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The ImagenSPECT™ 3.0 system is a software application that provides a processing environment for the analysis and display of cardiac SPECT and planar images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT 3.0 is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. This software can also be used for processing display and quantitation of multigated acquisition blood pool scans (MUGA) specifically the left ventricular ejection fraction (LVEF). ImagenSPECT™ 3.0 can also be used for quantitation of planar and SPECT, early and late 99mTc pyrophosphate images.

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECTT™ 3.0 is used to quantitate the uptake of 99™Tc pyrophosphate in early and late planar and SPECT studies. The ImagenSPECTTM 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (K152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

Here's a breakdown of the acceptance criteria and the study details for ImagenSPECT™ 3.0, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes comparative studies against predicate devices and statistical measures of agreement and difference. I will present the reported performance and infer the implicit acceptance criteria based on these comparisons.

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

The document does not specify the exact sample size for the test set for each study. It indicates that the studies involved:

• "patient data" for 99mTc pyrophosphate and MUGA LVEF comparisons.
• "patient studies" for the one-quarter time myocardial perfusion SPECT evaluation.
• "phantom studies" for the one-quarter time myocardial perfusion SPECT signal-to-noise ratio.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the comparison to the Siemens e.soft system, it's likely the data was collected in a clinical setting in a country where such systems are used, but specific details are absent. The nature of the studies (comparison to existing methods) suggests they could be retrospective analyses of existing patient data, but this is not confirmed.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Instead, the ground truth appears to be established by the measurements obtained from the predicate Siemens e.soft system or conventional OSEM reconstructions, which are presumably considered the clinical standard.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The comparisons are statistical correlations and t-tests against established methods, not against expert consensus that would typically require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies described focus on the algorithm's performance in comparison to predicate systems, not on how human readers' performance improves with or without AI assistance.

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

Yes, the studies described are primarily standalone (algorithm only) performance evaluations. ImagenSPECT™ 3.0's calculations and reconstructions (e.g., heart contralateral ratios, LVEF, one-quarter time SPECT) are directly compared against the results from predicate systems (Siemens e.soft, conventional OSEM). There is no mention of human-in-the-loop performance evaluation in these specific studies.

7. The Type of Ground Truth Used

The ground truth used in these studies appears to be based on:

• Measurements from legally marketed predicate devices: Siemens e.soft system for 99mTc pyrophosphate heart contralateral ratios and MUGA derived LVEF.
• Conventional reconstruction methods: Full-time unfiltered reconstructed perfusion images and conventional ordered subsets expectation maximization (OSEM) reconstructions for one-quarter time myocardial perfusion SPECT.

This can be broadly categorized as "predicate device/method comparison" rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not specify the sample size for any training set. It focuses solely on the verification and validation studies (test sets) comparing ImagenSPECT™ 3.0 against predicate devices/methods.

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

Since no information is provided about a training set or its sample size, there is no information on how ground truth for a training set was established.

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The ImagenUniversaJTM system is a software. application that allows the user to visualize raw PET and/or PET/CT data, to correct for transmission and emission, and to correct PET 3D data for photon scatter and prompt gamma photons. The resulting corrected tomograms can be exported to cardiac interpretive software for interpretation. The use of this system is limited to qualified, licensed healthcare providers (radiologists or nuclear med icine physicians) trained in the use of nuclear medicine imaging devices.

ImagenUniversal™ is a Windows application which allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise. The system processes perfusion and gated PET reconstructed emission and transmission data to create corrected 3D tomographic data. The user can select correction parameters, filter settings, range of reconstruction, and registration setting. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The provided text describes the ImagenUniversal™ system, a software application designed to correct myocardial perfusion PET images. While the document is a 510(k) summary, it does not contain the detailed study information or acceptance criteria typically found in a clinical study report.

The document states:

• "Testing and comparison of technological characteristics and intended uses found that all components of the ImagenUniversal™ system are equivalent to the predicates." This implies that the device was evaluated against existing, legally marketed predicate devices (Siemens Biograph 64 and 40 (K060631), Siemens Biograph mCT (K151486), and ImagenPRO (K050366)) to demonstrate substantial equivalence, a common pathway for 510(k) clearances. However, the specifics of this "testing and comparison" are not provided.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not explicitly present in the provided text.

Based on the information available, a summary can be constructed, but with significant gaps.

Summary of Acceptance Criteria and Study Information (Based on Provided Text)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide detailed performance metrics for the ImagenUniversal™ system. The primary claim is substantial equivalence to predicate devices.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text mentions the system processes "raw PET and/or PET/CT data," implying clinical data, but no further details are given.

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

• Number of Experts: Not specified.
• Qualifications: Not specified. The device's intended users are "qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices." It is plausible that such experts would be involved in any evaluation, but this is not stated.

4. Adjudication Method for the Test Set:

• Not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• Not explicitly stated. The submission focuses on substantial equivalence to predicates, not a comparative effectiveness study demonstrating performance improvement with or without AI assistance. The device is described as a software application for correction, not necessarily an AI-assisted diagnostic tool in the sense of directly interpreting images.

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

• Not explicitly stated in terms of a formal standalone performance study. The device's function is to "correct" raw data into tomograms that "can be exported to cardiac interpretive software for interpretation." This implies an upstream processing role rather than a direct interpretive role, so a standalone diagnostic performance evaluation in the traditional sense might not be directly applicable or detailed here. However, the "testing and comparison of technological characteristics" would inherently involve evaluating the algorithm's performance in generating corrected images.

7. The Type of Ground Truth Used:

• Not specified. Given the nature of the device (correcting for transmission/emission misregistration, scatter, prompt gamma), ground truth would likely relate to the accuracy of these corrections compared to an ideal or gold standard measure, or the resultant image quality and diagnostic utility as assessed by experts. However, these specifics are not provided.

8. The Sample Size for the Training Set:

• Not specified. The document does not mention a training set, which may or may not be relevant depending on the specific algorithms employed for corrections (e.g., if machine learning models are used).

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

• Not applicable / Not specified. As no training set is mentioned, the method for establishing its ground truth is also not provided.

In conclusion, the provided FDA 510(k) summary focuses on establishing substantial equivalence to predicate devices based on "testing and comparison of technological characteristics and intended uses." It does not provide the detailed study design, acceptance criteria, sample sizes, or ground truth methodologies that would typically be found in a comprehensive clinical study report to explicitly "prove" device performance against specific, quantifiable acceptance criteria.

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The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.

ImagenSPECTTM is a Windows application which allows physicians and healthcare professionals to inspect. reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter setting, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The ImagenSPECT™ system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation.

I am sorry, but the provided text does not contain the detailed study information required to answer your request. The document is a 510(k) premarket notification acceptance letter and a 510(k) summary for the ImagenSPECT™ device.

While it mentions that "Testing and comparison of technological characteristics and intended uses found that all components of the ImagenSPECT™ system are equivalent to the predicates," and that "half-count density (full-time scan, half dose/ half-time, full dose), reconstructed with ImagenSPECT using resolution recovery, iterative reconstruction was equivalent to the predicate with the same claim," it does not provide the specific details of the study, acceptance criteria, reported performance values, sample sizes, ground truth establishment, or expert qualifications that you asked for.

Therefore, I cannot compile the table or provide the requested information based on the given input.

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The Imagen3D™ system is software application that works in conjunction with ImagenPRO® to correct for photon scatter and prompt gamma contamination present in PET 3D data. The resulting 3D datasets can be reconstructed using ImagenPRO® to produce PET and/or PET/CT reconstructed tomograms.

Imagen3D™ is a Windows application that works in conjunction with ImagenPRO® as an additional processing step for data acquired in 3D (septa retracted mode). Because of the increase count rate of PET scanners in 3D mode, a lower dosage of the radiopharmaceutical is recommended to avoid dead time issues with the scanners. The resulting 3D sinograms can then be processed in ImagenPRO® to produce 3D tomograms. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The Imagen3D™ system is designed to take Fourier rebinned sinogram data from commercially available dedicated PET and PET/CT systems acquired in 3D (septa retracted) and scatter correct the data for export into ImagenPRO® for tomographic processing.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Imagen3D™ device:

Based on the provided text, the Imagen3D™ application functions as a pre-processing step for PET 3D data, specifically to correct for photon scatter and prompt gamma contamination before reconstruction by ImagenPRO®. The FDA clearance is based on a determination of substantial equivalence to predicate devices, rather than a clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested elements regarding acceptance criteria, performance metrics, and detailed study methodologies (like sample sizes, expert qualifications, adjudication, effects of AI on human readers, and detailed ground truth establishment methods for large datasets) are not present in this 510(k) summary. This type of summary typically focuses on demonstrating equivalence to legally marketed devices based on similar technological characteristics and intended use.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the provided document. The 510(k) summary does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy, or quantitative image quality metrics) that the device had to meet. Instead, the basis for clearance is "substantially equivalent" to predicate devices.

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

Not explicitly stated for a formal test set with performance metrics. The summary mentions "testing and comparison of technological characteristics" but does not detail the nature or sample size of this testing, nor the provenance of any data used beyond the implicit use of "Fourier rebinned sinogram data from commercially available dedicated PET and PET/CT systems." It doesn't specify if this testing involved a distinct "test set" in the sense of a clinical validation study.

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

Not applicable. Since specific performance metrics based on a defined "test set" and ground truth are not detailed in this 510(k) summary, information about experts for ground truth establishment is not provided.

4. Adjudication Method for the Test Set

Not applicable. As above, a formal adjudication method for a test set is not described.

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

No. The summary does not mention an MRMC study or any assessment of how human readers improve with or without AI assistance. The device is a pre-processing software, not directly an AI interpretive assistant for readers.

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

Yes (implicitly, for its intended technical function). The Imagen3D™ is described as a "software application" that "works in conjunction with ImagenPRO® to correct for photon scatter and prompt gamma contamination." Its performance, therefore, is its ability to execute this correction. The statement "Testing and comparison of technological characteristics and intended uses found that all components of the Imagen3D™ system are equivalent to the predicates" implies a standalone assessment of its functional capability as a scatter correction algorithm, even if not quantified with clinical performance metrics in this summary.

7. The Type of Ground Truth Used

Implicitly, the expected output of successful scatter correction. Given the device's function to "correct for photon scatter," the "ground truth" for its operation would be what an ideal, scatter-corrected PET 3D dataset should look like or how it should behave. This is typically established through physics models, phantom studies, or comparisons to established scatter correction methods on relevant data, rather than clinical outcomes or pathology for diagnostic performance. The summary doesn't explicitly state the methodology for establishing this ground truth (e.g., physical phantoms, simulated data, or comparison to established algorithms).

8. The Sample Size for the Training Set

Not applicable / Not provided. The summary does not describe any machine learning or AI models that would require a distinct "training set." The Imagen3D™ appears to be a rule-based or algorithmic scatter correction software rather than a learned model.

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

Not applicable / Not provided. Since there's no mention of a training set, the establishment of ground truth for such a set is not detailed.

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The ImagenMD™ with ImagenQ™ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.

ImagenMD™ with ImagenQ™ is a Windows software application which allows physicians and healthcare professionals to inspect, quantitatively and automatically perform calculations on myocardial perfusion PET images. The user can perform quality assessments, automatically and manually select myocardial boundaries and alignment, and visualize the results of quantitative perfusion calculations. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

This submission, K080770, describes the ImagenMD™ with ImagenQ™ system, a Windows software application designed to inspect, quantitatively and automatically perform calculations on myocardial perfusion PET images. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, the provided text does not contain information regarding
acceptance criteria, a specific study proving the device meets said criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or details on how ground truth was established for training.

The submission primarily states that the device is "equivalent to the predicates" based on "testing and comparison of technological characteristics and intended uses." This implies that the device's functionality and output are comparable to existing, legally marketed devices, rather than establishing numerical performance metrics against pre-defined acceptance criteria.

Based on the provided text, the following information can be extracted/deduced:

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

   • Not provided. The submission asserts substantial equivalence to predicate devices without detailing specific performance metrics or acceptance criteria.

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

   • Not provided. The submission does not describe a clinical performance study with a defined 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 test set or ground truth establishment process is described in the provided document.

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

   • Not applicable. No test set or 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 provided. No MRMC study is mentioned.

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

   • Not provided. The device is described as assisting qualified healthcare providers, implying it's not a standalone diagnostic tool, and no standalone performance study is detailed.

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

   • Not provided. No information on ground truth is available.

8. The sample size for the training set:

   • Not provided. No information on a training set is available.

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

   • Not provided. No information on a training set or its ground truth establishment is available.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence by comparing technical characteristics and intended uses to existing predicate devices, rather than presenting a detailed performance study with quantifiable acceptance criteria.

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The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.

ImagenPRO™ is a software application installed on desktop computers which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angles. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The provided text does not contain any information about acceptance criteria, device performance metrics, or any study design details.

The document is a 510(k) summary for the ImagenPRO™ system, which is a software application for viewing, reconstructing, and reorienting myocardial perfusion PET images. The focus of the provided text is on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

The key points from the provided text are:

• Device Description: ImagenPRO™ is a software application for inspecting, reconstructing, and reorienting myocardial perfusion PET images.
• Indications for Use: To visualize raw PET/CT data, reconstruct myocardial perfusion PET/CT images, and reorient PET/CT reconstructed tomograms.
• Predicate Devices: Siemens/CTI Accel (K002584) and GE Discovery LS (K023988).
• Substantial Equivalence: The document states that "Testing and comparison of technological characteristics and intended uses found that all resting and companison of won™ system are equivalent to the predicates." This is the primary "proof" presented, but it's a comparison of characteristics and intended uses, not a performance study against specific acceptance criteria.
• FDA Clearance: The letter confirms the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided text.

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The ImagenMD™ system is a software and computer system that allows the user to view myocardial perfusion SPEC or PET images from a remote location. The system allows the user to view quantify and process perfusion and gated SPECT images.

ImagenMD™ is a software application installed on laptop computers which allows physicians and healthcare professionals to view myocardial perfusion SPECT or PET images from their office, hospital or home. The system processes perfusion and gated SPECT performing quantitative data analysis. The user can select raw, short axis, transmission slice and gated short axis studies for the purpose of examining those images for abnormalities and artifacts. The system contains optional databases which quantify the extent and severity of myocardial defects. Also included is an application for the display and analysis of gated short axis blood pool SPECT datasets. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The provided document does not contain information regarding a specific study with acceptance criteria and reported device performance. It is a 510(k) summary for the ImagenMD™ system, which primarily focuses on establishing substantial equivalence to predicate devices rather than presenting detailed clinical trial results or performance metrics against defined acceptance criteria.

The document describes the device, its indications for use, and compares its technical characteristics to predicate devices (AutoQUANT, SeeMor, QBS). It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
6. Standalone (algorithm only) performance study details.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission for premarket notification (510(k)), which typically demonstrates equivalence to existing legally marketed devices rather than providing the detailed clinical study data often found in PMA submissions or peer-reviewed publications.

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