(34 days)
The Philips MX 16-slice CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating x-ray tube and detector array with multislice capability up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.
The MX 16-slice CT System, phase II is a Whole Body Computed Tomography X-Rav 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.
The provided document is a 510(k) summary for the Philips MX 16-slice CT System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, performance studies (other than general quality assurance), sample sizes for testing or training, expert ground truth establishment, or any information about AI assistance or standalone algorithm performance.
Therefore, I cannot fulfill your request for this input based on the provided text. The document focuses on regulatory compliance and equivalence to an existing device, rather than detailed performance study results.
Here's an explanation of why the requested information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance: The document states that "meeting the specifications and functional requirements is demonstrated via testing," but it does not specify what those specifications or functional requirements are, nor does it provide any quantitative performance data.
- Sample Size for Test Set and Data Provenance: This information is completely absent.
- Number of Experts and Qualifications: This information is not mentioned.
- Adjudication Method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication of such a study. The product is a CT scanner, not an AI-powered diagnostic tool.
- Standalone Performance (Algorithm Only): The device is a physical CT scanner, not an AI algorithm, so this concept does not apply in the context of this document.
- Type of Ground Truth Used: Not applicable or mentioned, as there are no diagnostic AI algorithms being evaluated.
- Sample Size for Training Set: Not applicable, as there's no mention of an AI model or training.
- How Ground Truth for Training Set Was Established: Not applicable.
The submission focuses on substantiating that the MX 16-slice CT System is substantially equivalent to a previously cleared device (Brilliance CT 16-slice, K012009) by demonstrating similar technological characteristics and adherence to general safety standards (GMP, ISO, IEC, 21 CFR Subchapter J). This type of submission generally does not require detailed clinical performance studies beyond what was established for the predicate device, unless significant changes impacting safety or effectiveness are introduced.
§ 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.