(39 days)
The GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16/ LightSpeed Xtra) 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), and Gated acquisitions for all ages. 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 RT18 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT18/ LightSpeed Xtra) is indicated for head, whole body, and vascular X-ray Computed Tomography applications.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
The system is capable of assisting with minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of Bariatrics patients, up to and including the morbidly obese population (BMI > 40).
When used in the LightSpeed RT16 configuration, the system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
The GE LightSpeed RT16 / LightSpeed Xtra V2 (aka LightSpeed RT16 /LightSpeed Xtra CT) 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 and planes of the rotating gantry. The gantry can rotate at up to 0.5 seconds (at full) per rotation, and can acquire up to 16 slices of data per rotation with a maximum total coverage of 20mm in the axial direction. The system can be operated in Axial, Cine, Helical, Fluoro and Gated acquisition modes.
The GE LightSpeed RT16 / LightSpeed Xtra V2 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.
This 510(k) summary describes a GE LightSpeed RT16 / LightSpeed Xtra V2 CT Scanner System. The submission focuses on substantial equivalence to a predicate device and safety considerations rather than demonstrating performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in the provided text.
Specifically:
- No detailed acceptance criteria with performance metrics are provided. The document outlines the device's technical specifications and intended use but does not list specific quantitative performance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) that a study would then prove the device meets.
- No specific study is described that tests the device's diagnostic performance against established acceptance criteria. The document mentions "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements" and "Adherence and certification to industry and international standards." However, these refer to engineering and regulatory compliance, not a clinical study demonstrating diagnostic effectiveness.
Therefore, the following points will indicate that the information is "Not Available in the provided text" where the document does not contain the answer.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available in the provided text | Not Available in the provided text |
Explanation: The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or report specific performance metrics for the device against such criteria. It emphasizes substantial equivalence to a predicate device and compliance with safety and regulatory standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not Available in the provided text
- Data Provenance: Not Available in the provided text
Explanation: As no study demonstrating diagnostic performance is described, information on sample size and data provenance for a test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not Available in the provided text
- Qualifications of Experts: Not Available in the provided text
Explanation: Without a described study involving ground truth establishment, this information is not available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not Available in the provided text
Explanation: This information is not available as no study involving expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study Done: No.
- Effect Size: Not Applicable.
Explanation: The document describes a CT scanner system, not an AI-powered diagnostic device or a system designed to assist human readers in a diagnostic task that would typically involve an MRMC study assessing AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study Done: No.
Explanation: This device is a CT scanner, an imaging modality, not an algorithm, so a standalone algorithm performance study is not applicable in the context described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not Available in the provided text
Explanation: No study requiring the establishment of diagnostic ground truth is described.
8. The sample size for the training set:
- Sample Size: Not Available in the provided text
Explanation: As this is primarily a hardware submission for a CT scanner system, and not an AI/algorithm-focused submission, there is no mention of a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not Available in the provided text
Explanation: No training set is mentioned in the document.
Summary of the Document's Approach:
The 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (GE LightSpeed Xtra CT Scanner System K060052) and compliance with regulatory and safety standards for the manufacturing and operation of the CT scanner. It highlights:
- The new device is an "evolutionary modification" to an existing platform.
- It shares "virtually the same materials and identical operating principle" as the predicate.
- It has "similar indications for use."
- It complies with X-ray requirements (21CFR1020.30 and 1020.33) and safety standards (UL 60601-1, IEC 60601-1).
- Risk management and verification/validation ensure performance to specifications and user requirements.
This type of submission typically does not involve new clinical studies to establish diagnostic accuracy against specific human-interpretable acceptance criteria, but rather demonstrates that the updated device performs equivalently and safely to its predicate.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.