(81 days)
The "AcQSim-Multislice-CT" is a Computed Tomography X-Ray System intended to produce 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 "AcQSim-Multislice-CT" is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 40 slices simultancously. The acquired x-ray transmission data is reconstructed by computer into images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and cquipment supports, components and accessories.
The provided text is a 510(k) summary for the "AcQSim-Multislice-CT" CT Scanner. This document confirms the device's substantial equivalence to existing predicate devices, indicating that it does not present new questions of safety or effectiveness. As such, it does not contain details about specific acceptance criteria or an analytical study with performance metrics for the device itself, nor does it describe AI-related efficacy.
The document primarily focuses on:
- Device Description and Intended Use: A whole-body CT X-ray system intended to produce images of the body by computer reconstruction of X-ray transmission data.
- Comparison to Predicate Devices: Lists "AcQSim-CT, K001088", "Mx8000 IDT, K012009", and "Mx8000 v5.0, K010817" as predicate devices.
- Safety and Effectiveness Considerations: This section vaguely states that safety is assured by adherence to GMP practices, International Standards, company software procedures, quality assurance, IEC 60601-1 standards for electrical/mechanical safety, and 21 CFR, Subchapter J for radiation safety. It does not provide quantitative acceptance criteria or study results.
- Substantial Equivalency Statement: Philips' opinion that the device is substantially equivalent to the predicate devices.
- FDA Clearance Letter: The FDA letter confirms the review of the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided document. The document is a regulatory approval summary, not a detailed technical or clinical study report. It does not include information about:
- Specific acceptance criteria (e.g., quantitative performance targets).
- Reported device performance against such criteria.
- Sample sizes for test or training sets.
- Data provenance, expert qualifications, or adjudication methods.
- MRMC studies, human-in-the-loop performance, or standalone algorithm performance.
- Ground truth types or establishment for training/test sets.
§ 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.