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The GE LightSpeed 7.2 Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The GE LightSpeed 7.2 CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The GE LightSpeed 7.2 CT Scanner System is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. It is an evolutionary modification to the LightSpeed 7.1 (K061817). It is developed from the hardware platform of the 64 slice LightSpeed 7.1 system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.

The GE LightSpeed 7.2 CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

The provided text is a 510(k) summary for the GE LightSpeed 7.2 CT Scanner System. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for AI/software-based performance evaluation.

CT scanners, like the GE LightSpeed 7.2, are generally evaluated for performance through a series of technical specifications andphantom studies to ensure image quality, dose, and other physical parameters meet established standards. These standards are typically defined by regulatory bodies (like the FDA, IEC, UL) and industry best practices. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new efficacy or performance metrics for each iteration, unless there are significant changes that could impact safety or effectiveness.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This detailed performance data against specific acceptance criteria for a new AI/software feature is not present. The document focuses on regulatory compliance and substantial equivalence to existing CT scanners.
• Sample sizes used for the test set and the data provenance: No such data is provided as there isn't a "test set" in the context of an AI performance evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multicase (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding device evaluation:

The document states that the GE LightSpeed 7.2 CT Scanner System undergoes:

• System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements.
• Adherence and certification to industry and international standards (e.g., UL 60601-1, IEC 60601-1, and associated collateral and particular standards, 21CFR Subchapter J, 21CFR1020.30 and 1020.33 for X-ray requirements).
• Risk management (hazard analysis) to identify and control potential electrical, mechanical, and radiation hazards.
• Compliance with Quality System Regulations of 21CFR820.

The conclusion is that the device is an "evolutionary modification" and "does not result in any new potential safety risks and performs as well as or better than devices currently on the market," and is considered substantially equivalent to predicate devices. This indicates that its performance is presumed to meet the same established safety and effectiveness levels as the predicate devices, which would have undergone their own technical performance evaluations at the time of their clearance.

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The LightSpeed 7.1 CT Scanner System is indicated for head and whole body Xray Computed Tomography applications.

The LightSpeed 7.1 CT Scanner System is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The LightSpeed 7.1 Scanner System is an evolutionary modification to LightSpeed 7.0 (K00372) It is developed from the hardware platform of LightSpeed 7.0 32/64 slice system by adding new application features that involve changes in software, firmware, recon and scan mode. The LightSpeed 7.1 Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.

The provided text is a 510(k) summary for the GE Healthcare LightSpeed 7.1 CT Scanner System. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, the typical information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this type of submission.

Here's a breakdown of why this information is missing and what the document does address:

• Type of Device: The LightSpeed 7.1 CT Scanner System is a hardware Computed Tomography (CT) scanner with software modifications. It is not an AI algorithm or a diagnostic assay where performance metrics like sensitivity, specificity, or AUC would be paramount.
• Regulatory Pathway: The 510(k) pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. The primary goal is to show that the new device has the same intended use, fundamental technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Focus of the Document: The document emphasizes:
  • The LightSpeed 7.1 is an "evolutionary modification" of the LightSpeed 7.0 system (K040372).
  • Changes involve "new application features that involve changes in software, firmware, recon and scan mode."
  • It uses "the same materials and operating principle" as the predicate.
  • It has "identical indications for use" (head and whole body X-ray Computed Tomography applications).
  • It complies with the same electrical, radiation, and safety standards (e.g., UL 60601-1, IEC 60601-1, 21CFR1020.30, 1020.33).
  • Risk management (hazard analysis) was performed, and controls are in place.
  • "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements" is mentioned, but specific performance criteria and the study results demonstrating adherence to them are not detailed in this public summary. These would typically be internal GE documentation used to support the substantial equivalence claim, rather than being part of the 510(k) summary itself.

In summary, none of the specific "acceptance criteria" or "study details" you requested for performance evaluation of a diagnostic or AI device are present in this 510(k) summary because it's a submission for an updated CT scanner, focusing on substantial equivalence to a predicate, not novel performance claims.

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The SOMATOM P45 is intended to produce cross-sectional images of the body by The SOMA TOM 145 13 medical vary ... at different angels or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulting from the continuous rotation of detectors and xray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM P45 is a whole body X-ray computed tomography system, which I he Slement SOMATON 1-19-15 a wills and functions and functions according to the fan assisted teatures two continuously routing is a command-based program used for paint management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The provided document is a 510(k) summary for the Siemens SOMATOM Project P45, a computed tomography (CT) system. The document focuses on establishing substantial equivalence to predicate devices and outlines general safety and effectiveness concerns.

Crucially, this document does NOT contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI.

The information provided describes the device's classification, general indications for use (producing cross-sectional images), and adherence to safety standards and risk management. It confirms FDA clearance based on substantial equivalence to existing CT systems.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a clinical study report, a performance validation study, or a more detailed technical specification.

Here's a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on substantial equivalence to predicate devices for its classification as a CT system, not on specific performance metrics.
2. Sample size used for the test set and the data provenance: Not present. No specific test set for performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No performance study is described.
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: Not present. This device is a CT scanner, not an AI-assisted diagnostic tool. An AI component is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is a CT scanner, not an algorithm, and no standalone performance testing for diagnostic capabilities is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present. No performance study is described.
8. The sample size for the training set: Not present. This device is a CT scanner, not an AI model requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not present. This device is a CT scanner, not an AI model, and no training set is relevant in this context.

In summary, the provided 510(k) document for the SOMATOM Project P45 focuses on regulatory clearance for a general-purpose CT system based on substantial equivalence, and does not contain the detailed performance study information you are seeking.

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