(71 days)
The Master3DS is a X-ray, tomography, computed, dental that provides 3D imaging of dental and maxillofacial for diagnosis and treatment planning.
E-WOO Dental Imaging system Master3DS 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 Master3DS 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 510(k) summary for the E-WOO Dental Imaging system Master3DS does not contain details about specific acceptance criteria, a study proving device performance against those criteria, or most of the requested information about a clinical study.
The submission focuses on establishing substantial equivalence to a predicate device (i-CAT) based on general device features and compliance with electrical, mechanical, and safety standards. It does not provide performance metrics or details of a clinical study designed to demonstrate a given level of diagnostic accuracy or effectiveness.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. The 510(k) focuses on substantial equivalence based on safety and general features, not on specific performance metrics or diagnostic accuracy targets. | The device provides "high quality digital image," "clear Tomography image upto minimum 0.1mm at any directions," and "drastically reduce X-Ray expose dose comparing with medical CT." However, these are descriptive claims rather than quantifiable performance metrics linked to acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The submission does not describe a clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified, as no clinical study with a ground truth assessment is described.
4. Adjudication method for the test set
- Not applicable, as no clinical study with a test set requiring adjudication is described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. The device is a diagnostic imaging system, not an AI-assisted diagnostic tool for human readers in the context of this 510(k).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is an imaging system; its performance is inherent in the image quality it produces, not in an algorithm's standalone diagnostic capability in the absence of a human interpreter.
7. The type of ground truth used
- Not specified, as no clinical study requiring a ground truth is described.
8. The sample size for the training set
- Not applicable. This device is an X-ray imaging system, not an AI/machine learning algorithm requiring a "training set" in the conventional sense for diagnostic performance.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
Summary of the Study Mentioned (Non-Clinical):
The provided text mentions non-clinical testing to ensure the safety and performance of the Master3DS. This testing included:
- Electrical, mechanical, and environmental safety and performance testing: According to standards EN/IEC 60601-1, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32, and EN/IEC 60601-2-44.
- EMC testing: Conducted in accordance with standard EN/IEC 60601-1-2 (2001).
The conclusion was that "All test results were satisfactory," indicating that the device met the requirements of these engineering and safety standards. This type of testing ensures the device is built safely and functions as intended from an engineering perspective, but it does not evaluate its diagnostic accuracy or clinical effectiveness in a patient population.
§ 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.