Search Results

'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.

In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.

This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic images by rotating arm to get the recombination data, X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector, When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense, On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-ray is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.

The eco-x Series consists of 2 different models. The eco-x-s supports cephalometric scan compared with the eco-x, which do not support CEPH mode.

The provided text is a 510(k) Summary for the eco-x Series, a dental X-ray imaging device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, especially in terms of clinical performance or human-in-the-loop studies (MRMC).

The document mentions "non-clinical test summary" and "performance test" related to imaging properties and patient dosage, but these are bench tests and not clinical studies with acceptance criteria for diagnostic performance.

Therefore, I cannot fulfill most of your request as the information is not present in the provided document.

Here's what I can extract based on the limited information related to performance:

1. Table of acceptance criteria and reported device performance:

The document mentions meeting standards like IEC 61223-3-4 for imaging performance and providing MTF and DQE values for detectors. However, it does not explicitly state "acceptance criteria" alongside specific "reported device performance" in a table format for diagnostic accuracy or clinical utility of the device in a human setting. The table below reflects the bench test results compared to predicate devices, rather than clinical acceptance criteria.

Regarding the other points of your request, the document does NOT provide information on:

• 2. Sample size used for the test set and the data provenance: The document mentions "bench testing" but provides no details on "test sets" in the context of patient data, number of cases, or data provenance (country of origin, retrospective/prospective).
• 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable as no clinical ground truth establishment is described.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: No, the document explicitly states "Non-Clinical Test Summary" and focuses on comparison to predicate "technological characteristics" rather than clinical effectiveness or human reader performance. This device is a traditional X-ray imaging system, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "software validation" for the original software and OTS software (image viewer) and mentions an image reconstruction algorithm (FBP). However, it does not refer to an "algorithm only" performance study in the sense of an AI model's diagnostic accuracy. The performance tests mentioned are related to hardware performance (image quality, dose) of the X-ray system itself.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests conducted, the "ground truth" would be physical measurements of image quality parameters (e.g., resolution targets for MTF, dose meters for CTDIw/DAP) and not clinical diagnostic outcomes or expert consensus.
• 8. The sample size for the training set: Not applicable as this is not an AI/machine learning device with a training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) Summary for a medical imaging device, demonstrating substantial equivalence through technical comparisons and bench testing against established standards and predicate devices. It does not include information on clinical acceptance criteria or studies involving human readers or AI performance.

Ask a specific question about this device