(185 days)
The Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
E-WOO Dental Imaging system Picasso-Duo is a Computed Tomography X-ray System. Computed Tomography (CT) provides valuable 3-D imaging of the dental and maxillofacial structures for diagnosis and treatment planning. Uses of CT imaging include for assessment of impacted teeth, root configurations and mandibular condyle evaluation. This technology allow for 3-D imaging but at lower equipment cost, simpler image acquisition and lower patient radiation dose.
Model Picasso-Duo is diagnostic equipment which consists of panoramic dental x-ray system and computed tomography x-ray system. The panoramic dental x-ray is a system based on digital and computed tomography (CMOS CT Sensor to Capture 3D x-ray Computerized tomogram scanned image)
The provided text is a 510(k) summary for the Picasso-Duo Computed Tomography X-ray System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics from such a study.
The summary focuses on regulatory compliance, electrical, mechanical, and environmental safety, and performance testing according to established IEC standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-44, and IEC 60601-1-2 for EMC). It states that all test results were satisfactory, implying the device meets the safety and performance requirements of these standards.
Without a dedicated study section, specific details regarding acceptance criteria for diagnostic accuracy, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications are not present in this document.
Therefore, I cannot populate the requested table or answer most of the questions as the information is not provided in the input text.
However, based on the information provided, here are the answers I can deduce or explicitly state:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for a particular condition). The implied acceptance criteria are compliance with the referenced IEC safety and performance standards.
- Reported Device Performance: "All test results were satisfactory" for electrical, mechanical, environmental safety, and performance testing according to the specified IEC standards. The device is also stated to provide "high quality digital image" and "A clear Tomography image upto minimum 0.1mm at any directions."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
5. 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:
- No mention of an MRMC study or AI assistance. This device is a Computed Tomography X-ray system, not an AI-powered diagnostic tool in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a medical imaging device, not a standalone algorithm in the context of diagnostic performance evaluation mentioned in the request.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not specified. (Likely relies on physical measurements and image quality metrics rather than clinical ground truth for a diagnostic accuracy study, as none is described).
8. The sample size for the training set:
- Not specified. (Not applicable for this type of device submission which doesn't describe an AI training process).
9. How the ground truth for the training set was established:
- Not specified. (Not applicable).
Summary of what the document DOES state regarding performance/testing:
The device's safety and performance are affirmed by compliance with a series of IEC standards:
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-1 (Safety requirements for medical electrical systems)
- IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment)
- IEC 60601-2-7 (Particular requirements for the safety of high-voltage generators for diagnostic X-ray equipment)
- IEC 60601-2-28 (Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies)
- IEC 60601-2-32 (Particular requirements for the safety of associated equipment for X-ray equipment)
- IEC 60601-2-44 (Particular requirements for the safety of X-ray equipment for computed tomography)
- IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)
The document asserts that "All test results were satisfactory" for these standards tests. It also mentions features like "high quality digital image" and "A clear Tomography image upto minimum 0.1mm at any directions."
§ 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.