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The HiSpeed X/i Smart Gantry Option CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

The HiSpeed X/i Smart Gantry Option CT Scanner System is composed of a gantry, shared patient table, console, computer, and associated accessories. The system is designed to be a head and whole body CT scanner utilizing a solid state detector, an intuitive Operator Console, and the same tube and similar features to the HiSpeed Family of CT Systems (K980169), but now the gantry is on a dolly that travels on rails to provide the capability of scanning by gantry travel instead of cradle travel. The stationary table/cradle to be used is a table that will be shared with a Linear Accelerator. The table/cradle will remain stationary while CT scanning is in progress.

The provided text is a 510(k) Summary for a medical device called the "HiSpeed X/i Smart Gantry Option CT Scanner System." This document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It's important to note that a 510(k) summary for a CT scanner primarily focuses on demonstrating substantial equivalence in design, materials, and performance characteristics (like radiation output and image quality parameters) compared to a predicate device, and not on diagnostic acceptance criteria based on clinical outcomes or expert consensus for disease detection, which would be typical for an AI/CADe device.

Therefore, many of the requested items (like expert consensus, MRMC studies, standalone performance with metrics like sensitivity/specificity, and training set information) are not applicable to this type of device and, consequently, not found in the provided document. The acceptance criteria here would relate to engineering, safety, and performance specifications of the CT scanner hardware.

Based on the provided text, here is the information that can be extracted or inferred:

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

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

• Not applicable / Not mentioned. This document is for a CT scanner's hardware characteristics, not a diagnostic algorithm. There is no "test set" of patient data in the context of clinical performance metrics like sensitivity/specificity for disease detection. The performance testing would relate to engineering specifications and safety, which do not typically involve patient data sets in this way.

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 / Not mentioned. Ground truth by experts is not established for this type of device submission.

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

• Not applicable / Not mentioned. Adjudication is not relevant for this type of hardware device submission.

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. This is a CT scanner, not an AI or CADe device. No MRMC study for improved human reader performance would be conducted or reported here.

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

• Not applicable. There is no algorithm to assess independently in this context.

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

• Not applicable. The "ground truth" for a CT scanner would be its mechanical, electrical, and radiation output specifications meeting engineering standards and regulatory limits, as well as its ability to produce images according to technical specifications (e.g., spatial resolution, contrast resolution, dose). This is demonstrated through engineering verification and validation testing, not clinical ground truth in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

• Not applicable. As above, no training set for an AI algorithm.

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The CT/e Computed Tomography system is intended for head and whole body x-ray computed tomography applications.

The CT/e Computed Tomography system consist of a gantry, patient support, operator console, computer and associated accessories.

The provided text is a 510(k) Summary of Safety and Effectiveness for the GE CT/e Computed Tomography scanner system. This document is focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria for a new, novel AI-enabled device.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment are not present in this type of submission. This document predates the widespread use of AI in medical imaging devices and the specific regulatory guidance around its validation.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an ordinary 510(k) submission for a conventional CT scanner. The submission's goal is to demonstrate substantial equivalence, not to meet pre-defined performance metrics for a novel algorithm.

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

Not applicable. This is not a study validating an AI algorithm with a test set of images. The "test" here refers to system verification and validation against specifications and regulatory requirements, not performance on a clinical image dataset.

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

Not applicable. Ground truth establishment with experts is typical for AI/ML device validation. This document describes a conventional CT scanner submission.

4. Adjudication method for the test set

Not applicable.

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. This is not an AI-enabled device and therefore no MRMC study was performed in relation to AI assistance.

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

Not applicable.

7. The type of ground truth used

Not applicable in the context of validating performance on a clinical dataset. The "ground truth" for this conventional device would be its adherence to established engineering specifications, regulatory standards (e.g., 21 CFR Subchapter J, IEC 60601-1), and the performance of the predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of what is present and relevant in the document:

• Device Type: Conventional CT scanner (CT/e Computed Tomography scanner system)
• Regulatory Pathway: 510(k) clearance, demonstrating "substantial equivalence."
• Predicate Device: HiSpeed LX/i, FX/i and DX/i (K980169)
• Performance (as stated for substantial equivalence):
  • "The CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed computed tomography systems that comply with the same or equivalent standards and have the same intended uses."
  • "It is the opinion of GE Medical Systems that the CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed head and whole body x-ray computed tomography systems with respect to design, material composition, energy source and radiation characteristics."
  • "It will comply with the x-ray performance standards of 21 CFR as well as the safety requirements of the IEC 60601-1 series of standards."
  • "System verification and validation to insure performance to specifications, regulatory requirements and user requirements."
  • "Adherence to Industry and International Standards (UL/IEC/CSA)"
  • "Use of the CT/e Computed Tomography system does not result in any new potential safety risks and performs as well as, or better than devices currently on the market."

In essence, this document demonstrates that the CT/e system meets its "acceptance criteria" by being substantially equivalent to existing, legally marketed CT systems and by complying with relevant safety and performance standards for such devices. The "study" for this type of submission is the comprehensive engineering design, manufacturing adherence, and verification/validation activities typical for conventional medical devices.

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The HiSpeed NX/i CT system and HiSpeed options are indicated for head and whole body x-ray computed tomography applications.

The HiSpeed NX/i CT system and HiSpeed options consist of a gantry, patient support, operator console, computer and associated accessories.

The provided text is a 510(k) summary for the GE HiSpeed NX/i CT scanner system, indicating that the device is substantially equivalent to previously marketed CT systems. However, this document does not contain the specific acceptance criteria or a study detailing the device's performance against such criteria. The document explicitly states that it does not result in new potential safety risks and performs as well as, or better than devices currently on the market, but it doesn't provide concrete metrics or a study report with performance data.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information directly from the provided text. This document is a regulatory submission for market clearance based on substantial equivalence, not a detailed performance study report.

In summary, the provided document (K991716) does not contain the information required to answer the prompt regarding acceptance criteria and performance study details.

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