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The Apollo Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

The Apollo Gamma Camera System offers all the features of the Forte™ Gamma Camera System (K033254) while adding the following new features: Caudal/Cephalic Imaging, a second LEHR collimator with improved sensitivity, new CHR collimator, larger Field of View (FOV) with square cornered detectors,

This document is a 510(k) Summary for the Apollo Gamma Camera System, comparing it to a predicate device, the Forte™ Gamma Camera System. The focus of the submission is on establishing substantial equivalence rather than performing a clinical study with detailed acceptance criteria and performance metrics for a new diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, and performance evaluations cannot be fully extracted as such a study is not part of this 510(k) submission.

Here's a breakdown of why the specific questions cannot be answered based on the provided text, and what can be inferred:

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

• Cannot be provided directly. The document does not specify quantitative acceptance criteria or detailed performance metrics from a formal clinical study. It describes features and improvements over a predicate device.
• Inferred Acceptance Criteria: Substantial equivalence to the predicate device in terms of intended use, indications for use, technological comparison, and overall system performance.
• Reported Device Performance: Instead of specific performance metrics, the document highlights improvements and new features that contribute to better image quality, flexibility, and potentially reduced acquisition time/radiopharmaceutical dosage.

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

• Not applicable / Not provided. This 510(k) summary does not describe a clinical study with a test set of patient data being evaluated for device performance. It focuses on engineering and design comparisons with a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Since there's no clinical study involving interpretation of images by experts to establish ground truth, this information is not present.

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

• Not applicable / Not provided. See explanation for #3.

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 is a gamma camera system, a hardware imaging device, not an AI-powered diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not applicable. This is a hardware system, not a standalone algorithm.

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

• Not applicable / Not provided. As no specific clinical performance study for image interpretation is described, ground truth establishment is not discussed. The "ground truth" for this submission is implicitly the performance and safety established for the predicate device.

8. The sample size for the training set

• Not applicable / Not provided. This document describes a new hardware system (gamma camera) and its features, not a machine learning or AI model that requires a training set.

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

• Not applicable / Not provided. See explanation for #8.

Summary of what the document does provide in relation to "acceptance criteria" and "proof":

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device (Forte™ Gamma Camera System) in intended use, indications for use, technological characteristics, and overall system performance.
• Proof (Argument for Substantial Equivalence):
  • Identical Intended Use and Indications For Use.
  • Technological Comparison: Stating that Apollo and Forte™ are "technologically equivalent" with the same main mechanical and electrical components.
  • New Features: Detailing enhancements in Apollo (e.g., Caudal/Cephalic Imaging, larger FOV, 3/4" detector crystal, ABC with BodyGuard™, 9-axis gantry, DICOM MPPS) that are presented as improvements that maintain or enhance safety and effectiveness, rather than fundamentally altering the device's mechanism or intended use. These improvements aim to "improve image quality," "reduce acquisition time and/or applied radiopharmaceutical dosage."
  • NEMA NU-1 Standard: Mentioning that the 3/4" crystal has higher system sensitivity "per NEMA NU-1, Section 3.8," indicating adherence to recognized performance standards for imaging devices.

In conclusion, this 510(k) summary is a regulatory filing for substantial equivalence based on design and feature comparison, not a clinical trial report with explicit acceptance criteria and corresponding performance data from a patient study.

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JETStream® Workspace is a nuclear medicine image display and processing workstation that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The JETStream® Workspace system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

JETStream® Workspace is a Windows®-based Nuclear Medicine workstation for the Nuclear Medicine market segment. The computer system will consist of a Hewlett Packard XW4300 workstation or HP Compaq nc6230 Notebook or their equivalents. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report generation and contains the utilities necessary to support the workflow and data management between those activities. The system will support connectivity aspects necessary to import and export data as required to accomplish daily work scenarios.

The provided text is a 510(k) summary for the ADAC Laboratories JETStream® Workspace. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, it does not contain a detailed study report with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details about comparative effectiveness studies (MRMC or standalone).

The document primarily focuses on establishing substantial equivalence based on:

• Similar intended use: Processing, analyzing, and displaying nuclear medicine images for diagnosis.
• Technological comparison: Similar display, review, processing applications, data storage, and system utilities to predicate devices.
• System performance: Implied to be similar to predicate devices based on the above, but no specific performance metrics or studies are reported.

Therefore, I cannot populate the requested table or provide detailed answers to most of your questions as the information is not present in the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document asserts "system performance" is similar to predicate devices but provides no specific quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy, processing speed, image quality benchmarks).

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

Not available in the provided text. There is no mention of a specific test set or clinical study data used to demonstrate performance. The submission relies on substantial equivalence to predicate devices.

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

Not applicable/Not available. Since no specific test set or performance study is detailed, there's no mention of experts establishing ground truth for such a study.

4. Adjudication Method for the Test Set

Not applicable/Not available. No adjudication method is described as no test set data is presented.

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

No, it appears no MRMC study was done or reported in this 510(k) summary. The document does not describe any studies involving human readers or comparative effectiveness of AI assistance.

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

No, it appears no standalone performance study was done or reported in this 510(k) summary. The device is described as a workstation with software applications for a nuclear physician to use as a tool, implying human-in-the-loop operation, but no specific standalone algorithm performance is detailed.

7. The Type of Ground Truth Used

Not applicable/Not available. No ground truth type (e.g., pathology, expert consensus, outcomes data) is mentioned because the document does not describe a performance study requiring ground truth.

8. The Sample Size for the Training Set

Not available in the provided text. There is no mention of a training set for any algorithmic development, as the focus is on a workstation for image display and processing, not necessarily an AI diagnostic algorithm.

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

Not applicable/Not available. As there's no mention of a training set, the method for establishing its ground truth is also not mentioned.

In summary, the provided 510(k) documentation focuses on the administrative and regulatory aspects of establishing substantial equivalence to existing devices, rather than presenting a detailed performance study with specific acceptance criteria and results. For a medical device like a workstation for image processing, the "performance" might refer more to its fidelity in displaying images, its processing capabilities (e.g., speed, accuracy of calculations on pixel data), and its adherence to standards, which are not explicitly quantified in this summary.

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AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoQUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

AutoQUANT® Plus (K040326) was composed of the following applications: AutoQUANT® (K040326) [AutoOUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis], Quantitative Blood Pool SPECT (QBS) and optionally QARG (for reporting purposes).

The modified AutoQUANT® Plus is a suite of applications for the processing and review of Cardiac SPECT and PET datasets. AutoQUANT® Plus is composed of the following applications: AutoQUANT® (K040326) [AutoQUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis). AutoQUANT Plus will be marketed as AutoQUANT NM, which combines the following two separate sets of functionality: AutoQUANT - optimized for SPECT studies and OPET - optimized for PET studies. Both sets of functionality offer a comprehensive application suite that includes QGS (Quantitative Gated SPECT) and OPS (Quantitative Perfusion SPECT) applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies. AutoQUANT NM can also be purchases separately as AutoOUANT (for SPECT study data) or QPET (for PET study data). Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA, and Prone-Supine (Prone+) for SPECT studies.

AutoQUANT® is a software application designed to enable an automated, comprehensive review and quantification of Cardiac SPECT data. AutoQUANT® integrates 2 functionalities, Quantitative Perfusion SPECT (OPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis. AutoQUANT® provides a tool to review and quantify all types of Cardiac SPECT data sets (perfusion and/or gated) to determine the location, orientation, and anatomical extent of the left ventricle of the heart, to construct 3D contour maps of the heart, and to calculate the heart volume (for the left ventricular wall), the lung/heart ratio, and transient ischemic dilation (TID). Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects through comprehensive imaging modalities. A new Phase toggle on the OGS page gives access to phase information for gated datasets. Stress-Rest Registration is a direct method for detecting changes between stress and rest images. It is a practical and fully automatic algorithm for quantification of stress-induced changed from paired stress and rest scans and does not use protocol-specific databases. A new technique to create cardiac "motionfrozen" perfusion or viability images, by warping ECG-gated images to the end-diastolic position has been added. Such "motion-frozen" perfusion and viability images have improved resolution and contrast by removing blurring effect caused by cardiac motion. Prone-supine quantification allows quantification of perfusion on prone images as well as combined quantification of prone/supine datasets by applying heuristic rules, which allow automatic elimination of image artifacts based on the relative defect locations on prone and supine images. The new shape index parameter defines 3D left ventricular (LV) geometry derived from LV contours in end systolic and end diastolic phases.

The AutoQUANT application provides Normal Files database for stress, rest, and gender criteria for Dual Isotope and Mibi (Te-Sestamibi): The new version of QPS includes the simplified algorithm for the quantification of myocardial perfusion, using normal limits created from studies of low-likelihood normal patients only. The new algorithm has been validated in a large group of patients demonstrating equivalent diagnostic performance despite the use of simplified normal limits. In addition, to Dual Isotope and Mibi Mibi using the new simplified algorithm, the following additional databases are being provided Vantage MibiMibi, Thallium Stress/Rest, Astonish ½ Time Dual, and Astonish ½ Time Mibi. Optional Normals databases offered are Rubidium for PET, Ammonia for PET. QPS provides the ability for User Generated Normal Files using the simplified method. The new version of QPS also includes a new variable, Total Perfusion Deficit (TPD), which combines defect extent and severity values. For backward compatibility reasons, the old QPS perfusion quantification method, which displays individual defect extent and severity values, can be accessed by checking off PFQ option in the QPS Application Defaults. All the functional QGS values (ejection fraction, LV volumes etc) and contour definitions are the same as before.

Quantitative Blood Pool SPECT (QBS) is an optional application. QBS is an interactive standalone software application for the automatic segmentation and quantification of gated short axis blood pool (red blood cells, RBC) SPECT. The application can be used for automatic generation of left and right ventricular endocardial surfaces and valve planes from three-dimensional (3D) gated short axis blood pool images; automatic calculation of left and right ventricular volumes and ejection fractions; calculation and display of polar maps representing wall motion and parametric values (FFH amplitude and phase); twodimensional (2D) image display using standard American College of Cardiology (ACC) cardiac SPECT conventions; and 3D image display. It also provides the following functionalities: ability to combine isosurfaces extracted from the data with the calculated endocardial surfaces in various ways (endocardial borders displayed as wireframes, shaded surfaces, both, or parametric); ability to man parametric values (First Fourier Harmonic (FFH) amplitude and phase) on the surfaces; ability to display parametric images (FFH amplitude and phase) for gated planar, gated raw projections and gated short axis images; ability to display cine loops of the original images; ability to generate count-based quantitative values using the automatically- and semi automatically-computed surfaces as ROIs and user-selectable thresholds; ability to generate and display phase histograms for FFH phase images and to display the mean and standard deviation of the peaks corresponding to atrial and ventricular voxels. After ventricular segmentation, a phase histogram for each ventricle is also computed and displayed; and ability to display normalized images for all gated images (i.e., images that do not exhibit count drop-off caused by arrhythmia). In addition, QBS supports manual identification of the leftventricular (LV) region, to separate it from the right ventricle (RV) in cases where the automatic algorithm fails or returns unsatisfactory results; ability to generate filling rates from interpolated time-volume curves; and the ability to rotate, zoom, and cine surfaces.

The ability to load and display PET, CT, CTA datasets in AutoQUANT® Plus have been added as an option. Qualitative displays are now provided functional PET data and CT/CTA anatomical datasets. In addition, nuclear image fusion package has been added for both SPECT/CT and PET/CT hybrid applications. A SPECT/CT fusion package including SPECT/CT/CTA Fusion Page, that allows for display of segmented and labeled coronary vessels with perfusion SPECT 3D data. A PET/CT fusion package including PET/CT/CTA Fusion Page, that allows for display of segmented and labeled coronary vessels with PET 3D data. Functionality includes orthogonal planes using alpha blending. roving window and synchronized cursor. It allows users to perform quality control of SPECT/CT/CTA or PET/CT/CTA alignment and has generic multimodality fusion capabilities. This feature provides display of fused images in a visual format. Additionally, included for PET analysis is the Hibernating Myocardium Assessment (mismatch and viability); This module allows quantitative assessment of "hibernating myocardium" by quantification of changes between PET perfusion and viability images in hypo-perfused area. Scar and Mismatch parameters are reported as a percentage of the Left Ventricle and are displayed in polar coordinates or a 3D surface display.

The provided text is a 510(k) Summary for the AutoQUANT® Plus device. It describes the device's functionality and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (AutoQUANT® Plus, K040326), rather than presenting performance metrics against specific acceptance thresholds.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) that the device must achieve.
• No Performance Study Results: While it mentions that "The new algorithm has been validated in a large group of patients demonstrating equivalent diagnostic performance," it does not provide any quantitative results, sample sizes for such a validation, details of ground truth establishment, or expert qualifications. It only states an equivalence, not a direct measurement against a predefined acceptance criterion.
• Focus on Substantial Equivalence: The primary purpose of a 510(k) summary is to establish that a new device is as safe and effective as a legally marketed predicate device, not to present a detailed performance study against acceptance criteria.

To answer your request, a different type of document, such as a detailed design validation report or a clinical study report, would be necessary.

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Precedence is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The x-ray computed tomography subsystems may consist of a whole body multi-slice CT or cardiovascular CT. The cardiovascular subsystem provides coronary imaging that is intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at difference angles and planes. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.

The Precedence CV Configuration CT subsystem is only for the imaging of the cardiovascular system.

The Precedence SPECT/CT Imaging System is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT sequentially (dual-modality studies) wherein the SPECT and CT studies may be automatically coregistered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuclides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses.

Precedence is constructed from two existing systems, the Skylight SPECT Imaging System and the Brilliance CT with subsystem options of 6, 16, or 64 slice or the CVCT configuration. The Precedence has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Precedence SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance.

Precedence is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The clinical protocols and procedures are that are available on the modified Precedence Imaging System are the same as those on the Predicate Devices Precedence SPECT/CT (cleared as Griffin) (K041218), Predicate Philips Plus CT Scanner (K033326), and the Brilliance CT, Private Practice CV configuration CT Scanner (K042293). The intended use of the CV configuration CT Scanner is limited to the heart, cardiovascular, and peripheral vascular systems. Acquired SPECT and CT images on the Precedence may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image. The Precedence CV Configuration CT subsystem is not indicated for imaging structures that are defined as non-cardiac and non-vascular (including soft tissue and bone).

The provided text describes the "Precedence SPECT/CT Imaging System" and its substantial equivalence to predicate devices, rather than a study with detailed acceptance criteria and reported device performance against those criteria in the way typically seen for novel AI/ML devices.

However, based on the information provided, I can infer the "acceptance criteria" relate to regulatory compliance and general system performance, and the "study" is more of a validation of substantial equivalence to a predicate device.

Here's an attempt to structure the information as requested, drawing inferences where specific details are not explicitly stated:

Acceptance Criteria and Device Performance for Precedence SPECT/CT Imaging System

The "acceptance criteria" for the Precedence SPECT/CT Imaging System are primarily based on demonstrating substantial equivalence to predicate devices and adherence to established radiation and electrical safety standards. The "study" mentioned is a system performance test focused on these regulatory and safety compliance aspects.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of a clinical test set. The validation is based on engineering and performance standards compliance, and substantial equivalence to predicate devices. There is no mention of a patient or image test set for evaluating diagnostic performance.
• Data Provenance: Not applicable. The validation is regulatory and technical, not clinical trial-based.

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

• Number of Experts: Not applicable. Ground truth, in the sense of expert-reviewed images for diagnostic accuracy, was not established for this submission. The "ground truth" here is compliance with established engineering and safety standards and the performance of predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there was no test set requiring ground truth establishment through expert adjudication processes.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical specifications and regulatory compliance, not human reader performance with or without AI assistance. The device combines modalities; it does not explicitly state an AI component that assists human readers in a way that would warrant such a study.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone (algorithm only without human-in-the-loop performance) study was not done. The "Precedence SPECT/CT Imaging System" is a combined hardware system, not a standalone algorithm. Its performance is measured through adherence to standards like NEMA NU-1 and a demonstration that the combined system functions as intended without degrading the performance of its constituent parts.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this regulatory submission is adherence to established engineering standards (NEMA NU-1, IEC 60601-1 series), radiation safety regulations (21 CFR 1020.30 & 1020.33), and the demonstrated performance of its predicate devices. There is no mention of clinical ground truth like pathology, expert consensus on patient outcomes, or diagnostic accuracy against a gold standard.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The Precedence SPECT/CT Imaging System is described as a hybrid system constructed from existing and cleared SPECT and CT systems. It does not appear to involve a de novo AI/ML component requiring a "training set" in the conventional sense. The "training" for the system refers to its design and calibration based on established physics and engineering principles, not machine learning.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for an AI/ML algorithm. The "ground truth" for the system's development would stem from the design specifications and performance characteristics of the underlying SPECT and CT technologies, which are assumed to be well-established and validated independently.

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AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide enhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, providing enhanced reconstruction algorithms that include resolution recovery, scatter correction, noise compensation, and attenuation correction via application of a transmission dataset.

AutoSPECT is a software application that produces images, which depict the threedimensional distribution of radiopharmaceutical tracers in a patient via automatic or manual processing. One or more cardiac SPECT, gated SPECT, or MCD cardiac data sets may be processed automatically using AutoSPECT. Additionally, one or more non-cardiac SPECT, gated SPECT, or MCD data sets may be processed manually. AutoSPECT contains basic data-processing algorithms that have been cleared previously; in addition to enhanced data reconstruction algorithms that include scatter correction, resolution recovery, map-based attenuation correction, and OSEM (Astonish SPECT) reconstruction.

The AutoSPECT software option may be used on images from a gamma camera system that are DICOM 3.0 compatible. The following data sets may be used:

• Cardiac, brain, or other (bone, liver, etc.) SPECT datascts .
• . Gated SPECT datasets
• . Vantage SPECT datasets
• SPECT-CT datasets .
• Total Body SPECT datasets
• MCD and MCD-AC datasets .

AutoSPECT provides the user three options for automatically processing cardiac datasets: AutoAll, Auto Recon, and Auto Reorient. Each option is described in greater detail in the software description section.

AutoSPECT also allows the user to process non-cardiac SPECT and MCD datasets. In this case, the operator manually positions the reconstruction limit lines to reconstruct transverse data sets. If necessary, the data set can be reoriented manually by positioning the azimuth, elevation, and twist lines to the desired locations.

In addition, the capability of processing groups of SPECT data sets in a batch mode fashion is provided. Once the operator has selected the datasets and determined the processing method, AutoSPECT processes the first dataset, followed by all remaining datasets without further interaction from the user.

AutoSPECT application runs on Microsoft Windows XP Professional environment. The minimum hardware requirements is listed:

• . Intel x86/Pentium class processor > 1 GHz ;
• Graphics capability must meet or exceed 1280x1024 pixels with 32 bit pixel . depth;
• . 30 Gb of disk space (minimum);
• . 512 Mb of DRAM (minimum);
• . 10/100 BaseTX Ethernet interface;
• . Port capable of supporting a dongle;
• . CD drive- capable of reading and writing:
• 56Kbps modem (minimum) .

This document is a 510(k) summary for the AutoSPECT® device, a software application for processing gamma camera emission images. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with specific quantitative metrics or a study demonstrating the device meets those criteria. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, rather than establishing new performance criteria through a specific study with defined acceptance thresholds.

The "performance" described is largely qualitative, focusing on enhanced reconstruction algorithms.

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

The document does not specify a test set size nor the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing. The submission is a comparison to a predicate device and description of new features, not a report on a clinical performance study with a test set.

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

Not applicable. The document does not describe a study involving a test set with expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The document does not describe a study involving a test set with an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No, an MRMC comparative effectiveness study is not mentioned or described in this document. The submission focuses on device features and comparison to a predicate, not human reader performance with or without the AI.

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

No, a standalone algorithm performance study is not mentioned or described. The document describes a software application that processes images for human interpretation, not a fully automated diagnostic system.

7. The Type of Ground Truth Used:

Not applicable. The document does not describe a study involving any form of ground truth for performance evaluation.

8. The Sample Size for the Training Set:

Not applicable. The document does not provide details of a training set as it describes a software application and its features, not a machine learning model developed with a training dataset.

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

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

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Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.

Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes.

The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care.

Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

Pinnacle3 Radiation Therapy Planning System version 7.2 (hereafter Pinnacle' RTP) provides radiation therapy planning for the treatment of benign or malignant diseases. When using Pinnacle3 RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can approvide plans for various radiation therapy modalities including External Beam Treatment, Stereotactic Radiosurgery, and Brachytherapy.

Pinnacle3 RTP is a software package that runs on a Sun UNIX (or UNIX compliant) computer and consists of a core software module (Pinnacle') and optional software features. These optional software features, commonly referred to as "plug-ins", are typically distributed separate from the core software product (separate CD-ROM). The device has network capability to other Pinnacle RTP workstations and to both input and output devices via local area network (LAN) or wide area network (WAN).

Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOMmage atta interface. A qualified medical professional uses the Pinnacles RTP for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan. The viowing and analyzing are examples of tasks that may be performed by clinicians when using the Pinnacle' RTP system:

• Evaluate the treatment plan based on radiation-sensitive structures and the tumor. ◆
• Combine both geometric and dosimetric planning on the same platform, including CT . simulation data and plans. The CT simulation parts of the system are called AcQSim² and Simulation.
• Configure beam variables such as energy, geometry, and beam modifiers such as blocks, . wedges, multi-leaf collimators, bolus and compensators.
• Visualize the beam on a display, initiate the dose computation, and set the weight of each . beam.
• Obtain dose measurements from any Points of Interest (POI). .
• Perform photon and electron physics modeling, dose algorithm and machine ● commissioning. This functionality is supported by the Physics Utility Module.
• Evaluate images away from the workstation via a laptop or physician group workstation. . The feature that provides remote review is referred to as P3MD.
• Create data for use in conjunction with treatment QA systems. .
• Configure, backup, archive, restore, and scripting. .
• Evaluate Digitally Reconstructed Radiographs (DRRs) on Pinnacle RTP or remote system . using DICOM Secondary Capture (SC) Export.

Once complete, Pinnacle3 RTP has the ability to transfer the finished plan to other devices used in Onec comprete, I minute - Record and Verify, Linear Accelerator (Linac) Workstations and/or 310 Party QA systems.

The following Pinnacle³ RTP features are also available to assist the clinician with the radiation therapy planning process. These features are distributed on standalone CD-ROM media, and installed onto the Pinnacle' RTP workstation. Corresponding instructions for use such as User Guides or Release Notes are also provided to the clinician for each optional feature.

P3IMRT (Intensity Modulated Radiation Therapy):
P INKT (Incentines both forward and inverse planning functionality. The system determines a plan that satisfies the user's treatment goals through an optimization process. The user's treatment goals are specified as objectives and constraints based on dose distribution characteristics.

Syntegra (also referred to as AutoFusion):
Syntegra (utomates multi-modality image registration and fusion by overlaying images from CT, MR, PET, PET-CT and SPECT devices using a DICOM-compliant interface. This feature provides clinicians with the ability to relate, interpret and contour an image's anatomic and functional information.

In addition to the above, the following software options are available to facilitate image and/or data import and export between radiation therapy devices such as the imaging camera, Pinnacle' RTP, and Record & Verify system. DICOM is the acronym for Digital Imaging and Communications in Medicine and is an internationally recognized standard for transferring biomedical information such as images and data between devices or over a network.

DICOM RT:
DICOM RT software is used to support both Structure Set and Radiation Therapy Plan import and export functions. Structure Sets describe regions and points of interest to other systems. Plan information includes beam geometry and delivery information.

DICOM Image:
DICOM Image software is used to support image import and export to and from the Pinnacle RTP workstation according to the NEMA DICOM standard, version 3.0. This functionality allows diagnostic imaging devices supporting the DICOM 3.0 standard to interface with the Pinnacle system.

Mitsubishi DME:
A proprietary interface has been created within the Pinnacles Treatment Planning System to support plan export to Mitsubishi Record and Verify systems. This interface is called the "Mitsubishi DME" system. This is implemented as a simple file based interface according to a format specified by Mitsubishi.

P3 MD:
P3MD allows for treatment plan review and minor alternations by a physician from a PC-based workstation that is connected to the same network as the primary Pinnacle Treatment Planning workstation.

The provided text is a 510(k) Pre-market Notification for the Pinnacle3 Radiation Therapy Planning System version 7.2. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.

Key takeaway regarding "acceptance criteria" and "study proving acceptance criteria":

510(k) notifications, especially for software modifications to existing devices like this one, do not typically present formal "acceptance criteria" and "studies proving acceptance criteria" in the same way one would find for a novel device or a clinical trial. Instead, they focus on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of why and what information is available from the document:

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

• Not Applicable in a traditional sense for this document. The concept of "acceptance criteria" for this submission would be demonstrating that the new features (DMLC support, physics tool improvements) function as intended and do not raise new safety or effectiveness concerns compared to the predicate device.
• The document explicitly states: "Verification and Validation test plans were completed in compliance with ADAC Laboratories procedures and will be utilized to demonstrate that the Pinnacle Radiation Therapy Planning System version 7.2 has met its specifications, demonstrates substantially equivalent performance to the predicate device and is safe and effective for its intended use."
• The specific "reported device performance" against quantifiable "acceptance criteria" for the new features (e.g., DMLC accuracy within X%, physics model improvement by Y%) is NOT detailed in this summary. Such details would be part of the internal ADAC Laboratories verification and validation documentation, which is reviewed by the FDA but not typically fully included in the public 510(k) summary.

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

• Not specified in the publicly available summary. The summary refers to "Verification and Validation test plans" but does not detail the specifics of test sets, sample sizes, or data provenance.
• Given this is a software update and not a new diagnostic tool interacting directly with patient data, a "test set" in the sense of clinical images might not be the primary focus of the V&V. It would likely involve testing the software's computational accuracy and functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not specified. The document mentions the involvement of "qualified medical personnel" for using the system and evaluating plans, but does not detail their role in establishing ground truth for testing the device itself.
• For radiation therapy planning systems, "ground truth" often relates to known physics principles, phantom measurements, or comparisons to established planning systems for dose calculations.

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

• Not specified. This is typically relevant for studies involving human interpretation or subjective assessments, which are not directly described for this software update.

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, an MRMC comparative effectiveness study was explicitly NOT required. The document states: "Summary of Clinical Tests: Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness."
• This also means there is no reported effect size for human readers improving with AI, as the device is not presented as an "AI assistance" tool in this context, but rather an updated radiation therapy planning system.

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

• The "Verification and Validation test plans" would have involved standalone testing of the algorithms (e.g., dose calculation, DMLC path generation) to ensure they meet specifications. However, the details of these standalone tests are not provided in the summary. The device's function is inherently "algorithm only" in terms of its core computations, with human oversight for plan approval.

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

• Not explicitly stated in the summary. For a radiation therapy planning system, ground truth for dose calculation and DMLC functionality would likely involve:
  • Physics models: Comparison of calculated dose distributions to established physics models and phantom measurements.
  • Reference data: Comparison of DMLC movements to designed or theoretical paths.
  • Simulations against known parameters.
• It would not typically involve expert consensus on image interpretation, pathology, or patient outcomes data for device validation in a 510(k) for a dose planning system update.

8. The sample size for the training set:

• Not applicable. This device is a radiation therapy planning system, not a machine learning model that requires a "training set." It is based on deterministic physics algorithms and software logic.

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

• Not applicable, as there is no training set for this type of device.

In summary of the provided text:

The document is a 510(k) submission focused on demonstrating substantial equivalence of an updated radiation therapy planning system (Pinnacle3 version 7.2) to a previously cleared version (K032724). The primary changes are support for dynamic multileaf collimator (DMLC) treatment planning and improvements to the physics tool.

The "study that proves the device meets the acceptance criteria" is broadly referred to as:

"Verification and Validation test plans were completed in compliance with ADAC Laboratories procedures and will be utilized to demonstrate that the Pinnacle Radiation Therapy Planning System version 7.2 has met its specifications, demonstrates substantially equivalent performance to the predicate device and is safe and effective for its intended use."

However, the detailed methodology, specific acceptance criteria, test set sizes, ground truth establishment, or clinical study outcomes are not contained within this public 510(k) summary. These details would be part of the complete 510(k) submission reviewed by the FDA, but are not disseminated in the public summary. The FDA determined that clinical testing was "not required" for this particular device update.

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Griffin is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Griffin may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Griffin may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Griffin Imaging System should only be used by trained healthcare professionals.

The Griffin SPECT/CT Imaging System (Griffin) is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT scquentially (dual-modality studies) wherein the SPECT and CT studies may be automatically co-registered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuctides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses. Griffin is constructed from two existing systems, the Skylight Imaging System (K031705) and the Brilliance CT (K012009). The Griffin has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Griffin SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance. Griffin is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The same clinical protocols and procedures are available on the Griffin Imaging System as in the predicate SPECT or CT systems. Acquired SPECT and CT images on the Griffin may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image.

The provided document is a 510(k) Premarket Notification for the Griffin SPECT/CT Imaging System. It describes the device, its intended use, and comparison to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.

The document states that the system performance was tested in accordance with the NEMA-NU-1 standard and compliance with radiation safety standards (21 CFR 1020.30 and 21 CFR 1020.33). However, it does not provide the specific acceptance criteria derived from these standards or the quantitative results of these tests. Instead, it concludes that the device is "substantially equivalent" to predicate devices based on intended use, technological comparison, and system performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the detailed information about sample sizes, experts, ground truth, or MRMC studies, as this information is not present in the provided text.

Based on the information available, here's what can be extracted regarding System Performance and Compliance:

System Performance and Compliance (as described in the document)

The document states compliance with general safety and performance standards, rather than presenting a performance study with specific acceptance criteria as you've requested.

Regarding the other requested information, the document does NOT provide the following:

1. Sample sizes used for the test set and the data provenance: No information on test sets, patient data, or data provenance is provided.
2. Number of experts used to establish the ground truth for the test set and qualifications: No information on expert review for ground truth is available.
3. Adjudication method for the test set: Not applicable as no specific test set or adjudication process is described.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The document focuses on substantial equivalence to predicate devices, not improvement over human readers with AI assistance.
5. Standalone (algorithm only without human-in-the-loop performance) study: This device is an imaging system, not an AI algorithm. Its performance is inherent in its hardware and software for image acquisition and display, not a standalone AI algorithm.
6. Type of ground truth used: Not applicable as no specific performance study with a defined ground truth is described.
7. Sample size for the training set: Not applicable, as this is a hardware imaging system, not a machine learning algorithm requiring a training set in the typical sense.
8. How the ground truth for the training set was established: Not applicable for the same reason as above.

Conclusion:

The K041218 submission for the Griffin SPECT/CT Imaging System demonstrates substantial equivalence primarily by comparing its intended use, technology, and compliance with general performance and safety standards to predicate devices (Skylight Imaging System and MX8000 IDT CT System). It does not present a detailed study with quantitative acceptance criteria and results as typically found for novel diagnostic algorithms or AI-driven devices.

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Syntegra™ is a software application for multi-modality image registration and diagnostic fusion. Images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined functional and anatomical data providing different angular perspectives for interpretation by trained professionals

Syntegra™ is a software application for multi-modality image registration and diagnostic fusion. This application exists within the predicate device, Gemini 16 (K032036). The Gemini 16 is an imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). This PET/CT device includes the processing station and applications contained within, such as image fusion. Syntegra™ may be offered as a standalone software application that has the capability to be utilized on any PC image processing workstations meeting the minimum hardware requirements to support the application.

Registration is the process of aligning two or more images from the same patient so that physical positions within each image are coincident. The images may be from the same imaging modality or different imaging modalities.

Fusion display is the visual combination of two image data sets that allows the data sets to be displayed simultaneously in a blended mode in the same screen window. The level of be arejected by user adjustable opacity values assigned to each data set. A common application of fusion display is the combination of physiological data from SPECT images and anatomical information from CT images.

Images are registered and displayed in a fused format to provide combined functional and anatomical data. The images are presented using various three-dimensional rendering techniques such as multi-planar reformatting, surface rendering with cut-planes, and maximum intensity projections.

Syntegra also offers Region of Interest tools. These are tools, which allow a user to draw two-dimensional contours around areas of interest on the transaxial image planes. The contours may then be exported to Radiation Therapy Planning systems, which use the two dimensional contours to generate three-dimensional volumes, which may be used in therapy planning.

The application operates on WindowXP/Intel Pentium computer systems with the following minimum requirements:

• Graphics Card: 24/32 bit color, support for 1400x1162 screen resolution .
• RAM: 1 GB .
• Processor: Pentium IV and above .
• Clock Speed: 1GHz clock speed .

The provided text describes a 510(k) summary for the Syntegra™ device, which is a software application for multi-modality image registration and diagnostic fusion. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for testing or training sets.

The document focuses on:

• The device's intended use and description.
• Comparison to a predicate device (Philips Medical Systems Gemini 16, K032036).
• A declaration of substantial equivalence to the predicate device.
• The FDA's letter of clearance.

Therefore, I cannot provide the requested information from the given text. The text explicitly states "Syntegra is substantially equivalent to the image fusion software application from the following predicate device, Gemini (K032036), based on similar intended use and technological comparison." This suggests that the substantial equivalence argument was made based on technological comparison to an existing device rather than a new performance study against specific acceptance criteria.

To answer your request, I would need a different document that details the performance study conducted for Syntegra™, including the acceptance criteria and study results.

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AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoOUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

AutoQUANT® Plus is a suite of applications for the processing and review of Cardiac SPECT and blood pool SPECT datasets. AutoOUANT® Plus is composed of the following applications: AutoQUANT® (K980715) [AutoQUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis], Quantitative Blood Pool SPECT (QBS) (K022428), and optionally QARG (for reporting purposes). Previously, the marketing clearance for QBS (K022428) was scparate and is now being combined with the AutoOUANT Plus 510(k) being submitted.

AutoQUANT® is a software application designed to enable an automated, comprehensive review and quantification of Cardiac SPECT data. AutoQUANT® integrates 2 functionalities, Quantitative Perfusion SPECT (OPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis. AutoQUANT® provides a tool to review and quantify all types of Cardiac SPECT data sets (perfusion and/or gated) to determine the location, orientation, and anatomical extent of the left ventricle of the heart, to construct 3D contour maps of the heart, and to calculate the heart volume (for the left ventricular wall), the lung/heart ratio, and transient ischemic dilation (TID). Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects through comprehensive imaging modalities.

Also included in AutoQUANT Plus is Quantitative Blood Pool SPECT (QBS). OBS is an interactive standalone software application for the automatic segmentation and quantification of gated short axis blood pool (red blood cells, RBC) SPECT. The application can be used for automatic generation of left and right ventricular endocardial surfaces and valve planes from three-dimensional (3D) gated short axis blood pool images; automatic calculation of left and right ventricular volumes and ejection fractions; calculation and display of polar maps representing wall motion and parametric values (FFH amplitude and phase); two-dimensional (2D) image display using standard American College of Cardiology (ACC) cardiac SPECT conventions; and 3D image display. It also provides the following functionalities: ability to combine isosurfaces extracted from the data with the calculated endocardial surfaces in various ways (endocardial borders displayed as wireframes, shaded surfaces, both, or parametric); ability to map parametric values (First Fourier Harmonic (FFH) amplitude and phase) on the surfaces; ability to display parametric images (FFH amplitude and phase) for gated planar, gated raw projections and gated short axis images; ability to display cine loops of the original images; ability to generate count-based quantitative values using the automatically- and semi automatically-computed surfaces as ROIs and user-selectable thresholds; ability to generate and display phase histograms for FFH phase images and to display the mean and standard deviation of the peaks corresponding to atrial and ventricular voxels. After ventricular segmentation, a phase histogram for each ventricle is also computed and displayed; and ability to display normalized images for all gated images (i.e., images that do not exhibit count drop-off caused by arrhythmia). In addition, QBS supports manual identification of the left-ventricular (LV) region, to separate it from the right ventricle (RV) in cases where the automatic algorithm fails or returns unsatisfactory results; ability to generate filling rates from interpolated time-volume curves; and the ability to rotate, zoom, and cine surfaces.

In addition, an automatic report generation (ARG) feature has been added to AutoQUANT® Plus. This option in AutoOUANT produces consistent PDF (or text) reports based on a series of form elements within AutoQUANT . The tool consists of an additional window within AutoQUANT and does not alter any quantitative values. This is designed to reduce transcription errors and automate workflow. A separate QARG application allows searching and management of the ARG database, which requires all data to be manually entered. There are no algorithmic functions within the ARG/QARG feature.

The provided text is a 510(k) summary for the AutoQUANT® Plus device. It describes the device's intended use, its components, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, details of a study proving those criteria were met, or most of the other requested information related to detailed performance studies.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

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

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

This information is not available in the provided 510(k) summary. Acceptance criteria and specific performance metrics are typically detailed in a separate performance study report, which is not part of this summary document. The 510(k) summary focuses on "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria.

Regarding the study that proves the device meets the acceptance criteria:

The provided document describes the device and its intended use but does not include details of a study designed to prove the device meets specific acceptance criteria. Instead, it relies on a "Technological Comparison" to predicate devices to establish "substantial equivalence."

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

• Sample size for the test set: Not mentioned.
• Data provenance: Not mentioned. The document primarily discusses the software applications and their functionalities, not specific datasets used for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Number of experts: Not mentioned.
• Qualifications of experts: Not mentioned.

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

• Adjudication method: Not mentioned.

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: Not mentioned. The document does not describe any studies involving human readers or their improvement with AI assistance.

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

• The document implies standalone functionality for the segmentation and quantification aspects (e.g., "automatic segmentation and quantification," "automatic generation of left and right ventricular endocardial surfaces"). However, it does not explicitly provide performance metrics from a standalone study. The intended use states "results provided should be reviewed by qualified healthcare professionals," suggesting a human-in-the-loop context for clinical decision-making.

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

• Type of ground truth: Not mentioned.

8. The sample size for the training set:

• Sample size for the training set: Not mentioned.

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

• How ground truth was established: Not mentioned.

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