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The D-SPECT® Cardiac Scanner is an emission computed tomography system intended for detection of radioisotope tracer uptake in the patient's body and produce cross-sectional images through computer reconstruction of the data. The system uses 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 and Dynamic) and tomographic mode (Static, Multi-gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control, and low count rate (low dose) acquisition without loss of image quality.

The D-SPECT® Cardiac Scanner may consist and display equipment contain data and image processing software to produce images in a variety of trans-axial and reformatted planes. To perform analysis and uptake quantitation and to apply the appropriate filters. The system utilizes combined images for attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion).

The D-SPECT® Cardiac Scanner is intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac or individual organs diseases. The system output can be used for planning, guiding, and monitoring therapy.

Spectrum Dynamics D-SPECT® Cardiac Scanner System is a single photon emission computing tomography system intended for detection of radioisotope tracer uptake in the body and produce cross-sectional images through computer reconstruction of the data.

The device uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. System's scanning modes include planar mode (Static, Multi-Gated and Dynamic) and tomographic mode (Static, Multi-Gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control. The device may proceed a low count rate (low dose) acquisition without loss of image quality. The device may utilize variate modalities to create attenuation corrected images along with functional and anatomical mapping imaging (localization, registration and fusion).

The device is a high performance and compact Single Photon Emission Computed Tomography system intended for imaging of the breast and additional small organs in order to aid in the evaluation of lesions.

The system detectors support radionuclides within the energy range of 40 -170 Kev.

D-SPECT® Cardiac Scanner System comprising detector head, gantry, patient supports, uninterruptible power supply (UPS), image display and processing equipment, gating and real-time body movement control tools, interconnecting cables and related appurtenances.

The device is available in two models, D-SPECT with nine detectors configuration and the D-SPECT L with six detectors configuration.

D-SPECT® Cardiac Scanner System consist integrated signal analysis and display equipment or may use an FDA cleared D-SPECT® Processing and Reviewing Workstation (K160120) for image processing.

The provided text describes the D-SPECT® Cardiac Scanner System, an emission computed tomography system. However, the document does not contain explicit acceptance criteria and a detailed study report proving the device meets those criteria with specific performance metrics.

The text mentions "All testing results are met the predetermined acceptance values" but does not elaborate on what these values are or the specific results. It also states "The device efficacy and safety as well as the performance specifications remain the same," referring to a previous 510(k) cleared device (K110507). Without the original K110507 submission or a more detailed current submission, specific acceptance criteria and performance data are unavailable in this document.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the text provided:

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

This information is not explicitly stated in the provided document. The document mentions: "All testing results are met the predetermined acceptance values." and "The device efficacy and safety as well as the performance specifications remain the same." This implies that the device's performance matches or exceeds the criteria established for the predicate device (K110507) and potentially international standards, but the specific metrics are not provided.

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

This information is not available in the provided text. The document refers to "performance validation testing" but does not specify details about patient data, sample sizes, or provenance.

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):

This information is not available in the provided text. The document mentions the device is intended for use by "appropriately trained healthcare professionals," but it doesn't describe any studies involving experts establishing ground truth.

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

This information is not available in the provided text.

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:

This information is not available in the provided text. The device described is a SPECT imaging system, not an AI-assisted diagnostic tool, so an MRMC study comparing AI assistance would not be directly relevant to its fundamental performance.

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

This device is an imaging system, not an algorithm in the typical sense of a standalone AI diagnostic tool. Its "performance" refers to the quality of the images it produces and its ability to detect radioisotope uptake. The document indicates that "performance validation testing conducted according to NEMA NU-1:2012," which are standards for performance measurements of SPECT systems. This would refer to the technical performance of the device itself.

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

This information is not explicitly stated in the provided text. For SPECT imaging systems, ground truth for performance testing typically involves phantoms with known activity distributions to assess resolution, sensitivity, uniformity, etc., and potentially clinical correlation for certain aspects of image quality, but the document does not specify the method used.

8. The sample size for the training set:

This information is not applicable/available. The D-SPECT Cardiac Scanner System is a hardware imaging device that uses reconstruction algorithms, but the text does not describe an AI/machine learning component that would require a "training set" in the context of device performance claims.

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

This information is not applicable/available for the reasons stated above.

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