(78 days)
This device is indicated 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. This specific model employs the use of ECG signals to specify the timing of the x-ray transmission commencement.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) summary for an ECG-Gating System for a CT scanner.
Here's what the document does include and what it lacks in relation to your request:
Information Present:
- Device Description: The ECG-Gating System is an upgrade to the Aquilion CT Scanner, TSX-101A, allowing scans to be triggered by ECG-gating signals.
- Intended Uses: To produce cross-sectional images of the human body for diagnostic purposes (e.g., spine, head injuries, tumors, blood clots, soft tissue lesions, etc.). The document states "This device employs no intended uses that are not in cleared device already found in the marketplace."
- Technological Characteristics: High-frequency x-ray controllers, x-ray detector, computer reconstruction, producing 2D black and white images. States it employs the same technological characteristics as the predicate device, "differing only in the specifics of subassembly component composition."
- Safety and Effectiveness Concerns: Designed and manufactured under Quality System Regulations (21 CFR § 820), complies with Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33), and conforms with applicable parts of IEC-60601.
- Substantial Equivalence: Based on the above, the submitter believes the upgrade is substantially equivalent to the Aquilion CT scanner.
- FDA Determination: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Information Lacking (regarding performance and studies):
- Acceptance Criteria Table: There is no table of acceptance criteria nor reported device performance against such criteria. The document focuses on regulatory compliance and substantial equivalence to a predicate device.
- Study Details: There is no mention of any specific study conducted to test the performance of the ECG-Gating System, such as details on sample size, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or ground truth types.
- Training Set Information: No information is provided regarding a training set or how ground truth for a training set was established.
Conclusion:
The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to regulatory standards for safety and manufacturing. It does not present any clinical performance data, acceptance criteria, or details of a study designed to prove the device meets specific performance criteria. This type of information is often not required for 510(k) submissions where substantial equivalence is established based on technological similarity and predicate device history, especially for an upgrade that doesn't introduce new intended uses.
§ 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.