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The D-SPECT® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data.

The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics' D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation.

The system is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras. The system can run on a dedicated workstation or as part of Spectrum Dynamics' D-SPECT® Cardiac Scanner System. The NM data can be coupled with registered and/or fused X-Ray CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas of mIBG I-123 (AdreView tm Iobenguane I-123 Injection) or similar agents within the heart.

D-SPECT® Processing and Reviewing Workstation is intended for acceptance, transfer, display, storage, and processing of images for detection of radioisotope tracer uptakes in the patient's body. The device using various processing modes supported by the various clinical applications and various features designed to enhance image quality. The emission computerized tomography data can be coupled with registered and/or fused CT/MR scans and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. Visualization tools include segmentation, color coding, and polar maps. Analysis tools include Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) measurements, Multi Gated Acquisition (MUGA) and Heart-to-Mediastinum activity ratio (H/M). It also includes reporting tools for formatting findings and user selected areas of interest. It is capable of processing and displaying the acquired information in traditional formats, as well as in three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.

D-SPECT® Processing and Reviewing Workstation is based on Windows operating system. Due to special customer requirements and the clinical focus the D-SPECT® Processing and Reviewing Workstation can be configured in the same way as the predicate device with different combinations of Windows OS based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.

D-SPECT® Processing and Reviewing Workstation is a processing workstation primarily intended for, but not limited to cardiac applications. The workstation can be a part of the FDA cleared D-SPECT® Cardiac Scanner System (K110507) or integrated to a separate standalone post processing station. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas within the heart of mIBG I-123 (AdreView™ Iobenguane I-123 Injection) or similar agents.

The D-SPECT® Processing and Reviewing Workstation, a nuclear medicine workstation, underwent testing to demonstrate its safety and effectiveness.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document states that "The performance tests indicate that the D-SPECT® Processing and Reviewing Workstation meets the specification requirements." However, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and reported device performance metrics are not explicitly listed in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant standards.

Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions that a "overall performance study using a simulated phantom and a dataset of subjects" was performed.

• Test Set Sample Size: The exact number of subjects in the "dataset of subjects" is not specified.
• Data Provenance: The country of origin for the data is not specified. The document indicates the study was performed in accordance with FDA guidance for Computer-Assisted Detection Devices. It is a pre-clinical study utilizing both a simulated phantom and a dataset of subjects. It appears to be retrospective as data collection usually precedes such studies for regulatory submission.

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

This information is not provided in the document. The document mentions "automated review and quantification," but does not detail how ground truth for the subject dataset was established or if it involved expert interpretation or consensus.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth on the test set is not specified in the provided text.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not explicitly mentioned or described. The study described ("overall performance study") focuses on the device's standalone performance validating its safety and effectiveness against specifications. The document also states that the device is intended for "automated review and quantification."

6. If a Standalone Study Was Done

Yes, a standalone study was done. The document states: "To demonstrate and validate the safety, effectiveness and clinical use of the modified D-SPECT® Processing and Reviewing Workstation using SUMO application, Spectrum Dynamics performed a number of validation and verification tests including overall performance study using a simulated phantom and a dataset of subjects..." This describes a study evaluating the performance of the algorithm/workstation itself.

7. The Type of Ground Truth Used

The type of ground truth used for the subject dataset is not explicitly stated. It would typically involve clinical diagnosis, often based on expert interpretation of imaging, pathology, or other clinical outcomes, but this is not detailed in the provided text. The mention of "simulated phantom" suggests a known, controlled ground truth for that part of the study.

8. The Sample Size for the Training Set

The sample size for any training set is not specified. The document describes performance tests and validation, but does not detail the development or training of any machine learning components (if present and if requiring a training set), beyond stating "automated review and quantification."

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

The method for establishing ground truth for any potential training set is not specified, as the document does not elaborate on the development or training process for the automated review and quantification tools.

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D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.

Spectrum Dynamics' D-Spect™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist and to the syringe containing the radiopharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed detector head. The special scanning geometry and detector technology, enable shorter scan times. In the modified D-Spect™ device, a Processing Station was added. The Processing Station, which is part of the display equipment, contains a software application with the Cedars Sinai Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) software that enables a review and quantification of cardiac SPECT data.

This 510(k) summary describes a modification to an existing SPECT device, the D-Spect™ Cardiac Scanner System, with the primary change being the addition of a Processing Station that incorporates Cedars-Sinai Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) software. The submission focuses on demonstrating the substantial equivalence of the modified device to the predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "gold standard Cedars-Sinai test cases" for computer platform testing but does not quantify the number of cases or patients.
• Data Provenance: The "gold standard Cedars-Sinai test cases" suggest that the data was generated at Cedars-Sinai Medical Center. The text does not specify if the data was retrospective or prospective.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The term "gold standard Cedars-Sinai test cases" implies a pre-established, authoritative reference, but the method for their creation or any subsequent adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The clinical validation was for the QGS and QPS programs themselves, conducted by Cedars-Sinai Medical Center, rather than a comparison of human reader performance with and without AI assistance. The QPS and QGS software modules are considered quantitative analysis tools within the SPECT system, not explicitly "AI assistance" in the context of improving human reader interpretation in a comparative study.

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

• Standalone Performance: Yes, the performance testing described for the QGS and QPS programs ("Functionality tests" and "Computer platform testing... using gold standard Cedars-Sinai test cases") can be considered a standalone assessment of the algorithms' ability to process and quantify SPECT data according to their specifications. These tests focus on the software's output based on input data, without explicit human intervention in the interpretation loop during these specific validation steps.

7. The Type of Ground Truth Used

• Ground Truth Type: "Gold standard Cedars-Sinai test cases" were used. While the specific nature of this "gold standard" isn't detailed, in the context of QPS and QGS (quantitative perfusion and gated SPECT), the ground truth would likely be established from well-characterized clinical datasets with confirmed diagnoses or outcomes, possibly correlated with other imaging modalities or invasive procedures to determine actual perfusion defects or cardiac function. It implies a high level of confidence in the accuracy of these reference cases.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document focuses on the validation of existing software (QPS and QGS), which implies these programs were already trained prior to their integration into the D-Spect system. The FDA submission is about the device's substantial equivalence and the functionality of the integrated software, not the development or training of the QPS/QGS algorithms themselves.

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

• Training Set Ground Truth Establishment: Not explicitly stated. As mentioned above, the focus is on the validation of pre-existing QPS/QGS software. The methodology for establishing ground truth during the original development and training of these Cedars-Sinai algorithms is not part of this 510(k) submission.

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D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.

Spectrum Dynamics' D-Spect™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist and to the syringe containing the radio-pharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed detector head. The special scanning geometry and detector technology, enable shorter scan times.

The provided document is a 510(k) summary for the D-SPECT System, an emission computed tomography system for cardiac applications. However, it does not contain specific acceptance criteria or an explicit study report detailing the device's performance against such criteria for the purpose of demonstrating substantial equivalence beyond general safety and performance standards.

The document primarily focuses on establishing substantial equivalence to predicate devices (Virgo and Cardiarc) based on similar intended use and technological characteristics, and by demonstrating compliance with recognized general performance and safety standards.

Therefore, the following information cannot be fully provided based on the given text:

1. A table of acceptance criteria and the reported device performance: No specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular clinical task) are mentioned, nor are quantitative performance metrics reported against such criteria. The document states that performance tests demonstrate the device can be safely and effectively used, but not how it quantitatively meets specific performance benchmarks.

2. Sample size used for the test set and the data provenance: Only "Sample images from three clinical cases" are mentioned as clinical performance data. This is an extremely small sample and likely not a formal test set for statistical evaluation. Data provenance (country of origin, retrospective/prospective) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method for the test set: 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: An MRMC comparative effectiveness study was not done. The device is a standalone imaging system, not an AI-assisted interpretation tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the D-SPECT system as producing images through computer reconstruction of data, and these images are then presumably interpreted by human readers. The clinical performance data presented (Sample images from three clinical cases) suggests a qualitative assessment rather than a quantitative standalone performance evaluation with metrics like sensitivity/specificity against a ground truth. The focus is on the device's ability to "produce cross-sectional images" and "detect the location and distribution of gamma ray radionuclides."

7. The type of ground truth used: Not explicitly stated for the "three clinical cases." Given the nature of a SPECT device, ground truth for myocardial perfusion imaging would typically involve a combination of patient symptoms, additional diagnostic tests (e.g., angiography, stress echocardiography), and clinical follow-up. However, this is not detailed in the document.

8. The sample size for the training set: Not mentioned. The document does not describe the use of machine learning that would typically involve a training set. The device is described as operating on "the same basic principle and the same basic technology as other SPECT devices."

9. How the ground truth for the training set was established: Not mentioned, as no training set for a machine learning algorithm is described.

Summary of what can be extracted from the document:

• Device Name: D-Spect™ Cardiac Scanner System
• Intended Use/Indication for Use: "An emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. Primarily intended for cardiac applications. Supports radionuclides within the energy range of 40 -170 keV."
• Study Design (Clinical Data): "Sample images from three clinical cases using the D-SPECT device." This is an observational presentation, not a formal clinical study with performance metrics.
• Non-Clinical Test Data: The device underwent "extensive safety testing, performance testing, and validation" including:
  • EMC and Safety testing (IEC/EN-60601-1 and IEC/EN 60601-1-2)
  • Testing according to relevant sections of NEMA NU 1 standard (Performance Measurements of Scintillation Cameras)
  • Software validation testing.
• Conclusion from Tests: "The performance tests demonstrate that D-SPECT device may be safely and effectively used myocardial perfusion imaging. The software validation and performance validation tests for scintillation cameras (NEMA NU 1), as well as the clinical images provided, demonstrate that the D-SPECT device meets its design and performance specifications and is substantially equivalent to the predicate devices."

In essence, the 510(k) summary provided here relies on compliance with established safety and performance standards (like NEMA NU 1 for scintillation cameras) and qualitative clinical image review, rather than a detailed clinical study with quantitative acceptance criteria for diagnostic performance.

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