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

The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology.

The system allows imaging of obese patients, up to and including the morbidly obese population (BMI > 40).

When used in the LightSpeed RT Pro16 configuration:

The system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

The LightSpeed Xtra CT Scanner System is composed of a gantry, patient table, operator console, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

The system generates images through the computer reconstruction of data acquired at different angles of the same axial plane. The gantry can rotate at up to 0.5 seconds per rotation, and can acquire up to 16 slices of data with a maximum total coverage of 20mm in the axial direction. The system may be operated in both axial and helical scan modes.

The system features an 80cm diameter wide bore to accommodate large patients and radiation therapy planning immobilization devices, to allow easy access during interventional procedures, and for ease of patient positioning.

The LightSpeed Xtra system is also available as the LightSpeed RT ProJ6, which features a unique accessory package designed to assist planning of radiation therapy procedures.

The provided text is a 510(k) summary for the GE LightSpeed Xtra CT Scanner System. This document is primarily focused on demonstrating substantial equivalence to a predicate device and discussing the device's technical specifications and intended use. It does not contain information about specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in terms of clinical accuracy or diagnostic efficacy.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for clinical outcomes or diagnostic accuracy. It focuses on technical specifications and safety standards.
2. Sample size used for the test set and the data provenance: No test set data or provenance is mentioned for device performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a clinical test set is not described.
4. Adjudication method for the test set: No test set adjudication method is mentioned.
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 MRMC study, AI component, or human improvement metrics are discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed as this is a CT scanner, not an AI diagnostic algorithm.
7. The type of ground truth used: No ground truth for clinical performance or diagnostic accuracy is described.
8. The sample size for the training set: No training set information is provided.
9. How the ground truth for the training set was established: No training set information is provided.

The document states:

• "LightSpeed Xtra is an evolutionary modification to the LightSpeed 5.0 scanner (K030420), does not result in any new potential safety risks, and performs as well as or better than devices currently on the market." This is a general claim of equivalence and performance, not a report of specific acceptance criteria met.
• "LightSpeed Xtra will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33, as well as the safety requirements of UL 60601-1, and IEC 60601-1 and associated collateral and particular standards." These are safety and technical compliance standards, not clinical performance acceptance criteria.

To obtain the information you are requesting, you would typically need a clinical study report or performance evaluation document, which is not included in this 510(k) summary.

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The StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

The StarSpeed Series CT Scanner Systems are composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system.

The StarSpeed Series 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 2601-1. 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 StarSpeed Series CT Scanner Systems. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any specific study detailing such criteria or performance.

The document primarily focuses on establishing substantial equivalence to previously marketed devices (LightSpeed CT Scanners) through evolutionary modifications. It lists the device description, indications for use, comparison with predicate devices, and conclusions regarding safety and equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided input. The document is essentially a regulatory filing establishing equivalence, not a detailed performance study report.

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The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation and diagnosis of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This can also assist in radiotherapy planning.

The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

The Discovery LS CT-PET System is a combination of the Advance NXi PET Scanner (K003849) and the LightSpeed CT Scanner (K000300, K002978). In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for nonuniform attenuation of the PET images and it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery LS has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently reqistered anatomical and functional information via an integrated user interface.

The provided 510(k) summary for the GE Discovery LS System does not contain specific acceptance criteria or a detailed study description with performance metrics in numerical form.

Instead, it states that "Discovery LS bench and clinical data demonstrate the ability of Discovery LS to image injected radiopharmaceuticals for the assessment of metabolic (molecular) and physiologic functions of the body and the ability of Discovery LS to to use integrated CT and PET images to localize metabolic activity and FDG uptake in the patient anatomy." This is a general statement rather than a detailed report of a study designed to meet pre-defined acceptance criteria with quantifiable results.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, MRMC studies, or standalone performance for this specific submission based on the provided text.

This 510(k) submission focuses on demonstrating substantial equivalence to a previously cleared device (GE CT-PET System K010641) for a revised intended use, rather than presenting a de novo study with explicit performance goals and outcomes.

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The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

The LightSpeed 4.0 CT Scanner System is composed of a gantry, patient table, console, computer, and associated accessories.

Materials: Materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978) are compliant with UL 2601-1, IEC 60061-1, and 21CFR Subchapter J.

Design: The system is designed to be a head and whole body CT scanner utilizing a new solid state detector, an intuitive Operator Console, and the same tube and similar features to the LightSpeed 3.0 CT Scanner System (K002978), but now capable of imaging 16 slices per rotation. The system will use a new multi-slice detector having thinner detector elements.

The provided text describes a 510(k) summary for the LightSpeed 4.0 CT Scanner System. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices. This means that the manufacturer is asserting their new device is as safe and effective as a predicate device, rather than providing new performance data against specific, novel acceptance criteria.

Therefore, many of the requested items in your prompt cannot be answered directly from the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "criteria" are implied to be "as good as or better than" currently marketed devices and compliance with relevant standards.
• Reported Device Performance: No specific performance metrics (e.g., spatial resolution, contrast-to-noise ratio, dose efficiency) are provided in the summary. The "performance" is generally described as being "as well as or better than devices currently on the market."

2. Sample size used for the test set and data provenance:

• Not Applicable. The document does not describe a clinical study with a test set of human subjects or data. It relies on a comparison to predicate devices and adherence to engineering/safety standards.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• Not Applicable. No ground truth establishment is described, as there's no clinical test set for performance comparison.

4. Adjudication method for the test set:

• Not Applicable. No test set or adjudication process 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:

• No. This document is for a CT scanner system, not an AI or CAD (Computer-Aided Detection/Diagnosis) device. Therefore, an MRMC study with AI assistance is not relevant or mentioned.

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

• No. This is a hardware device (CT scanner), not a standalone algorithm.

7. The type of ground truth used:

• Not Applicable. No clinical ground truth is described. The basis for safety and effectiveness is substantial equivalence to a predicate device and compliance with standards.

8. The sample size for the training set:

• Not Applicable. This is a hardware device; there is no mention of a "training set" in the context of an algorithm.

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

• Not Applicable. As there's no training set, there's no ground truth establishment for one.

Summary of the "Study" (or rather, the basis for clearance):

The "study" or basis for clearance is not a traditional clinical trial with acceptance criteria for device performance. Instead, it is a demonstration of substantial equivalence through:

• Design comparison: Stating the LightSpeed 4.0 CT Scanner System is "of comparable type and substantially equivalent" to currently marketed systems, sharing features like an intuitive Operator Console and the same tube as its predecessor (LightSpeed 3.0 CT Scanner System K002978).
• Material comparison: Stating materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978).
• Compliance with standards: Adherence to UL 2601-1, IEC 60061-1, IEC 60601-1, 21CFR Subchapter J, and the X-ray requirements of 21CFR1020.30 and 1020.33. These standards, rather than direct performance metrics against a clinical dataset, form the "acceptance criteria" and the "proof" of meeting them is the attestation of compliance.
• Risk Management: Identification and control of potential electrical, mechanical, and radiation hazards through system verification and validation, and adherence to industry/international standards.

In essence, the "study" is a compliance and comparison exercise with a predicate device and established standards, rather than an independent performance study against specific clinical criteria.

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