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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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Intended uses of Convergences™ NUA® for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is identical to the ADAC Vantage ExSPECT 2.1 cleared under K971878 in system function and operational software. These include:

• Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data.
• Reconstruction of transmission and emission SPECT data via FBP and/or ML-EM/OSEM reconstruction methods
• Analysis and generation of attenuation maps and coefficients to apply to emission SPECT slice/volume sets.

The acquisition of SPECT is as cleared under SPECTRADigital™Series V250DSP system K954129, with addition of transmission acquisition protocols to produce images which depict anatomical density of a patient. The device is intended to provide an enhancement to the emission images acquired SPECTRADigital™ Series V250DSP by correcting for attenuation and scatter effects in the patient. When resulting images are interpreted by a trained physician, the information provided can be useful in the diagnosis determination.

Hitachi capabilities with with with with and Convergence SM NUA SM for for lmaging SPECTRADigital™ V250DSP Gamma Cameras option include:

• I 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
• 트 High and normal count-rate dynamic and non-temporal SPECT
• 트 In conjunction with additional options for Coincidence based imaging, the detector performance and NUA®ª acquisition and processing characteristics are available for non-uniform attenuation SPECT, attenuation correction in CID and CID based ECT imaging (these options are covered under separate and exclusive PMAs)
• I Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.

Convergence 3M NUA 3M for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is an optional Attenuation Correction Device (ACD) that provides capability to map anatomical information using external radioactive line source transmission, analyze densities and assign patient specific attenuation coefficients to minimize distortion caused by false information in the emission computer tomographic images due to overlying tissue and undesired scattered photons. The device is a combination of hardware and software to provide transmission, collimation, acquisition and analysis/correction of ECT data.

The Hardware which consists of a single, non-moving line source holder equipped with shutter, special line source slat collimation to minimize patient exposure and axial scatter and fan beam collimation. The standard source is Gadolinium 153 (240.4d T1/2, 97.4~103.2 keV, while the system has been confirmed with Technetium 99m ( 6hr T1/2, 140.5 keV) and Cerium-139 (137.6d T1/2, 165.8 keV).

The software consists of camera based transmission acquisition control and workstation based OSEM iterative and/or FBP (Filtered Back-Projection) reconstruction, coefficient determination and correction to ECT slice data. The system uses the same camera mechanical platform, table, collimators, electrical system and acquisition/system operating software cleared under K954129, with the addition of acquisition/processing sequences to correct for scatter and effects of attenuation. The acquisition of transmission and emission data is performed via fast sequential orbit acquisition to minimize effects of cross-spill and cross falk.

The provided document is a 510(k) submission for the Hitachi Medical Corporation's Convergence SM NUA SM for Hitachi SPECTRADigital™ V250DSP Gamma Cameras. This device is an optional Attenuation Correction Device (ACD). The document focuses on establishing substantial equivalence to a predicate device rather than providing detailed performance studies against specific acceptance criteria.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study results, sample sizes, expert qualifications, and ground truth establishment is not explicitly present in the provided text. The document refers to "clinical tests" and "phantom processed studies" but does not provide the details requested.

However, based on the available information, here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit quantitative acceptance criteria or detailed performance metrics are provided in the document. The evaluation relies on establishing substantial equivalence to a predicate device (ADAC Vantage ExSpect 2.1 system cleared under K971878) and verifying proper operation through specific tests.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "phantom processed studies" (using Data Spectrum Anthromophic Phantom, Data Spectrum Delux 5000 SPECT Phantom, Data Spectrum Cardiac Phantom, and NEMA Scatter Phantom) and "clinical tests," but does not provide the number of cases or subjects for these tests.
• Data Provenance: Not explicitly stated. Clinical data is implied to be from patient studies, but the country of origin or whether it was retrospective or prospective is not mentioned. Phantom studies are laboratory-based.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states that when resulting images are interpreted by a "trained physician," the information can be useful in diagnosis. However, it does not detail the use of experts to establish ground truth for the device validation itself.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: Not explicitly mentioned or detailed. The document states the device provides an "enhancement" to emission images and that the information can be useful in diagnosis when interpreted by a trained physician. However, it does not provide an effect size comparing human readers with AI assistance versus without AI assistance (as this is an attenuation correction device, not an AI interpretation tool in the modern sense).

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Implied. The phantom studies and simulations ("code implementation, simulation and phantom processed studies") assess the device's ability to operate properly and as intended in determining attenuation coefficients and correcting images. While human interpretation is mentioned for diagnosis, the core function of the Attenuation Correction Device itself (mapping anatomical information, analyzing densities, assigning attenuation coefficients, and correcting ECT slice data) is described as being tested and proven effective.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • For phantom studies: The "ground truth" would be the known physical properties and activity distributions within the phantoms.
  • For clinical tests: The document does not explicitly state how ground truth was established for clinical effectiveness. It refers to "effective application and expected results consistent with predicate devices." This implies a comparison to established clinical outcomes or expert judgment, but no specific method (e.g., pathology, outcomes data, expert consensus on uncorrected vs. corrected images) is outlined.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable/Not mentioned. This device utilizes established scientific concepts and algorithms (OSEM iterative reconstruction, FBP, fan beam acquisition, scatter window sampling) for attenuation correction rather than a machine learning model that would typically require a distinct training set. The "code implementation, simulation" refers to verification of the implemented algorithms, not training a model from data.

9. How Ground Truth for Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of a distinct training set in the context of machine learning. The algorithms are based on scientific principles of physics and image reconstruction.

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The SPECTRADigital™ Series V250DSP system with 5/8" crystal option are identical to the intended uses of the SPECTRADigital™Series V250DSP camera cleared under K954129 including acquisition of SPECT, planar, and wholebody imaging of all organ systems utilizing FDA approved radiopharmaceuticals in the energy range from 50 to 511 keV. When resulting images are interpreted by a trained physician, the information provided can be useful in the diagnosis determination.

Imaging capabilities with the Thick Crystal (5/8") Nal(TI) option include:

• All SPECT and Planar procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling
• High and normal count-rate dynamic planar and SPECT
• In conjunction with additional options for Coincidence and transmission based imaging, the detector performance and characteristics are available for non-uniform attenuation SPECT, attenuation correction in CID and CID based ECT imaging (these options are covered under separate and exclusive PMAs)
• Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.

The SPECTRADigital™ series gamma camera systems are area detectors designed to detect gamma rays emitted from the decay of radioisotopes injected into a patient. The position of the decay is calculated (a ray from the event to the detector) by the system, and stored. The positions of a large number of decay events forms an electronic image of the location of the radioactive material. This image can be displayed on a CRT or transferred to photographic film for review. The collection of data at multiple detector positions allows three dimensional information to be obtained by tomographic means. The addition of thicker Nal(TI) crystals enhance efficiency of detection at higher energies with minimal loss of imaging performance over energy ranges used routinely.

The provided text is a 510(k) summary for the Hitachi SPECTRADigital™ V250DSP Gamma Camera System with a thick NaI(Tl) crystal. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and human reader performance.

Here's an analysis based on the information provided, highlighting why some requested sections cannot be fully addressed:

Device: Hitachi SPECTRADigital™ V250DSP Gamma Camera System with thick NaI(Tl) crystal

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of thresholds for clinical performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing technical performance characteristics under NEMA NU1-1994 standards.

Summary of the study that "proves" the device meets acceptance criteria:

The study conducted was a technical comparison against a predicate device using the NEMA NU1-1994 standards. This is a non-clinical, bench-top type of evaluation, rather than a clinical trial assessing patient outcomes or diagnostic accuracy with human readers. The core of the argument for acceptance is that the new device (with the thicker crystal) maintains the same fundamental technology and offers comparable, or improved (for higher energies), performance characteristics as the already cleared predicate device.

2. Sample size used for the test set and the data provenance

• Test Set Description: The "test set" in this context refers to the measurements and characterizations performed on the gamma camera system according to NEMA NU1-1994 standards, rather than a set of patient cases.
• Sample Size: Not applicable in the sense of patient cases. The evaluation involved testing the physical and performance characteristics of the device itself.
• Data Provenance: The NEMA NU1-1994 standards are general industry standards for performance measurements of gamma cameras. The tests were likely performed in a laboratory setting by Hitachi Medical Corporation. The document does not specify the country of origin of the data beyond "Hitachi Medical believes..." implying internal testing. It is a prospective technical evaluation of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a technical comparison of device performance against a predicate and industry standards, not a clinical study requiring expert interpretation of medical images to establish ground truth about patient conditions.

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

Not applicable. There was no clinical ground truth requiring adjudication by experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed.
• Effect Size: Not applicable. This device is a gamma camera system, a hardware device for acquiring images, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. The device itself (gamma camera) has standalone performance in terms of image acquisition, but this is characterized by technical specifications using NEMA standards, not an "algorithm only" performance. There is no AI algorithm being evaluated here.

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

The "ground truth" for this submission is the NEMA NU1-1994 standards for gamma camera performance and the established performance of the predicate device (SPECTRADigital™ V250DSP with 3/8" crystal). The thick crystal option aims to achieve comparable performance, or improved detection efficiency for higher energies, while maintaining the predicate's overall characteristics.

8. The sample size for the training set

Not applicable. This is a hardware device submission, not a machine learning model. There is no training set in the AI/ML sense.

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

Not applicable, as there is no training set.

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