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The intended use and the indications for use of the GLORY mammography system (Screening and diagnostic breast radiography) are unchanged.

Radiography of the breast
Preoperative wire localization and stereotactic biopsy procedures

The Advanced Automatic Detector Selection (AADS) option is used with the automatic exposure control of the GLORY mammography system. With the AADS option, the legally marketed GLORY system can determine exposure parameters automatically from a detector located beneath the densest breast tissue.

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request. The document describes an "Advanced Automatic Detector Selection (AADS) option for the GLORY Mammography System" and focuses on its substantial equivalence to a predicate device, rather than providing a detailed performance study with acceptance criteria.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Comment: The document does not define specific quantitative acceptance criteria (e.g., sensitivity, specificity, image quality metrics) for the AADS option's performance. Instead, it makes a qualitative statement about its safety and effectiveness relative to the predicate device.

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

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided. The document focuses on regulatory compliance and substantial equivalence rather than a clinical performance study.

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

• This information is not provided as the document does not describe a performance study with a test set requiring ground truth established by experts.

4. Adjudication method for the test set

• Not applicable as no performance study with a 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

• No MRMC comparative effectiveness study is mentioned. The device is an "Advanced Automatic Detector Selection" option, implying an automated function during image acquisition, not necessarily an AI-assisted interpretation tool for human readers.

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

• The device is an "option" for an existing mammography system, designed to "determine exposure parameters automatically from a detector located beneath the densest breast tissue." This implies a standalone algorithmic function within the system for exposure control. However, the document does not contain data to describe its standalone performance in terms of specific metrics. It's an enhancement to the existing automatic exposure control.

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

• Not applicable as no performance study requiring "ground truth" to evaluate diagnostic accuracy is described. The device's function is exposure control, not diagnosis.

8. The sample size for the training set

• Not applicable. The document describes a device option, not a machine learning model that would typically have a training set.

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

• Not applicable. As above, this device is not presented as a machine learning model requiring a training set with ground truth.

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The Volumax is used for whole body computed tomography.

Whole body computerized tomography.

The Volumax is a continuous rotation CT scanner consisting of a gantry, patient table, operator station and accessories. Its main characteristics are:

• Continuous rotation and Helix (spiral) scanning. .
• Simultaneous multi-slice scanning. .
• Minimum scan time of 0.3 second. .
• Minimum reconstruction time of 0.5 second. .

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for the Volumax CT scanner, focusing on its intended use, features, predicate devices, and a statement of substantial equivalency. It highlights adherence to safety standards (GMP, IEC 601-1, 21 CFR Subchapter J) but does not detail performance metrics or studies to demonstrate them against specific acceptance criteria.

Therefore, I cannot provide the requested table and study details.

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Whole body Computed Tomography applications and specifically for interventional procedures that are performed on the CT table.

The CT Scope option is an addition to the CT Twin and HeliCAT families of CT . scanners. It comprises of hardware and software for initiation and termination of the scan process and for on-line monitoring of the resulting images in the gantry room, in addition to the Operator Console. Exposure is initiated by one of two pedals near the patient table and terminated by releasing the pedal. Partially reconstructed images are displayed at a rate of 6 images/second with a delay of approximately one second and displayed on a monitor in the scanner room. A handle for holding the needle from outside the direct radiation to reduce the dose received by the doctor during the interventional procedure is also included. The optional LaserGuide may be used for marking the entrance point and angle . of needle insertion externally to the gantry opening for convenience.

The provided text (K974344) describes a 510(k) submission for a “CT Scope option for CT scanners.” This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, much of the requested information regarding specific acceptance criteria demonstration and study details is not available within this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Reason for "Not explicitly stated": The document is a 510(k) summary, which typically focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting de novo clinical trial data with specific performance endpoints and acceptance criteria in the way a PMA (Premarket Approval) might. The "performance" stated here is about fulfilling system specifications and complying with regulations, not clinical accuracy or diagnostic performance.

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

Not applicable/Not provided.
The document does not describe a "test set" in the context of clinical or performance data for an AI/algorithm-based device. The evaluation is focused on engineering verification and validation (that specs are met) and regulatory compliance.

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

Not applicable/Not provided.
No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable/Not provided.
No test set 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/Not provided.
This document describes a CT system option, not an AI or algorithm-based diagnostic tool that would typically undergo an MRMC study.

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

Not applicable/Not provided.
This is not an AI/algorithm-only device. It's an enhancement for existing CT scanners.

7. The type of ground truth used

Not applicable/Not provided.
No "ground truth" in the context of clinical accuracy or diagnostic performance is mentioned. The ground truth for engineering validation would be the functional specifications and regulatory standards.

8. The sample size for the training set

Not applicable/Not provided.
No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable/Not provided.
No training set ground truth establishment is described.

Summary of the K974344 Document's Approach:

The K974344 submission is a 510(k) Premarket Notification for a CT Scope option. Its primary goal is to demonstrate substantial equivalence to predicate devices already on the market (CT-Twin flash, HeliCAT CT scanner, other interventional CT systems).

The evidence provided focuses on:

• Compliance with general controls: GMP practices, International Standards (IEC 601-1), and FDA regulations (21 CFR, Subchapter J performance standards).
• Hazard analysis and control: Identifying potential hazards and demonstrating how they are managed (e.g., software assurance procedures, quality assurance).
• Functional requirements: Stating that the option's specifications and functional requirements were met during internal testing (though no specific test results or data are presented in the summary).

The FDA's response confirms that the device is substantially equivalent for its stated indications for use (whole body CT applications and interventional procedures), meaning it is considered as safe and effective as the predicate devices without requiring a full clinical trial for novel performance claims.

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MAGNETIC RESONANCE IMAGING WHOLE BODY

The modifications include: new imaging sequences: FSAGE, Multishot EPI, Long ETL FSE, SSE, SSV, and diffusion weighted imaging, automated image filtering, MPR, PCA color coded velocity maps, Time Lapse post processing, Real-Time Localizer, double oblique localization, and multiple presaturation.

Here's an analysis of the provided text regarding the Elscint MRI Software Version 3.0, focusing on acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implicitly defined by comparison to the predicate devices. The submission claims the device is "substantially equivalent in safety and effectiveness" and that effectiveness is "improved in non-substantial ways." The actual "study" presented is a direct comparison of technical specifications.

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

• Sample Size for Test Set: Not applicable. The submission does not describe a clinical study with a "test set" of patient data. The effectiveness evaluation is based on a technical parameter comparison to predicate devices, not on a dataset of images or patients.
• Data Provenance: Not applicable. No clinical data is mentioned.

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

• Not applicable. No ground truth for a test set was established. The "truth" is based on the technical specifications of the device and its predicate.

4. Adjudication Method for the Test Set

• Not applicable. There was no test set or expert adjudication process described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The document does not describe human reader performance or the impact of AI assistance. The focus is on the inherent technical capabilities of the MRI system's software version.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not explicitly described as a "standalone study" in the modern sense of AI algorithm evaluation. However, the performance metrics (e.g., minimum TE, TR, FOV) inherently represent the standalone capabilities of the MRI "algorithm" or system software without direct human intervention during the acquisition process. The assessment is purely on the system's technical output.

7. Type of Ground Truth Used

• The "ground truth" for this submission is the technical specifications and performance parameters of the predicate MRI devices. The new software version's performance is compared directly to these established technical benchmarks. There is no biological or clinical ground truth (e.g., pathology, outcomes data) discussed.

8. Sample Size for the Training Set

• Not applicable. This submission describes software updates to an MRI system, not an AI or machine learning model that would require a "training set" of data.

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

• Not applicable, as there is no training set for an AI/ML model.

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The production of a series of images of the heart at different phases of the cardiac cycle.

The modification is a cardiac gating technique referred to as Retrospective Gating. In standard cardiac gating, the acquisition is triggered by the QRS pulse of the ECG. In Retrospective Gating, the scan runs continuously, and the correlation with the QRS cycle is done after the fact. This modification does not involve any changes to the existing hardware of the predicate devices.

The provided 510(k) summary for Elscint's "Retrospective Gating for Elscint MRI Systems" describes a modification to existing MRI systems. However, its focus is on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a detailed study.

Here's an analysis of the submission based on your request, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated. The submission mentions image comparability to existing techniques but does not quantify the sample size (number of patients/scans) used to assess this comparability.
• Data Provenance: Not explicitly stated. Given it's a 510(k) for a device modification, it's likely the "comparable images" refer to internal testing performed by Elscint. It does not specify country of origin or whether it was retrospective or prospective data.

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

• Not applicable / Not explicitly stated. The submission focuses on demonstrating safety and "comparable" image quality to an existing method, implying visual assessment by company engineers/experts. There is no mention of independent experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

• Not applicable / Not explicitly stated. No formal adjudication method is described, as the study design for evaluating "comparability" is not detailed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size

• No. A formal MRMC comparative effectiveness study, as understood in current regulatory submissions for AI/CAD devices, was not performed or described. This submission predates the widespread use of such studies for AI evaluation in medical imaging. The submission simply states images are "comparable" to standard gating.

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

• Yes, implicitly. This is a modification to an MRI system's acquisition technique, not an AI/CAD algorithm that provides diagnoses or measurements. The "performance" being evaluated is the direct output of the modified MRI system (the images themselves). The statement "The Retrospective Gating option produces images that are comparable with those produced using the standard cardiac gating technique" implies a standalone assessment of the image quality produced by the system.

7. The Type of Ground Truth Used

• Implied Expert Observation/Standard of Care: The "ground truth" here is the established quality and diagnostic utility of images produced by the standard cardiac gating technique. The new technique simply needed to demonstrate that its output images were similar in quality and diagnostic information. This would have been assessed by developers and possibly clinical collaborators comparing the two sets of images. It's not "pathology" or "outcomes data" in the typical sense for a diagnostic algorithm, but rather a performative comparison to an existing, validated imaging method.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly stated. This device modification is to an MRI acquisition technique, not an AI / machine learning algorithm that requires a "training set" in the modern sense. The term "training set" is not relevant to this submission.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As this is not an AI/ML device, there is no "training set" or corresponding ground truth establishment process in this context.

Summary of the Study:

The "study" described in the 510(k) summary is a comparative assessment aimed at demonstrating substantial equivalence to predicate devices. It's not a formal, quantitative performance study with specific metrics, statistical power, and independent adjudication typically seen for novel diagnostic devices. Instead, it relies on proving that the new "Retrospective Gating" technique maintains the same safety profile and produces comparable image quality to established cardiac gating methods within Elscint's existing MRI systems (Gyrex 2T Prestige, Gyrex Privilege, Gyrex Prima 1 TG System). The critical assertion is that "the effectiveness of the modified devices is similar to that of the predicate devices." No detailed study protocol, data, or statistical analysis is provided in this summary. It's a high-level claim of equivalence.

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Magnetic Resonance Imaging of small extremity joints.

The modification is the addition of a flexible coil to image the elbow, hand, ankle, foot, and other small extremity joints. The coil is similar in design to the predicate device, a legally marketed Flexible Coil (K944331). The only significant modification is with respect to the frequency for the 2 Tesla model because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems.

Here's an analysis of the provided information, describing the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission for a modification to an existing device, a Flex Coil for MRI systems. As such, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness, rather than meeting specific quantifiable performance metrics for a novel diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Acceptance Criteria

The provided document is a summary of a 510(k) premarket notification. It does not describe a formal scientific "study" in the way one might evaluate a new diagnostic algorithm. Instead, it demonstrates substantial equivalence through a comparison to existing, legally marketed predicate devices and by outlining compliance with relevant safety standards.

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

The document does not explicitly state a "test set sample size" or "data provenance" in terms of patient data. The evaluation appears to be based on:

• Engineering Analysis and Compliance: Demonstrating adherence to IEC safety standards.
• Bench Testing/Performance Evaluation: Stating "acceptable uniformity," "higher SNR," and "better images" compared to the Shoulder Coil. This would imply some form of imaging or phantom tests, but no specifics are given regarding the number of images, phantoms, or human subjects used.
• Comparison to Predicate: The primary "test" is a comparison of the modified device's characteristics against those of the predicate devices.

Given the context of a 510(k) for a coil modification, it's highly likely that this involved a limited number of phantom images and possibly images from volunteer subjects, but no large-scale patient study aiming for statistical significance is described.

• Data Provenance: Not specified, but likely internal testing by Elscint. Retrospective or prospective nature is not indicated for any observed performance.

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

• Not Applicable in the traditional sense. For a device like a new MRI coil, "ground truth" isn't typically established by expert consensus on clinical diagnoses within a test set. Instead, performance metrics like uniformity and SNR are objectively measured. Subjective "better images" assessment might involve internal engineers or physicists, but the number and qualifications are not specified.

4. Adjudication Method for the Test Set

• Not Applicable. As there's no defined "test set" requiring clinical diagnosis or interpretation, no adjudication method would have been used. Performance metrics like SNR and uniformity are objectively measured characteristics of the coil's physical properties.

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

• No. An MRMC study was not done. The effectiveness claims ("higher SNR," "better images") are implicitly based on direct comparison to the predicate shoulder coil, likely through technical specifications or qualitative review, not a formal multi-reader study.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes (Implicitly). The evaluation of the coil's physical performance characteristics (uniformity, SNR) is a standalone assessment of the device hardware. The statement "The Elscint 0.5T and 2T Flex Coils have acceptable uniformity and higher SNR than the Shoulder Coil" indicates a standalone assessment of the coil's imaging capabilities without human interpretation influencing the raw metrics. The claim of "better images" is a subjective standalone assessment.

7. The Type of Ground Truth Used

• For safety: Compliance with international safety standards (IEC-601-1) and material specifications (CPAI-84).
• For effectiveness: Objective physical measurements (e.g., uniformity, SNR, though specific metrics are not provided) and qualitative comparative assessment ("better images") against a predicate device.

8. The Sample Size for the Training Set

• Not Applicable. The device is a hardware component (an MRI coil), not an AI algorithm that requires a "training set" of data.

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

• Not Applicable. As there is no training set, there is no ground truth established for one.

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The intended use and the indications of use of the GLORY mammography system are identical to those of the MAM-CH22S mammography system. Radiography of the breast

The GLORY mammography system describes a modification of the legally marketed MAM-CH22S mammography system (K960381). Compared to the MAM-CH22S mammography system, additional radiation (or mAs) is provided for very thick or dense breasts and higher mA values are provided with the small focal spot for magnification procedures.

Here's an analysis of the provided text regarding the GLORY mammography system, focusing on acceptance criteria and supporting studies:

Based on the provided documents, it's important to note that this is a 510(k) premarket notification for a modification of an already legally marketed device (MAM-CH22S). The submission focuses on demonstrating substantial equivalence rather than presenting an entirely new device with novel performance studies against specific acceptance criteria for a new indication.

Therefore, many of the typical elements of a detailed performance study proving a device meets acceptance criteria (like specific sensitivity/specificity thresholds, MRMC studies, or detailed ground truth establishment for a test set) are not present in these documents. Instead, the focus is on comparing the modified device's technical specifications and safety to the predicate device.

Here's the information extracted from the provided text:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission for a modification, the "acceptance criteria" is primarily demonstrating substantial equivalence in safety and effectiveness to the predicate device (MAM-CH22S). The performance metrics reported are primarily in terms of technical capabilities rather than clinical outcomes.

Study Details

Given the nature of a 510(k) for a modification focused on substantial equivalence, a traditional "study proving the device meets acceptance criteria" in the sense of a large clinical trial with predefined performance metrics is not described here. The "study" is more of an engineering and comparative analysis.

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

   • Not applicable / Not specified. The document does not describe a clinical "test set" of patient data used to evaluate diagnostic performance. The comparison is primarily at a technical specification level.

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

   • Not applicable. No clinical test set with expert-established ground truth is mentioned.

3. Adjudication Method for the Test Set:

   • Not applicable. No clinical test set.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is not mentioned or described.

5. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

   • No. This device is a mammography system (hardware), not an AI algorithm. Standalone algorithm performance is not relevant here.

6. Type of Ground Truth Used:

   • Not applicable. For this type of 510(k), the "ground truth" for demonstrating equivalence largely relies on technical specifications, safety standard compliance, and the established performance of the predicate device.

7. Sample Size for the Training Set:

   • Not applicable. This is a hardware system, not a machine learning model that requires a training set.

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

   • Not applicable. As above, no training set.

Summary of Approach:

The regulatory strategy for the GLORY Mammography System was to demonstrate substantial equivalence to a previously cleared predicate device (MAM-CH22S). The primary evidence for this was:

• Identical Intended Use and Indications: The device performs the same diagnostic function.
• Technical Enhancements: The modifications (additional mAs for dense breasts, higher mA for magnification) were presented as improvements for specific scenarios, not changes that altered the fundamental safety or effectiveness negatively.
• Safety Compliance: Adherence to international safety standards (IEC 601-1) and an analysis of the modifications to ensure no new significant risks.

This type of submission relies on the established safety and effectiveness of the predicate device and the argument that the modifications do not introduce new questions of safety or effectiveness, effectively piggy-backing on the prior clearance. It does not involve de novo clinical studies to establish new performance metrics against specific acceptance thresholds.

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What the user provided is a comprehensive overview of a medical device, which contains the intended use/indications for use. When asked to output the intended use as it appears in this document, the following is provided:

Whole Body Magnet Resonance Imaging

The modification is a new imaging sequence referred to as Echo Planar Imaging (EPI). EPI is an imaging technique which produces multiple gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques.

Here's a breakdown of the acceptance criteria and study information for the Elscint EPI for the Gyrex Prestige and Privilege Systems, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The document refers to "images that are comparable with those produced using other imaging sequences" but does not detail a specific test set. This suggests a more general comparison rather than a formal study with a defined test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed ground truth establishment for a specific test set is not described. The evaluation appears to be a general assessment of image comparability.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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 device is an imaging sequence modification, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an imaging sequence modification, not an algorithm with standalone performance metrics. The effectiveness is assessed by the quality and utility of the generated images.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. The "effectiveness" section states that EPI sequences produce images that are "comparable with those produced using other imaging sequences." This implies a qualitative assessment of image quality and diagnostic information content, likely against established clinical standards or the predicate device's image quality. It's an assessment of image fidelity rather than a ground truth for a diagnostic task.

7. The sample size for the training set: Not applicable. This document describes a modification to an MRI system's imaging sequence, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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Cardiac scoring from whole body computed tomography derived measurements

The Cardiac Scoring option is a software option based on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries.

This document is a 510(k) premarket notification for Elscint Inc.'s "Cardiac Scoring option," a software feature for CT scanners. It focuses on the device's substantial equivalence to a predicate device, rather than providing a detailed study proving its meeting of specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific study designs, and quantitative performance metrics is not present in the provided text.

Based on the provided information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics like sensitivity, specificity, or accuracy. The "Effectiveness" section broadly states:

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

This information is not provided in the document. There is no mention of a test set, patient data, country of origin, or retrospective/prospective nature of any data related to performance evaluation.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided. The document makes no mention of experts or a process for establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Since no test set or ground truth establishment is described, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. The document does not describe any study comparing human readers with and without AI assistance, nor does it mention any effect size.

6. Standalone (Algorithm Only) Performance Study

This information is not provided. The document describes the software's functionality but does not present data from a standalone performance study in terms of quantifiable metrics. The "Effectiveness" section is descriptive rather than quantitative.

7. Type of Ground Truth Used

This information is not provided. As no specific study data is presented, the type of ground truth used is not described.

8. Sample Size for the Training Set

This information is not provided. There is no mention of a training set or its size.

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

This information is not provided. Since no training set is mentioned, the method for establishing its ground truth is also not described.

Summary of what the document does claim regarding "effectiveness":

The core claim for effectiveness is that the "Cardiac Scoring option quantifies calcifications by a weighted number instead of manual calculation of area x density products. As such it is easier to use." The basis for this claim, and the overall "effectiveness" of the device, is its substantial equivalence to predicate devices (specifically, the Histogram and ROI functions of the CT Twin flash, K945512). The document suggests that the device performs a similar function (quantifying high-density structures) but in a more user-friendly way. The effectiveness is therefore asserted through a comparison to a known, legally marketed predicate device rather than through a rigorous, quantitative study with specific acceptance criteria.

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Not Found

The current modification to the Gyrex 2T-Prestige consists of the addition of software to enable the production of 'H spectra are produced using the existing MRI hardware.

The spectroscopy software includes automated shimming, water suppression, transmitter calibration, central frequency calibration, phase correction and display, and higher level spectral processing functions.

This document is a 510(k) summary for a device called "Gyrex 2T Prestige 'H Spectroscopy Option." It's a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in the way you've outlined. This document is a regulatory submission focused on demonstrating substantial equivalence, not on presenting a clinical or performance study with detailed acceptance criteria and results.

Here's why and what information can be extracted:

• Acceptance Criteria/Performance Table: Not applicable because no performance study is described. The document only states "The effectiveness of the system is similar to that of the GE Hydrogen Spectroscopy Option - PROBE (the predicate device)." It doesn't quantify this similarity or list specific performance metrics it had to meet.
• Sample size and data provenance: No performance study is described, so no sample size or data provenance is provided.
• Number of experts and qualifications: No performance study is described that involved experts establishing ground truth.
• Adjudication method: Not applicable as no performance study with ground truth adjudication is described.
• MRMC comparative effectiveness study: Not applicable as no such study is described.
• Standalone performance: Not applicable as no standalone performance study is described. The submission focuses on the addition of software to existing MRI hardware to enable 'H spectroscopy.
• Type of ground truth: Not applicable as no performance study with ground truth is described.
• Sample size for training set: Not applicable as no machine learning model requiring a training set is described. The modification is described as "software to enable the production of 'H spectra."
• Ground truth for training set: Not applicable as there's no training set described.

Summary of available information related to your questions:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Implicitly, the device must perform similarly in effectiveness to the predicate device (GE Hydrogen Spectroscopy Option - PROBE). No specific quantitative criteria are listed.
   • Reported Device Performance: Stated as "The effectiveness of the system is similar to that of the GE Hydrogen Spectroscopy Option - PROBE (the predicate device)." No specific performance metrics or data are provided.

2. Sample size used for the test set and the data provenance: Not provided. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth establishment for a test set is described.

4. Adjudication method for the test set: Not applicable; no test set or adjudication process 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: No MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone performance study, as typically understood for AI algorithms, is described. The modification is software to enable 'H spectroscopy, implying instrumental performance rather than independent algorithmic performance.

7. The type of ground truth used: Not applicable; no ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned in the context of a performance study.

8. The sample size for the training set: Not applicable; no training set for a machine learning model is mentioned.

9. How the ground truth for the training set was established: Not applicable; no training set is mentioned.

Conclusion:

This 510(k) summary focuses on demonstrating that a software addition to an existing MRI system (Gyrex 2T Prestige) to enable 'H spectroscopy is "substantially equivalent" in safety and effectiveness to predicate devices. It achieves this by arguing that:

• Safety aspects (BoodB/dt, acoustic noise, SAR) are unaffected or equivalent to the predicate.
• Software hazards were minimized by design and testing.
• Effectiveness is similar to the GE Hydrogen Spectroscopy Option - PROBE.

It does not provide details of a new performance study with specific acceptance criteria that the new device had to meet and detailed results quantifying its performance against those criteria. The "study" here is the regulatory submission process itself, where the claim of "similarity" is the main argument for effectiveness.

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