning and evaluation. This extension is also intended to allow carpal imaging to assist in estimating bone-age.
The Midmark EOIS can be upgraded by installing a 3D option allowing the device to produce computed volumetric and tomographic images of the listed above anatomy regions by computed tomographic reconstruction of the digital X-ray data. The X-ray data is captured by two dimensional images taken by exposing the patient anatomy at different anales with a cone shaped X-ray beam. Reconstruction software converts these two-dimensional images into a three-dimensional data set.
The provided text focuses on the K201667 510(k) submission for the Midmark Extraoral Imaging System (EOIS), detailing its indications for use, technological characteristics, and non-clinical performance data.
However, it does not contain detailed information about acceptance criteria for an AI device, nor does it describe a study that explicitly proves an AI device meets such criteria. The document describes a traditional medical imaging device (X-ray system) and its performance, not an AI/ML medical device.
Therefore, I cannot extract the specific information requested in the prompt regarding AI device acceptance criteria and study details. The document describes:
- Non-clinical Performance Data (Section 5.6): This includes medical electrical safety testing, imaging performance testing (against IEC 61223-3-4), dose comparison evaluation, and CBCT modality testing.
- Clinical Performance Data (Section 5.7): This mentions an "Image Performance study" (evaluating image quality of phantom images by dental practitioners for diagnostic acceptability) and a "Usability study" (examining use-related hazards with simulated use involving clinicians).
None of these describe an AI study with its specific acceptance criteria as detailed in the prompt's numbered requests. The "Reconstruction Engines" and "iterative reconstruction" mentioned in Section 5.4 are image reconstruction algorithms, not AI algorithms designed for diagnosis or specific clinical tasks requiring the kind of rigorous AI validation outlined in the prompt.
Given the provided text, I must state that the information required to answer the prompt's specific questions about AI device acceptance criteria and a study proving it meets them is NOT present.
The document discusses imaging system performance and safety, but not AI model performance against explicit clinical acceptance criteria.
§ 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.