(62 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Meet specification requirements | "The performance tests indicate that the D-SPECT® Processing and Reviewing Workstation meets the specification requirements." |
| Implicit: As safe and effective as predicates | "Bench testing demonstrated that the D-SPECT® Processing and Reviewing Workstation is as safe and effective as the cleared predicate devices." |
| Compliance with relevant standards | Confirmed compliance with ISO 62304, ISO 14971, ISO 15223-1, IEC 60601-1-4, IEEE Std 3333.2.1-2015, DICOM PS 3.1-3.18. |
| No new safety/effectiveness concerns | "Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or identify any new risks." |
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.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.