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The SOMATOM P30 systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM P30 is a whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The provided document, a 510(k) summary for the SOMATOM P30 CT System, does not contain details about specific acceptance criteria or a study proving the device meets them, in the typical sense of a performance study for AI/CAD-like devices.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Plus 4 with Volume Zoom (K982349)) and adherence to regulatory standards for medical imaging equipment.

Therefore, many of the requested sections about specific performance studies (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment) cannot be extracted from this document, as they are not present.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not mentioned. This document does not describe a clinical performance study using a test set of patient data, as would be typical for AI/CAD devices. The focus is on hardware and software system safety and functional equivalence to an existing CT system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not mentioned. As no clinical performance study involving a test set and ground truth establishment is described, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not mentioned. No adjudication method is described as there is no test set or expert ground truth determination.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This document describes a CT scanner, not an AI or CAD device intended to assist human readers, so an MRMC study is not relevant and was not performed/described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not mentioned. This is a CT imaging system. Its "performance" is inherent in its ability to produce images, not in an algorithmic diagnostic output that would be evaluated in a standalone manner like an AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not mentioned. Ground truth in the context of clinical accuracy is not discussed here, as the submission focuses on regulatory compliance and functional equivalence, not diagnostic accuracy studies.

8. The sample size for the training set

• Not applicable / Not mentioned. The device is a CT scanner, not an AI algorithm trained on a dataset. The software performs image reconstruction and management, likely based on established algorithms and engineering, not machine learning from a "training set" of images in the typical AI sense.

9. How the ground truth for the training set was established

• Not applicable / Not mentioned. As there's no mention of a training set, there's no ground truth establishment for it.

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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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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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