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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 ECG-Gating System is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265, K990134]. This upgrade will allow scans to be triggered by ECG-gating signals.

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.

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The HiSpeed NX/i CT system and HiSpeed options are indicated for head and whole body x-ray computed tomography applications.

The HiSpeed NX/i CT system and HiSpeed options consist of a gantry, patient support, operator console, computer and associated accessories.

The provided text is a 510(k) summary for the GE HiSpeed NX/i CT scanner system, indicating that the device is substantially equivalent to previously marketed CT systems. However, this document does not contain the specific acceptance criteria or a study detailing the device's performance against such criteria. The document explicitly states that it does not result in new potential safety risks and performs as well as, or better than devices currently on the market, but it doesn't provide concrete metrics or a study report with performance data.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information directly from the provided text. This document is a regulatory submission for market clearance based on substantial equivalence, not a detailed performance study report.

In summary, the provided document (K991716) does not contain the information required to answer the prompt regarding acceptance criteria and performance study details.

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This device is designed to produce cross-sectional images of a human body by reconstruction of xray 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 extremittestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration.

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

The Multislice kit is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265]. This upgrade will allow for the collection of multiple axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high resolution slices will maintaining the speed required to reduce anatomical motion artifacts.

I'm sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) premarket notification summary for an upgrade kit to a CT scanner, focusing on technological characteristics, safety and effectiveness concerns, and substantial equivalence to predicate devices. It does not contain details regarding a clinical study or performance data with acceptance criteria.

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