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The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.

· NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multi-peak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

· CT System: produces Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications.

· NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping (localization, registration, and fusion).

The Aurora system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.

GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use.

Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system. The CT gantry has been adapted for use with predicate device's NM portion. CT PDU, CT Console Keyboard and CT operator console are the same as in Revolution Ascend Plus.

The provided document does not contain details about specific acceptance criteria, a study proving device performance against those criteria, or the various methodological details requested regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

The document is a 510(k) summary for the Aurora system, indicating that it is a modification of a predicate device (Discovery NM/CT 670) and incorporates components from other cleared devices. The filing emphasizes that, due to the nature of these modifications (primarily replacing a 16-slice CT with a 64-slice CT and other workflow enhancements, while the NM system is largely carried over), clinical testing was deemed unnecessary to demonstrate substantial equivalence.

The document states:

• "Because the changes associated with Aurora do not change the Indications for Use from the predicate and reference devices, and represent equivalent technological characteristics, this type of change supports using scientific, established / standardized, engineering / physics-based performance testing, without inclusion of clinical images for determining substantial equivalence."
• "Given the above information and the type and scope of changes, particularly that the NM imaging component is identical to the predicate, and the CT component is the commercially available Revolution Ascend CT system, clinical images are not included in this submission. Clinical images are not needed to demonstrate substantial equivalence."

Instead of a clinical study, the submission relies on:

• Design control testing per their quality system (21CFR 820 and ISO 13485): including Risk Analysis, Required Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation).
• Conformance to standards: IEC 60601-1 and its applicable Collateral and Particular Standards (IEC 60601-1-2, 60601-1-3, 60601-2-44), as well as performance testing per NEMA NU-1.
• Additional engineering bench testing (non-clinical testing): This was performed to support substantial equivalence, demonstrate performance, and substantiate product claims. Evaluated areas included applicability of cleared lesion detectability and dose/time reduction claims, quantitation accuracy, IQ performance with low dose CT for attenuation correction, and workflow.

Therefore, the requested information cannot be extracted from this document as a clinical validation study demonstrating performance against specific acceptance criteria with human-in-the-loop or standalone performance was not part of the submission for substantial equivalence.

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The GE StarGuide system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging of tumors, planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures. The GE StarGuide system, combining a CZTbased, high energy and spatial resolution, Nuclear Medicine (NM) system and a Computed Tomography (CT) system, is intended to produce:

· NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using tomographic scanning of single or multi-isotopes with either single or multi energy peaks. The tomographic scanning is supported by various acquisition types and by imaging features designed to enhance image quality.

· CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications.

· NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based corrections of SPECT images as well as functional and anatomical mapping imaging (localization, registration and fusion).

The GE StarGuide system includes digital processing of data and images, signal analysis and display equipment, patient and equipment supports, components and accessories. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.

FAME: Functional-Anatomical Mutual Enhancement (FAME) technology is an image processing method intended for Computed Tomography (CT) based corrections of Nuclear Medicine (NM) bone scintigraphy images. FAME adjusts the radioisotope tracer distribution to correlate with the skeletal anatomical structures in the CT image. FAME may be used for patients of all ages.

StarGuide is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available GE Optima CT540 CT system. It is intended for general purpose Nuclear Medicine (NM) imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. The StarGuide system does not introduce any new Intended Use.

Each of StarGuide's twelve CZT detectors can independently rotate about their long axis and "sweep" the field of view (FOV). The detectors can also move rotationally around the gantry and radially in and out, similar to that of the reference device, Spectrum Dynamics' Veriton CT. The detectors on StarGuide's NM system are built up from the identical same CZT modules that are used in the current production version of the predicate device.

StarGuide's table is the same as the one used on the NM/CT 860 reference systems with only slight modifications. StarGuide's "SmartConsole" is the same as that on the NM/CT 850 and NM/CT 860 with modifications made primarily in support of StarGuide image processing. StarGuide's image processing (i.e. reconstruction and post reconstruction processing) uses known algorithms and methods that have been cleared for emission computed tomography (i.e. SPECT, PET). However, StarGuide introduces a new post reconstruction image processing algorithm, FAME, for CT-based correction of NM bone scintigraphy images for better correlation with the skeletal anatomical structures in the CT image.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the StarGuide system, particularly focusing on the FAME technology.

1. Table of Acceptance Criteria and Reported Device Performance (FAME Technology)

The document primarily focuses on the FAME technology as a new image processing algorithm introduced with the StarGuide system. The acceptance criteria for FAME are implicitly tied to its intended purpose as an "image processing method intended for Computed Tomography (CT) based corrections of Nuclear Medicine (NM) bone scintigraphy images. FAME adjusts the radioisotope tracer distribution to correlate with the skeletal anatomical structures in the CT image."

While a formal table of quantitative acceptance criteria for FAME is not explicitly provided with numerical thresholds, the performance is evaluated through a clinical reader study. The key performance indicator reported is that all five experienced Nuclear Medicine (NM) physicians attested that their assessments (using 5-point Likert scales for overall image quality and image resolution) demonstrated acceptable diagnostic results. This qualitative assessment serves as the reported device performance against the implicit acceptance criterion of providing diagnostically acceptable images after FAME processing.

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

• Sample Size for Test Set: 42 SPECT CT exams.
• Data Provenance: The exams were acquired using the StarGuide system at two clinical sites. The text does not explicitly state the country of origin, but it can be inferred that these are clinical settings where SPECT CT exams are routinely performed. The study is prospective in the sense that these specific exams were acquired on the StarGuide system for the purpose of this evaluation.

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

• Number of Experts: Five experienced NM physicians.
• Qualifications of Experts: Described as "experienced NM physicians." No specific years of experience are provided, but the term "experienced" implies sufficient expertise to evaluate diagnostic images.

4. Adjudication Method for the Test Set

The document mentions that the five experienced NM physicians "scored the images using 5 point Likert scales for both overall image quality and image resolution." It does not explicitly detail an adjudication method like 2+1 or 3+1 for discrepancies. Instead, it states that "All of the physicians attested that their assessments demonstrated acceptable diagnostic results," suggesting a consensus on acceptability or individual assessment without requiring a formal adjudication process beyond individual scoring.

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

• The document describes a clinical reader study, which is a type of MRMC study.
• Effect Size of AI vs. Without AI Assistance: The study as described focuses on the diagnostic acceptability of images after FAME processing. It does not provide an effect size comparing human readers with AI assistance versus human readers without AI assistance, or the specific improvement in reader performance. The evaluation is on the acceptability of the FAME-processed images themselves.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The text states, "StarGuide introduces a new post reconstruction image processing algorithm, FAME, for CT-based correction of NM bone scintigraphy images for better correlation with the skeletal anatomical structures in the CT image." The reader study directly evaluates the output of this algorithm as interpreted by human readers. While the algorithm operates "standalone" in its processing, the ultimate performance is assessed through human interpretation, making it difficult to completely separate it. However, the study's focus is on the output of the algorithm and its diagnostic acceptability, which could be considered an evaluation of the algorithm's effect. There isn't a separate, entirely automated, quantitative standalone performance metric reported.

7. Type of Ground Truth Used

The ground truth for the reader study appears to be expert consensus on diagnostic acceptability. The physicians attested to "acceptable diagnostic results" for the images processed with FAME. This is an assessment of image quality and resolution in a diagnostic context, rather than a comparison to pathology or long-term outcomes data.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set used for the FAME algorithm. It mentions that FAME is a "new post reconstruction image processing algorithm," but no details on its development or training data are given in this summary.

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

As no information about a training set is provided, the method for establishing its ground truth is also not mentioned.

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