Search Results

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.

Ask a specific question about this device

The LightSpeed 7.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

The LightSpeed 7.0 CT Scanner System is composed of a gantry, patient table, console, and PDU, and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. LightSpeed 7.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The provided document is a 510(k) summary for the LightSpeed 7.0 CT Scanner System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing new performance acceptance criteria and conducting specific studies to prove those criteria.

Therefore, the document does not contain a table of acceptance criteria or reported device performance in the way a clinical performance study for an AI algorithm would.

Instead, the "performance" demonstrated is the equivalence to the predicate device (LightSpeed 5.0).

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

The document does not describe a test set or data provenance in the context of a clinical performance study. The evaluation for this 510(k) is based on a comparison of technical specifications and design features with the predicate device, not on new clinical data from a test set of patients.

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

This information is not applicable to this 510(k) submission. No clinical test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set

This information is not applicable to this 510(k) submission. No clinical test set 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

This information is not applicable to this 510(k) submission. This is a CT scanner system, not an AI software intended to assist human readers, and no MRMC study is described.

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

This information is not applicable to this 510(k) submission. This is a CT scanner system, not an AI algorithm, and no standalone performance study is described.

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

This information is not applicable to this 510(k) submission. No clinical ground truth is established as part of this submission process. The "ground truth" here is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

This information is not applicable to this 510(k) submission. This device is a hardware system, not a machine learning model, and therefore does not have a training set in the AI sense.

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

This information is not applicable to this 510(k) submission for the reasons stated above.

Ask a specific question about this device

The LightSpeed 6.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

The LightSpeed 6.0 CT Scanner System is composed of a gantry, patient table, console, and PDU, and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. LightSpeed 6.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic operating principles.

This document describes a 510(k) summary for the GE Medical Systems LightSpeed 6.0 CT Scanner System. The submission focuses on demonstrating substantial equivalence to a predicate device (LightSpeed 5.0 CT Scanner System) rather than outlining specific performance metrics with acceptance criteria for a novel AI/CAD device.

Therefore, many of the requested elements for a study proving device meeting acceptance criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of regulatory submission. The focus here is on hardware and system modifications, safety, and compliance with existing standards.

However, I can extract information related to the device description and the general safety and effectiveness statement:

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

Since this is a CT scanner system and not a diagnostic AI/CAD device, the "acceptance criteria" are related to system specifications, safety features, and compliance with regulatory standards, rather than diagnostic accuracy metrics.

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

• Not applicable for this 510(k) submission. The document does not describe a clinical performance study with a test set of patient data as one would for an AI/CAD system. Instead, it focuses on engineering and regulatory compliance documentation.

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. See point 2.

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

• Not applicable. See point 2.

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 is a CT scanner system, not an AI/CAD device for radiological interpretation.

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

• Not applicable. This is a CT scanner system, not a standalone algorithm.

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

• Not applicable. The "ground truth" in this context revolves around engineering specifications, safety standards, and performance characteristics validated through system testing and compliance checks, rather than diagnostic "ground truth" for disease detection.

8. The sample size for the training set

• Not applicable. This is a CT scanner system, not an AI/CAD device that requires a training set of patient data.

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

• Not applicable. See point 8.

Ask a specific question about this device