(45 days)
Acquisition and display of axial x-ray images of the whole body to include the head.
The Aquilion 32/64 SP is a multi-slice CT system, consisting of a gantry, patient couch and console. The system generates uop to 128 axial images ower second using a selectable slice-thickness multi-row detector.
The provided text for K080211 is a 510(k) premarket notification for a modification to an existing CT system. It does not contain information about acceptance criteria, device performance results, or a study specifically designed to demonstrate the device meets acceptance criteria.
The document primarily focuses on establishing "substantial equivalence" of the modified device (Aquilion 32/64 SP CT System) to a predicate device (TSX-101A/I Aquilion 64 SP CT System) based on similar technological characteristics and adherence to safety standards.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth.
The document only states:
- Device Description: "The Aquilion 32/64 SP is a multi-slice CT system, consisting of a gantry, patient couch and console. The system generates uop to 128 axial images ower second using a selectable slice-thickness multi-row detector."
- Intended Use: "This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities gastro intestinal lesions , abdominal and levic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, ass intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the market place."
- Safety and Effectiveness Concerns: "This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-44. -Medical Device Safety standards."
The FDA's letter (Section 510(k) premarket notification) confirms substantial equivalence, which means they found the device to be as safe and effective as a legally marketed predicate device. However, this determination is based on the information provided in the submission, which in this case, does not detail a specific performance study with acceptance criteria in the format requested.
§ 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.