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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criterion (Implicit)	Reported Device Performance (Thick Crystal Option)
Technological Characteristics Identical to Predicate Device (SPECTRADigital™ Series V250DSP cleared under K954129)	"Identical to the predicate device"
Imaging Performance using NEMA NU1-1994 standards comparable to predicate device (SPECTRADigital™ V250DSP with 3/8" crystal)	Compared to the standard SPECTRADigital™ V250DSP system with 3/8" crystal system cleared under K954129 utilizing NEMA NU1-1994 standards.
Ability to acquire SPECT, planar, and wholebody imaging of all organ systems utilizing FDA approved radiopharmaceuticals in the energy range from 50 to 511 keV.	Confirmed for the thick crystal option, identical to the predicate device. Enhanced efficiency for higher energy applications due to thicker crystal.
Imaging capabilities (e.g., matrix-based spatial framed, temporal/spatial list mode, angular projection mode, dynamic planar and SPECT)	Confirmed, identical to predicate, with specific mention of performance for Coincidence and transmission-based imaging options (though these are separate).
Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.	Confirmed for the thick crystal option.

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.

Summary

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MAY 1 3 1539

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters. The sequence appears to be "K991129". The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses.

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

March 29, 1999

2.0 DEVICE NAME: SPECTRADigital™Series V250DSP Gamma Camera System Classification Panel: Radiology Classification Name: System, Tomographic, Nuclear 892.1310 90JWM Classification Number: Hitachi SPECTRADigital™ V250DSP Trade/Proprietary Name: Gamma Camera System with thick Nal(TI) crystal
Predicate Device: SPECTRADigital™ Series V250DSP cleared under K954129 and other gamma camera systems cleared with 5/8" crystals

3.0 Device Description

Function

The software did not need to ne modified or revised to support this option.

Scientific Concepts:

Diagnostic Nuclear Medicine began in the early 1950's with the availability of short half-life radioisotopes. Isotopes such as 1131 were injected into the patient and were selectively taken up by organ systems such as the thyroid.

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Measurement of the resulting radioactivity in the organ provided information on both the size of the organ and the relative amount of the isotope taken up.

Nuclear Medicine cameras work on a principle similar to television cameras. A collimator (lens) "focuses" gamma rays on a scintillation crystal. The scintillation crystal converts the gamma rays into light. Photomultiplier tubes are then used to convert the light into an electrical signal proportional to the energy of the detected gamma ray. Early instruments used a single hole lead collimator and detector that was moved in a raster pattern forming a 2-D image of the organ of interest. In the late 1950's methods were developed for directly obtaining a 2-D image by using a large crystal with multiple photomultiplier tubes and electronically calculating the position and energy of the gamma event.

dimensional projections collected at many positions can be Two mathematically combined to yield a three dimensional representation of the data. This principle of tomographic reconstruction was discovered early in this century, but it was not until the advent of high speed digital computer that the technique could be successfully applied in diagnostic imaging first to CT then to Nuclear Medicine and MRI.

Physical And Performance Characteristics:

Nuclear Medicine is currently of great interest because of its high contrast, and relatively low cost per study. The ability to attach radioisotopes to substances that are selectively taken up by specific tissue types can provide very high contrast between the tissue or organ of interest and surrounding tissue. This has tended to compensate for the relatively poor spatial resolution of Nuclear Medicine compared to other modalities such as MRI.

In addition the uptake and clearing of the radioisotopes can be observed temporally, providing an indication of the biological activity of the tissue. This is important when attempting to determine tissue viability, or finding areas of abnormal activity such as cancerous tissue.

4.0 Device Intended Use:

The intended uses of the SPECTRADigital™ V250DSP with 5/8" crystal option is identical to the SPECTRADigital™Series V250DSP cleared under K954129.. SPECT images are acquired over 360 decrees of orbit and transferred to a computer for processing. With 90° detector mechanical positioning in addition to standard 180° opposed positioning, cardiac SPECT imaging can be acquired with added efficiency during 180° orbit acquisition. Wholebody (head to foot) images are key applications of the SpectraDigital™ systems due to their large rectangular fields of view. Organ systems are imaged to assist in the determination of functional or pathological disorders including those affecting: Brain, Bone, Heart, Liver, Renal, Lung, Thyroid, Gallbladder, Pancreas, Testicular, and circulatory systems. Some diseases or pathology defined using customary techniques and industry approved radiopharmaceuticals include oncologic (cancer), bloodflow, tissue viability, TIA, infarction, embolism,

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thyroiditis, cirrhosis. The addition of thicker Nal(TI) crystal increases the detection efficiency for higher energy applications.

5.0 Device Technological Characteristics:

ldentical to the predicate device

6.0 Testing and Equivalence

Hitachi Medical believes the SPECTRADigital™ Series V250DSP to be substantially equivalent to Gamma Camera Systems currently in commercial distribution in the U.S. We have compared the Hitachi SPECTRADigital™ V250DSP Gamma Camera System with thick Nal(TI) crystal to the standard SPECTRADigital™ V250DSP system with 3/8" crystal system cleared under K954129 utilizing NEMA NU1-1994 standards

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1999

Gary W. Enos General Manager Hitachi Medical Corporation of America Nuclear medicine Products Division 9177 Dutton Drive Twinsburg, Ohio 44087

Re:

K991129 SPECTRADigital Series V250DSP Gamma Camera System Thick Crystal Option Dated: March 29, 1999 Received: April 2, 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 III (Special Controls) or dass 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

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510(k) Number (if known): K 991129

Device Name: Hitachi SPECTRADigital™ V250DSP Gamma Camera System with thick (5/8") Nal(TI) crystal

Indications For Use:

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

All SPECT and Planar procedures in common practice including matrix 트 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 트
트 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)
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)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991129

Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)

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.