(61 days)
The "Brilliance Volume" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
The "Brilliance Volume" is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
This 510(k) summary for the "Brilliance Volume" CT scanner does not contain the detailed information required to describe acceptance criteria and a study that proves the device meets those criteria, as typically found in a clinical performance study report.
The document focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to general safety and quality standards. There is no mention of specific performance metrics, clinical studies, or an evaluation of an AI algorithm's performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of your specific questions. However, I can extract information relevant to your inquiry based on the provided text, highlighting what is missing.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Philips Plus K033326) by stating that "Brilliance Volume" has "similar technological characteristics and sub-assemblies." There are no reported performance metrics (e.g., sensitivity, specificity, accuracy) or explicit acceptance criteria for a new device's performance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present. The document does not describe any specific test set or data used to evaluate the device's performance.
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):
This information is not present. Since no test set or performance evaluation is described, there's no mention of experts or ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present.
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:
This information is not present. There is no mention of an MRMC study, human readers, or AI assistance. This device is a CT scanner, not explicitly an AI-driven image analysis tool in the context of this 2006 submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present. The document describes a CT scanner, a hardware device, not an algorithm being evaluated in a standalone capacity for diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present.
8. The sample size for the training set:
This information is not present.
9. How the ground truth for the training set was established:
This information is not present.
Summary of available information related to your questions (mostly noting what is absent):
| Question | Information from K060937 (2006) for "Brilliance Volume" CT Scanner |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Not Present. The submission |
| demonstrates substantial equivalence based on similar technological characteristics to a predicate device (Philips Plus, K033326), not specific performance metrics against acceptance criteria. | |
| 2. Test Set Sample Size & Data Provenance | Not Present. No specific test set data is described. |
| 3. Number & Qualifications of Experts for Ground Truth (Test Set) | Not Present. No mention of experts or ground truth establishment for performance evaluation. |
| 4. Adjudication Method (Test Set) | Not Present. |
| 5. MRMC Comparative Effectiveness Study (AI vs. without AI assistance) | Not Applicable/Not Present. This document pre-dates widespread AI clinical validation for diagnostic imaging in this context. The device is a CT scanner. |
| 6. Standalone Algorithm Performance Study | Not Applicable/Not Present. The device is a CT scanner, not an independent algorithm, in this submission. |
| 7. Type of Ground Truth Used | Not Present. |
| 8. Training Set Sample Size | Not Present. Not relevant for a hardware 510(k) submission primarily focused on substantial equivalence to a predicate device's design and technological characteristics. |
| 9. Ground Truth Establishment for Training Set | Not Present. |
In conclusion, the K060937 submission for the "Brilliance Volume" CT scanner is a typical 510(k) summary from 2006, demonstrating substantial equivalence through technological comparison and adherence to general safety and quality standards, rather than providing a detailed clinical performance study with defined acceptance criteria and proven device performance metrics. Such in-depth clinical studies and AI algorithm evaluations, as implied by your questions, became much more common and detailed in regulatory submissions in later years, especially with the rise of AI in medical devices.
§ 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.