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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 NL3000 CereTom is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm field of view, primarily head and neck.

The NL3000 CereTom is a high resolution, 8 row, 32 cm bore, 25cm field of view, Computed Tomography System. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, 3264-element solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, touch screen LCD display, power system, brushless DC servo drive system (disk rotation), and stepper drive system (translation). The power system consists of dry sealed batteries which provide system power while unplugged from the charging outlet. When plugged into an outlet the system charges the batteries with a line power drain of less than 1300 watts. The work station consists of a Sony Vaio laptop computer. The workstation software consists primarily of a certified off-the-shelf CT viewing system from a third party vendor. In addition the system has the necessary safety features such as emergency stop switch, x-ray indicators, interlocks, patient alignment laser, and 110 percent x-ray timer. It requires very little x-ray power in comparison to large bore systems to obtain equivalent CT image quality. The gantry has retractable 100mm diameter rotating caster wheels so the system can be moved easily to different locations.

The provided text is a 510(k) summary for the NeuroLogica NL3000 CereTom Computed Tomography System. It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics. Therefore, much of the requested information regarding acceptance criteria, study details, and performance statistics is not available in the provided text.

Specifically, the document primarily addresses:

• Device description and intended use.
• Comparison of technological characteristics with predicate devices (Philips Tomoscan M/EG, GE LightSpeed Ultra CT, Siemens SOMATOM Plus 4).
• General safety and effectiveness concerns, stating adherence to regulations and standards (e.g., 21 CFR Part 1020, UL60601-1, IEC 60601-1, EN 60601-1).
• A conclusion of substantial equivalence to the predicate devices based on design, material, functionality, and technology.

There is no information about a specific study with clearly defined acceptance criteria, reported device performance metrics against those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on training set size and ground truth establishment in the provided text.

The document is a submission for regulatory clearance based on substantial equivalence, which often means demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical study results with detailed performance metrics.

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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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