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The Hitachi Oasis MRI with Spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.

This package is indicated for use as follows:

Anatomical Region: Head, whole body Nuclei Excited: "H

MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.

The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".

The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Hitachi Oasis MRI with Spectroscopy:

Device: Oasis MRI with Spectroscopy

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not specify a separate test set, its sample size, or the provenance of any data used for a performance study. The submission relies on substantial equivalence to a predicate device.

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

This information is not provided as the submission relies on substantial equivalence and does not detail a separate performance study with a test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the submission relies on substantial equivalence and does not detail a separate performance study with a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The basis for approval is substantial equivalence to a predicate device, not a head-to-head comparison demonstrating improved human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of the algorithm without human-in-the-loop performance was not performed or reported in this submission. The document describes the system as a diagnostic device where the spectral data is "interpreted by a trained medical practitioner."

7. Type of Ground Truth Used

The concept of a "ground truth" for a performance study is not directly applicable or mentioned in this submission, as the basis for approval is substantial equivalence to a predicate device rather than a de novo clinical performance study against a defined ground truth. The device's utility is described as providing information useful in diagnosis when interpreted by a medical practitioner.

8. Sample Size for the Training Set

This information is not provided. The submission does not describe the development or training of new algorithms for which a training set would be required. It focuses on the capabilities of the spectroscopy package using existing MR hardware and software.

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

This information is not provided, as a training set and its ground truth establishment are not discussed in the context of this substantial equivalence submission.

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The Hitachi Echelon MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.

This package is indicated for use as follows:

Anatomical Region: Head, whole body 1H Nuclei Excited:

MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.

The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".

The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.

The provided 510(k) summary (K071506) for the Hitachi Echelon MR Spectroscopy Package does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The submission focuses on establishing substantial equivalence to a predicate device (Picker MR Spectroscopy Package K991568) based on intended use and similar technology, rather than presenting a performance study with defined acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

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PROstate Spectroscopy and imaging Exam (PROSE) is an image guided, clinical imaging and spectroscopy package which acquires high resolution anatomical images and volume localized, water/lipid suppressed hydrogen spectra and/or multi-voxel spectroscopic images of the prostate gland using an endo-rectal coil with phased-array coils. PROSE option can be used in conjunction with a Magnetic Resonance Scanner to permit non-invasive acquisition of high resolution images and spectral information about relative concentrations of metabolites of prostate gland that can be interpreted by a trained physician, and yield information that may assist in diagnosis of prostate diseases.

PROSE is a version of the PRESS (Point RESolved Spectroscopy), "double" spin echo pulse sequence that uses a 90° and two slice selective refocusing RF pulses to generate a spin echo from a localized volume. PROSE utilizes the standard Graphic Prescription tools and one or more sets of localizer images to determine the size and location of the spectroscopic volume.

The provided document is a 510(k) summary for the PROstate Spectroscopy and imaging Exam (PROSE) software option. It primarily focuses on demonstrating substantial equivalence to a predicate device and safety, rather than providing detailed performance acceptance criteria and a study proving those criteria.

Therefore, many of the requested sections about specific performance metrics and study details cannot be fully answered from the given text.

Here's a breakdown of what can be extracted and what cannot:

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

Explanation: The document states that "Evaluation testing was done to verify the performance of the option in the clinical environment," but it does not specify what performance metrics were evaluated or what the acceptance criteria for those metrics were. It does not provide any numerical results to report against acceptance criteria.

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

• Sample size for the test set: Not specified.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified. The document mentions "interpreted by a trained physician," but this is for clinical use, not for establishing ground truth in a study.

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

• Adjudication method: Not specified.

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

• MRMC study done: Not mentioned.
• Effect size of human reader improvement: Not applicable, as no such study is reported.

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

• Standalone performance study done: Not mentioned. The device is described as "clinical imaging and spectroscopy package... can be interpreted by a trained physician," implying human involvement.

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

• Type of ground truth: Not specified.

8. The sample size for the training set

• Training set sample size: Not specified. The document does not describe a machine learning model that would typically have a separate training set. It describes a software option for an MR scanner.

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

• How ground truth for training set was established: Not applicable, as no training set is described.

Summary of available information:

The document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems PROBE software option, K930265) and ensuring safety.

• Key points mentioned:
  • PROSE is a software option for GE Magnetic Resonance Scanners.
  • It's an image-guided, clinical imaging and spectroscopy package for the prostate gland.
  • It acquires high-resolution anatomical images, volume-localized, water/lipid suppressed hydrogen spectra, and/or multi-voxel spectroscopic images.
  • It uses an endo-rectal coil with phased-array coils.
  • The information can be interpreted by a trained physician to assist in diagnosing prostate diseases.
  • It was evaluated for safety according to IEC 601-2-33.
  • Evaluation testing was done to verify performance in the clinical environment, but no specific performance data or acceptance criteria are provided.
  • The manufacturer concludes it "does not result in any new potential hazards."

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The Picker MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.

This package is indicated for use as follows:
Anatomical region: Head, whole body
Nuclei Excited: 1H

Picker's MR Spectroscopy Package described in this submission is a proton ('H) spectroscopy software option. The package includes both capabilities for single voxel proton (SVP) spectroscopy and chemical shift imaging (CSI). These techniques provide a non-invasive method for analyzing metabolite concentrations in the brain and throughout the body. The MR Spectroscopy Package does not include any additional risks to the patient other than those for standard MR imaging.

The provided document is a 510(k) premarket notification for the Picker MR Spectroscopy Package. It asserts substantial equivalence to predicate devices rather than proving specific acceptance criteria through a dedicated study with quantitative performance metrics. Therefore, many of the requested sections (e.g., sample sizes, ground truth establishment, MRMC studies) are not applicable as they would be for an AI/ML-based device seeking de novo authorization or a device with new performance claims.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of quantitative performance thresholds for a novel device. Instead, it demonstrates substantial equivalence to legally marketed predicate devices by comparing various technological characteristics and intended uses. The "performance" reported is essentially the device's feature set and capabilities, shown to be similar to the predicates.

Note on Acceptance Criteria: In this context, "acceptance criteria" is interpreted as demonstrating that the device's technical specifications and intended use are sufficiently similar to (or improved upon, while maintaining safety and effectiveness) those of already legally marketed predicate devices. The FDA's issuance of the 510(k) clearance acts as the "proof" that these criteria for substantial equivalence have been met.

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

Not applicable. This is a 510(k) submission asserting substantial equivalence based on a comparison of device specifications and intended use, not a clinical trial with a test set of patient data to measure performance against a quantitative endpoint.

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

Not applicable. No test set requiring expert-established ground truth was part of this 510(k) submission.

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

Not applicable. No test set requiring adjudication was part of this 510(k) 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. The device described is an MR Spectroscopy Package, a hardware/software option for an MRI system that provides spectral data, not an AI-assisted diagnostic tool designed to directly improve human reader performance in interpreting images.

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

Not applicable. This device is a diagnostic tool that provides data for interpretation by a trained medical practitioner ("human-in-the-loop"), as stated in its intended use. It is not a standalone algorithm providing diagnoses without human involvement.

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

Not applicable. As this is a substantial equivalence claim for a diagnostic tool's specifications, there was no ground truth validation required for clinical performance in the manner an AI/ML algorithm would need.

8. The sample size for the training set

Not applicable. This device does not appear to involve machine learning models that would require a "training set" in the conventional sense. The submission focuses on the technical characteristics and intended use of the spectroscopy package.

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

Not applicable. No training set was used.

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SAGE 7 is a package of software tools for MR spectroscopic data processing and display. SAGE 7 is indicated for use for a wide variety of MR spectroscopic data management tasks, including file handling, display, processing/modeling, analysis, storage and hard copy output. The resultant spectroscopic presentations, when interpreted by a trained physician, can provide physiological / chemical information that can be useful in determining a diagnosis.

The GE SAGE 7 Spectroscopy Analysis Software is designed to operate on GE Signa Horizon Systems and GE Advantage Windows workstations. It provides a toolkit of software applications to handle a wide variety of tasks associated with spectroscopy data management. The SAGE (Spectroscopy Analysis GE) package provides the capability for the trained clinical spectroscopist to reconstruct, analyze, and display spectra and spectroscopic images to provide information to support a diagnosis. SAGE 7 provides a tool for the spectroscopist to process raw spectroscopy data into spectra or spectroscopic images, view them, and optionally perform numerical analyses to obtain spectroscopic parameters (ex. peak positions, widths, heights, areas, etc.).

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond a general equivalence claim. The document is a 510(k) summary for a software enhancement (SAGE 7 Spectroscopy Analysis option) and primarily focuses on demonstrating substantial equivalence to a predicate device (SA/GE Analysis option).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the SAGE 7 Spectroscopy Analysis option was evaluated against the International medical equipment safety standard IEC 601-2-33 ("Particular requirements for the safety of magnetic resonance equipment for medical diagnosis"). It concludes that the device is "comparable to the SA/GE Spectroscopy option."

However, no specific performance metrics (e.g., accuracy, sensitivity, specificity, processing speed, output consistency) or acceptance criteria (e.g., "must achieve X% accuracy," "processing time must be less than Y seconds") are mentioned or reported for either the SAGE 7 or the predicate device in this document. The "performance" is implicitly tied to safety and substantial equivalence to an already marketed device.

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

The document does not specify a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective clinical data). The evaluation appears to be based on a comparison of features and capabilities rather than a performance study on a specific dataset.

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

The document does not mention any experts being used to establish ground truth for a test set.

4. Adjudication Method:

Given that no test set or ground truth establishment is described, there is no mention of an adjudication method.

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

The document does not mention an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The focus is on the software tool itself, not its impact on human interpretation.

6. Standalone Performance Study:

A standalone performance study (algorithm only) as typically understood (e.g., reporting metrics like accuracy, sensitivity, specificity on a dataset) is not described. The "Summary of Studies" section refers to evaluation against a safety standard and comparison to a predicate device, not a performance study using a defined algorithm output and ground truth. The device is described as "a toolkit of software applications," and its output (spectroscopic presentations) is intended to be "interpreted by a trained physician."

7. Type of Ground Truth Used:

Since no specific performance study is detailed, no specific ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for evaluation.

8. Sample Size for the Training Set:

The document does not mention a training set size. The device is described as "software tools" and "spectroscopy analysis option," implying it's an analytical tool rather than a machine learning model that typically undergoes a training phase with a specific dataset.

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

As no training set is mentioned, there is no information on how ground truth for a training set was established.

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Siemens developed the Clinical Phosphorus Spectroscopy Option for the Magnetom Vision system to allow the non-invasive in vivo analysis of energy metabolites in muscle, liver and heart tissue. The package allows observation of phosphocreatine (PCr), inorganic phosphate (Pi), Adenosine triphosphate (ATP), phosphomonoester (PME), phosphodiester (PDE) levels. Information provided by phosphorus spectroscopy data allows evaluation of the energetic state of examined tissues and intracellular pH, measured from the chemical shift of Pi.

The new Clinical Phosphorus Spectroscopy Option for the MAGNETOM VISION consists of hardware/software extensions, a new rf surface coil, and a new quality assurance phantom.

I am sorry, but your request could not be fulfilled. The document does not contain the necessary information to answer your questions because it is a very old 510(k) summary (from 1996) and describes a "Clinical Phosphorus Spectroscopy Option" for an MRI system, not an AI/ML device. Therefore, a study that proves the device meets the acceptance criteria is not included in the provided text. Additionally, the information requested in your prompt (such as "sample size", "ground truth", "reader study", etc.) is typically associated with the evaluation of AI/ML-driven devices and is not applicable to the traditional medical device described in this document.

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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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