(265 days)
The NAOMI-CT is used to take three- and two-dimensional x- ray images for the detection of dental abnormalities for a purpose of examination and diagnosis of diseases of the teeth, jaw, and oral structures.
NAOMI-CT is a diagnostic x-ray imaging system, which consists of computed tomography x-ray system and panoramic x ray system. It is used for detecting oral and maxillofacial abnormalities and diseases of patients of all ages and gender.
NAOMI-CT achieves above by utilizing CMOS and CCD sensors equipped in the system, and captures 3D computed tomography scanned image and 2D Panoramic X ray image of the oral and maxillofacial anatomy on a real time basis by computed reconstruction of x-ray image data from the same axial plane taken at different angles.
The provided text describes the NAOMI-CT device, a dental computed tomography X-ray system, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria for a device, a study designed to prove the device meets specific acceptance criteria, or any of the detailed questions you've asked regarding clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.).
The document focuses on:
- General information: Applicant, device name, classification, indications for use.
- Device description: How NAOMI-CT works (CMOS/CCD sensors, 3D CT, 2D panoramic X-ray).
- Substantial equivalence: Comparison to predicate devices (BEL-CAT Dental Cone Beam CT and E-Woo Dental Imaging System Model EPX-Impla), stating similar indications, performance, safety, and energy sources, with differences being cosmetic, structural, and component-based.
- Safety and performance testing: Mention of compliance with various IEC standards (60601-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 60601-2-44, and 60601-1-2 for EMC). It also notes performance of High Contrast Resolution, Low Contrast Resolution, Artifact, and Dosimetry Evaluation. All results were reported as "satisfactory."
- Conclusion: The device is considered safe and effective and substantially equivalent to predicate devices.
- FDA correspondence: A letter from the FDA confirming the 510(k) clearance based on substantial equivalence.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document states that "All test results were satisfactory" and "non-clinical & Clinical considerations in this submission prove that NAOMI-CT and predicate devices share the same qualities and characteristics," but it does not detail these "clinical considerations" or "test results" in a way that answers your specific questions about acceptance criteria or study design.
§ 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.