Search Results

The Optima CT660 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 transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The 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 Optima CT660 and its associated configurations/packages is a multi-slice CT scanner system consisting of a gantry, patient table, operator console, power distribution unit (PDU), associated accessories, and connections/interfaces to accessories. The system includes image acquisition hardware, image acquisition & reconstruction software, associated accessories, and connections/interfaces to accessories. ASiR advanced reconstruction technology is also an option on this product and was cleared in K093581.

The Optima CT660 CT system is intended to be a head and whole body CT system incorporating the same basic fundamental operating principles and the same indications for use as the predicate device. 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 21 CFR Subchapter J. It has been developed under the same GE quality system and has completed all design controls, including risk management, verification and validation.

Here's an analysis of the provided text regarding the Optima CT660, addressing your questions about acceptance criteria and study details.

Important Note: The provided document is a 510(k) Premarket Notification Summary for a CT Scanner. It's a regulatory submission to demonstrate substantial equivalence to a predicate device, not typically a comprehensive clinical study report for a novel AI algorithm or diagnostic tool. Therefore, many of your questions, especially those related to specific performance metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication, or MRMC studies, are not directly addressed in this type of document because they are not usually required for a substantial equivalence claim for a CT scanner itself.

The focus here is on demonstrating that the new device meets established safety and performance standards equivalent to existing devices.

1. A table of acceptance criteria and the reported device performance

Since this is a CT scanner and not a device that produces a diagnostic output that would have metrics like sensitivity or specificity, the "acceptance criteria" are related to compliance with regulations and performance equivalence to a predicate device.

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

This document does not describe a test set or data provenance in the context of diagnostic performance studies. The "testing" mentioned refers to engineering verification and validation against technical specifications and regulatory standards, not clinical data performance.

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. This type of information is not present as a clinical diagnostic performance study with expert-adjudicated ground truth was not performed or detailed here.

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

Not applicable. No diagnostic test set or adjudication method 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 applicable. The Optima CT660 is a CT scanner, not an AI-assisted diagnostic tool for interpretation. There is a mention of "ASiR advanced reconstruction technology" as an option which was cleared in K093581, but no details of an MRMC study for ASiR are provided here.

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

Not applicable. No standalone algorithm performance is described.

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

Not applicable. For a CT scanner, the "ground truth" would relate to its ability to accurately acquire and reconstruct images according to physical specifications, not clinical diagnostic outcomes. The document indicates verification against specifications and comparison to the predicate device.

8. The sample size for the training set

Not applicable. This document is for a CT scanner, not a machine learning model developed with training data.

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

Not applicable. No training set is involved for this submission type.

Summary of the document's relevance to your questions:

This 510(k) summary focuses on demonstrating that the Optima CT660 (a new CT scanner) is substantially equivalent to a legally marketed predicate CT scanner. This means it has the same indications for use, employs the same fundamental technology, and meets the same safety and performance standards. It details engineering verification, validation, and compliance with regulations rather than clinical performance studies typically associated with AI/CAD devices, which would involve test sets, expert ground truth, and specific performance metrics.

Ask a specific question about this device