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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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The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is indicated for head and whole body x-ray computed tomography applications.

The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems consists of a gantry, patient table, console, computer and associated accessories.

The provided text is a 510(k) summary for the GE Medical Systems HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems. This document is a premarket notification to the FDA for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

Based on the provided text, the following information can be extracted regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria and a detailed table of device performance against those criteria in the way a clinical study report would. Instead, the submission relies on demonstrating substantial equivalence to existing, legally marketed Computed Tomography (CT) X-ray Systems.

• Acceptance Criterion (Implicit): Substantial equivalence to currently marketed Computed Tomography X-ray Systems regarding design, material composition, energy source, radiation characteristics, and safety.
• Reported Device Performance (Implicit): The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems perform "as well as or better than devices currently on the market" and do not introduce "any new potential safety risks." This is a qualitative statement of performance relative to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective or prospective) for a performance study. The evaluation appears to be based on system verification and validation to specifications, rather than a clinical trial with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The document does not describe a test set or ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a test set or an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document does not indicate that an MRMC comparative effectiveness study was performed. The focus is on demonstrating substantial equivalence to existing devices, not on comparing reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

The device described is a CT scanner system, not an AI algorithm. Therefore, a standalone algorithm-only performance study is not relevant in this context. The evaluation is for the entire hardware and software system.

7. The Type of Ground Truth Used:

Not applicable. The document does not describe a performance study involving ground truth derived from clinical data (like pathology or outcomes data). The "ground truth" for the substantial equivalence claim is the performance and safety profile of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This document describes a CT imaging system, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, the device is a CT imaging system, not an AI model.

In summary, this 510(k) submission is for a new generation of CT scanners demonstrating substantial equivalence to previously cleared devices. It relies on internal verification and validation against specifications and adherence to standards rather than detailed clinical performance studies with specific acceptance criteria, ground truth, and expert evaluation to prove performance in the context of advanced diagnostic algorithms.

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The SOMATOM Plus 4 CT Scanner is intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

• The axial planes resulted from the continuous rotation of detectors and X-ray tube and the simultaneous translation of the patient.

The SOMATOM Plus 4 with Somaris 4/B30 software is a whole body computed tomography X-ray scanner, which features a continuously rotating tube-detector system and functions according to the fan beam principle.

The provided text is a 510(k) Summary for the Siemens SOMATOM Plus 4 Computed Tomography (CT) Scanner with Somaris 4/B30 Software, submitted in 1996. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

*However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot populate the table or answer the specific questions about performance studies. The 510(k) summary focuses on demonstrating equivalence to predicate devices based on design and technological characteristics, not on presenting detailed performance data from a specific study and acceptance criteria.

Key takeaway from the document regarding performance:

• Improved Low Contrast Resolution and Reduced Noise: The document states that the addition of an optional solid-state detector, which has a higher conversion efficiency than the previous xenon detector, "improves low contrast resolution and reduces image noise." This is a qualitative statement about performance improvement, but no specific metrics, acceptance criteria, or study data are provided to quantify this improvement.

In summary, based only on the provided text, the requested information about acceptance criteria and detailed study data is not available.

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HiSpeed CT/i with Performix Tube and Warp Scan Option is intended to provide 0.8 second 360-degree helical or axial scans as well as increase the maximum tube heat capacity and provides additional mA settings over our existing system.

The option is a software control key for the HiSpeed system that increases the allowable speed (Warp Scan), for single rotation to 0.8 seconds for axial and helical scanning as well as 0.5 second rotation for partial scan. The Performix tube provides an additional tube option for use on the HiSpeed Gantry. It is a metal cased tube that has a heat capacity of 6.3MHU. For HiSpeed CT/i systems the maximum available power increases. The new tube takes advantage of power capabilities of the power distribution unit that is currently provided with the system. The increase in available power will not require a change in hardware.

The provided text is a summary of safety and effectiveness for a medical device modification (HiSpeed CT/i with Performix Tube and Warp Scan Option). It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared device (HiSpeed CT/i, K940606).

However, the document does NOT contain information about acceptance criteria, specific device performance studies to meet those criteria, sample sizes, expert involvement, ground truth establishment, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot populate the requested table or answer the specific questions directly from the provided text. The document focuses on describing the changes and asserting safety and equivalence based on adherence to standards and the nature of the modifications, rather than presenting a formal study with detailed performance metrics against acceptance criteria.

The information provided is more aligned with a premarket notification (510(k)) where the primary argument is substantial equivalence, rather than a detailed clinical trial report or a performance validation study against specific quantitative acceptance criteria.

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The CT ProSpeed CT/i is indicated for head and whole body xray computed tomography applications. It provides axial, helical and scout imaging.

The device is an x-ray computed tomography scanner consisting of a gantry, patient table, console, computer, and associated accessories.

This document is a 510(k) summary for a CT scanner (CT ProSpeed CT/i). It focuses on demonstrating substantial equivalence to previously marketed devices and ensuring safety. It does not contain information on the acceptance criteria, study design, or performance metrics typically associated with AI/algorithm-driven devices. Therefore, I cannot extract the requested information from the provided text.

Specifically, the document from 1996 describes a computed tomography (CT) scanner, a hardware device for medical imaging, not an AI or algorithm-driven software device. The acceptance criteria and performance data requested (e.g., sensitivity, specificity, MRMC studies, ground truth establishment) are relevant to software algorithms, particularly those involved in image analysis or diagnosis. These types of studies were not typically performed or reported in 510(k) submissions for hardware imaging devices like CT scanners in 1996.

Therefore, the requested information cannot be filled from the provided text.

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