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510(k) Data Aggregation
(60 days)
CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effective application of attenuation correction | "Clinical tests have documented effective application and expected results consistent with predicate devices currently in commercial distribution." |
| Accurate determination of attenuation coefficients | "The results of transmission reconstruction and attenuation coefficient determination has proven effective." |
| Proper operation of acquisition, analysis, and correction | "In the code implementation, simulation and phantom processed studies, acquisition, analysis and correction results have been thoroughly tested and verified to operate properly and as intended." |
| Consistency with predicate device's system function and software | The intended uses are "identical to the ADAC Vantage ExSpect 2.1 cleared under K971878 in system function and operational software." |
| Emission, leakage, patient dose, and safe controls compliance | "In accordance with NUREG-1556 of the Nuclear Regulatory Commission for emitter source devices, the devices emissions, leakage, patient dose and safe controls are consistent with requirement and those of commercially approved devices." This refers to regulatory compliance rather than specific performance metrics of the attenuation correction itself. |
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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