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Intended uses of Convergence™ CDR®M for Hitachi SPECTRADigital™V250DSP Gameras is identical to the principle of coincidence imaging used by EPIC-MCD Cleared under K952684, ADAC MCD-AC cleared under K971980 in intended use, methods, reconstruction algorithms, transmission source type, and effectiveness of application. These include:

• Acquisition of patient specific biodistribution of positron-emitting radioisotopes in-vivo.
• Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data.
• Reformation of coincidence data to images frames with subsequent reconstruction of transmission and Wholebody ECT data via FBP and/or ML-EM/OSEM reconstruction methods.
• Analysis and generation of attenuation maps and coefficients to apply to emission ECT slice/volume sets.

Convergence sm for for Hitachi with Imaging capabilities SPECTRADigital™ V250DSP Gamma Cameras option include:

• All SPECT procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling
• Use in conjunction with FDA approved 511 keV emitting radiopharmaceuticals
• High and normal count-rate dynamic and non-temporal ECT
• In conjunction with Coincidence based imaging, the detector performance and NUA® acquisition and processing characteristics are available for non-uniform attenuation ECT, attenuation correction in CID and CID based ECT imaging.
• Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.

CONVERGENCE®M CDR §™ for Hitachi SPECTRADigital™ V250DSP Gamma Cameras, cleared under K954129 is an Coincidence Imaging Device (CID) option that provides capability to acquire 511 keV coincidence events and form images in 1D, 2D and 3D modes of operation. With the addition of ATTCOR, non-linear scaled low energy transmission correction utilizing NUA88 submitted under K991318) mapping of anatomical information using external radioactive line source transmission with analysis of densities and assignment of patient specific attenuation coefficients to minimize distortion due to overlying tissue and undesired scattered photons. The device is a combination of hardware and software to provide detection, decoding, image formation with corrections and Whole body and tomographic reconstruction. When the system is equipped with thicker 5/8" crystals submitted under K991129, the V250DSP efficiency for 511 keV events is improved.

The additional Hardware which consists of Aperture Grids with graded absorbers, high speed pre-amps with coincident signal timing, high speed decoding and correction circuitry and acquisition control software. 1-D framing at the camera system is provided and 2-D, 3-D frame formation via workstation based FORE (Fourier Rebinning) and OS-EM processes. When equipped with ATTCORSM, a single, non-moving line source holder equipped with shutter, special line source slat collimation to minimize patient exposure and axial scatter and non-linear scaling processing is provided. The software consists of FORE rebinning. OSEM iterative and/or FBP (Filtered Back-Projection) reconstruction, transmission acquisition control and coefficient determination in the correction to ECT slice data per NUASM submitted under K991318.

The provided document describes a 510(k) premarket notification for the "Convergence SM CDR SM for Hitachi SPECTRADigital™ V250DSP Gamma Cameras," a Coincidence Imaging Device (CID) option. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a detailed clinical study with statistical endpoints.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or a detailed performance table in the typical sense of a clinical trial. Instead, it asserts that the device has been "thoroughly tested and verified to operate properly and as intended" and that the "results of transmission reconstruction and attenuation coefficient determination has proven effective." It also mentions "Clinical tests have documented effective application and expected results consistent with predicate devices currently in commercial distribution."

The primary performance claim is substantial equivalence to predicate devices. The testing that was conducted was to "establish the basis for proper operation" and included phantom studies.

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

• Sample Size: The document does not specify a "sample size" in terms of patient cases for clinical testing. For phantom testing, it states the device was tested with the Data Spectrum Delum 5000 Phantom, Data Spectrum PET Phantom, and NEMA Scatter Phantom.
• Data Provenance: The document mentions "Clinical tests have documented effective application," but provides no details on the origin, retrospective/prospective nature, or location of these clinical tests. The phantom studies are likely internal testing.

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

• This information is not provided in the document. The "clinical tests" are mentioned vaguely, but no details on expert involvement or ground truth establishment are given. The phantom studies use physical phantoms as their "ground truth".

4. Adjudication Method for the Test Set:

• This information is not provided. Given the nature of a 510(k) supporting substantial equivalence, a formal adjudication process with multiple experts for a clinical dataset is typically not the primary method of evaluation described in these types of submissions, unless it's a more complex diagnostic algorithm.

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

• No, an MRMC comparative effectiveness study is not mentioned. The document states that "Clinical tests have documented effective application and expected results consistent with predicate devices," but this does not describe an MRMC study comparing human readers with and without AI assistance. The focus is on the device's inherent functionality and equivalence, not reader performance.

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

• Yes, a form of standalone testing was done. The phantom studies ("code implementation, simulation and phantom processed studies") assess the algorithm's performance in generating images and performing corrections without direct human interpretation in a comparative effectiveness setting. The device itself (the hardware and software) is the "standalone" entity here, performing image acquisition, processing, and reconstruction.

7. The Type of Ground Truth Used:

• For the phantom studies, the ground truth is the known physical properties and characteristics of the phantoms (e.g., known activity distributions, anatomical structures, scatter properties).
• For the "clinical tests," the type of ground truth and how it was established is not specified.

8. The Sample Size for the Training Set:

• This document describes a device (hardware and software) for image acquisition and reconstruction, not a machine learning algorithm that requires a "training set" in the modern sense of supervised learning. Thus, the concept of a training set sample size is not applicable here. The software components like OSEM and FBP are well-established reconstruction algorithms, not models trained on large datasets.

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

• As the concept of a training set is not applicable (see point 8), this information is not provided and not relevant to this specific device submission.

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