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.

Device Description

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.

AI/ML Overview

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.

Summary

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JUN 18 1999

Attachment 1 Summary of Safety and Effectiveness

*Attachments labeled "CONFIDENTIAL" as follows: Hitachi Medical Corporation regards the information defined as part of this Attachment to be a trade secret and confidential in nature.

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1.0 Submitter Information

Hitachi Medical Corporation of America Nuclear Medicine Product Division 9177 Dutton Drive. Twinsburg, Ohio ESTABLISHMENT REGISTRATION NUMBER: 1530450 PH: 330-405-3330 FX: 330-405-3222

Contact Gary W. Enos

Date April 16, 1999

2.0 DEVICE NAME: Convergence SM NUA SM

Classification Panel: Radiology Classification Name: System, Tomographic, Nuclear Classification Number: 892.1200 90KPS Trade/Proprietary Name: Convergence sm NUA SM for Hitachi SPECTRADigital™ V250DSP Gamma Cameras

Predicate Device: ADAC Vantage ExSpect 2.1 system cleared under K971878

3.0 Device Description

Function

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attenuation. The acquisition of transmission and emission data is performed via fast sequential orbit acquisition to minimize effects of cross-spill and cross falk. A detailed description can be found in Attachment 1. Detailed device specifications can be found in Attachment 4.

Scientific Concepts:

Over lying anatomical structures of varied densities and in-patient scatter are known to cause distortion to the determination of radionuclide distribution(s) in-vivo. Spatial and contrast representation of radionuclide distribution is degraded by photon attenuation and scatter. Fixed geometrical and linear attenuation corrections (ie. Chang and Sorenson methods) are simple estimations. In addition, attempts to manage the effects of scatter via pre and/or post scatter sampled window subtraction techniques serve to perturb Poisson noise statistics and reconstruction weighting values contributive to tomographic results.

A more accurate method of attenuation and scatter correction has been the basis for patient specific transmission imaging and spectral scatter window sampling techniques. Fan beam acquisition and reconstruction is documented to improve geometrical sensitivity and resolution limited only by the intrinsic resolution of the camera system and the solid angle of the focal distance of the collimator. For transmission imaging, the diameter of the line source is an additional consideration to the resolution achievement potential. Utility of longer focal length symmetric fan beam collimation (77cm) positioned offset to the axis of rotation mimics asymmetric fan beam geometry, thereby markedly increasing the viewing volume to reduce potential for truncation.

In combination with Iterative ML-EM and OSEM reconstruction methods (known to accurately incorporate the Poisson nature of photon noise and a number of other relevant physical factors), improved tomographic results in terms of image contrast and quantitative accuracy are well documented via Monte-Carlo, phantom and real patient conditions. The combination of documented and proven Fan Beam acquisition and reconstruction and well collimated line source geometry, improvements in data acquisition density (Signal-to-Noise) and resolution input function provide an accurate basis for transmission and emission volume correlation.

The Convergence® NUA® for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is an Attenuation Correction Device (ACD) incorporates the applied improvements of offset fan beam (1/2 fan) acquisition/reconstruction, single line non-moving source, axial collimation, OSEM iterative reconstruction, scatter window sampled correction and density specific attenuation correction to emission ECT tomographic distributions.

5.0 Device Technological Characteristics:

Technologies associated with Convergence SM NUA sm for Hitachi SPECTRADigital™ V250DSP Gamma Cameras are defined in Attachment 4. Key elements include:

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Symmetric Fan Beam Collimation with a 77cm, focal length �
Utilization of offset fan beam parameters and detector/collimator orientation to � minimize truncation and increase viewing volume (increase the TCT FOV)
Axial collimated line source of NRC registered and approved sources in the � 1.5~3mm diameter range
Shutter controlled transmission with absorber plates to manage source strength, � transmission beam characteristics (area and profile)
� Sequentially acquired Transmission and Emission data to minimize cross contamination
Scatter window sampling to modulate transmission and emission data as part � of the reconstruction domain.
OSEM iterative reconstruction of transmission and emission data to maximize � resolution and quantification accuracy.
� Segmentation of anatomical regions and anatomical densities to correct attenuation effects in emission SPECT.

6.0 Testing and Equivalence

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. The results of transmission reconstruction and attenuation coefficient determination has proven effective. Clinical tests have documented effective application and expected results consistent with predicate devices currently in commercial distribution.

Medical believes the ConvergencesM NUA sM Hitachi for Hitachi SPECTRADigital™ V250DSP Gamma Cameras, an Attenuation Correction Device (ACD), to be substantially equivalent to Gamma Camera Systems currently in commercial distribution in the U.S. We have tested the Convergence SM NUA SM for Hitachi SPECTRADigital™ V250DSP Gamma Cameras with the Data Spectrum Anthromophic Phantom, Data Spectrum Delux 5000 SPECT Phantom, Data Spectrum Cardiac Phantom and NEMA Scatter Phantom to establish the basis for proper operation.

In accordance with NUREG-1556 of the Nuclear Requlatory Commission for emitter source devices, the devices emissions, leakage, patient dose and safe controls are consistent with requirement and those of commercially approved devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

JUN 18 1999

Gary W. Enos Hitachi Medical Corporation 9177 Dutton Drive Twinsburg, Ohio 44056

Re:

K991318 Convergence NUA for SpectraDigital V250DSP System Dated: April 16, 1999 Received: April 19, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Enos:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/4/Picture/14 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three abstract human profiles or faces, stacked on top of each other and connected by flowing lines.

Ke.

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510(k) Number (if known): K991318

Convergence SM NUA SM for Hitachi SPECTRADigital™ V250DSP Device Name: Gamma Cameras

Indications For Use:

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.

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓ OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)
(Division Sign-Off)	(Optional Format 1-2-96)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K991318

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.