The VCAR option to the DST Gamma Camera and VISION Powerstation and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation produce images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The systems are intended for whole body nuclear imaging.

Indication for use of the VCR option to the DST and DST-XL cameras and Powerstation computer is an accessory upgrade intended to perform electronic collimation for coincidence imaging of positron-emitting radioisotopes in the human body.

Device Description

The VCAR option to the DST Gamma Camera and VISION Powerstation (DST&PS/VCAR) and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation are accessory upgrades to the previously cleared DST an DST-XL Gamma Cameras (K921008) and VISION Powerstation (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The DST&PS/VCAR and DST-XL&PS/VCAR utilize proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT).

The DST&PS/VCAR and DST-XL&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The DST&PS/VCAR and DST-XL&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SMV America DS-VCAR Option 510(k) (K972686), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific pass/fail acceptance criteria values for performance metrics. Instead, it makes a general claim of meeting "system performance specifications" and performing "in a fashion similar to predicate devices."

Acceptance Criteria (Implied)	Reported Device Performance
Meets System Specifications	"The VCAR option... was developed and validated in accordance with the Company's product and software development procedures. System testing and validation demonstrates that the system meets its published specifications..."
Performs Similar to Predicates	"Major performance parameters have been measured using industry-standard test methods to determine that the device... performs in a fashion similar to predicate devices." "The DST&PS/VCAR and DST-XL&PS/VCAR have been designed to perform imaging of PET isotopes in a way which is very similar to traditional PET systems (e.g., the GE Quest 300) and gamma camera PET systems (e.g., SMV's VCAR option to the FX-80 Gamma Camera and Power Station, and ADAC's MCD option to the VERTEX Epic System). The DST&PS/VCAR and DST-XL&PS/VCAR is very similar to all three predicate devices." "System testing and validation demonstrates that the system... performs as well as or better than the currently marketed product..." (referring to implicitly predicate devices or previous versions of their own product).
Safe and Effective	"...and is safe and effective for its intended use."

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

The document does not specify a sample size for a test set in terms of cases or patients. It mentions that "Major performance parameters have been measured using industry-standard test methods," implying laboratory or phantom-based testing rather than studies involving patient data for a test set. There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective) for any clinical or test data.

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 testing described appears to be technical performance validation against specifications and predicate devices, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The document describes technical performance testing rather than a study requiring adjudication of clinical interpretations.

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

The document does not describe an MRMC comparative effectiveness study. There is no mention of human readers, AI assistance, or an effect size for human improvement. The focus is on the device's technical performance and equivalence to predicate devices.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The document describes standalone performance in terms of the device's technical capabilities. The "Summary of Testing" states that "Major performance parameters have been measured using industry-standard test methods to determine that the device meets its system performance specifications and performs in a fashion similar to predicate devices." This implies testing of the device's imaging and reconstruction capabilities in isolation.

7. Type of Ground Truth Used

The ground truth for the testing appears to be based on industry-standard test methods and published specifications for gamma cameras and PET systems, rather than clinical ground truth like pathology or outcomes data. The comparisons are made against established performance characteristics of predicate devices.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is expected as the device predates modern machine learning/AI paradigms that typically rely on large training datasets. The "VCAR option" appears to be an accessory upgrade that utilizes coincidence detection electronics and software for image processing and reconstruction, not a deep learning model.

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

Since there is no mention of a training set in the context of machine learning, the question of how its ground truth was established is not applicable. The development and validation were "in accordance with the Company's product and software development procedures," implying traditional engineering and software verification methods.

Summary

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K972686

SMV America DS-VCAR Option 510(k)

Appendices Page 45 of 48

Appendix X

OCT 1 4 1997

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

August 20, 1996 Prepared:

SMV America Submitter : 8380 Darrow Rd. Twinsburg, Ohio 44087 (800) 664-0844
Contact: W. Bishop VP Business Development
System, Emission Computed Tomography Classification Name: Device: 90 KPS Classification Number: Coincidence Imaging Gamma Camera System Common or Usual Name: VCAR option to DST Gamma Camera and VISION Trade/Proprietary Name: Powerstation VCAR option to DST-XL Gamma Camera and VISION Powerstation

Predicate Devices:

SPONSOR	PRODUCT	PreamendmentStatus or 510(k)Number
SMV America.	VCAR option to FX-80&PS	K963273
UGM Medical Systems, Inc.	Penn-PET(marketed as GE Quest 300)	K930428
ADAC Laboratories	MCD option to VERTEX EpicSystem	K952684

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Device Description Summary:

The VCAR option to the DST Gamma Camera and VISION Powerstation (DST&PS/VCAR) and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation are accessory upgrades to the previously cleared DST an DST-XL Gamma Cameras (K921008) and VISION Powerstation (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The DST&PS/VCAR and DST-XL&PS/VCAR utilize proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT).
The DST&PS/VCAR and DST-XL&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The DST&PS/VCAR and DST-XL&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.

Intended Use:

? 52 €

The VCAR option to the DST Gamma Camera and VISION Powerstation and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation produce images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The systems are intended for whole body nuclear imaging.

Technological Characteristics:

The DST&PS/VCAR and DST-XL&PS/VCAR have been designed to perform imaging of PET isotopes in a way which is very similar to traditional PET systems (e.g., the GE Quest 300) and gamma camera PET systems (e.g., SMV's VCAR option to the FX-80 Gamma Camera and Power Station, and ADAC's MCD option to the VERTEX Epic System). The DST&PS/VCAR and DST-XL&PS/VCAR is very similar to all three predicate devices.
Each system detects radioisotope emissions from the human body and integrates the acquired emission data over time to produce an image representing a quantification of emissions from the imaged region. All three units utilize the same theory of operation.
In all three systems, detection events from opposing detectors are compared, to determine if both detected an event almost simultaneously. Coincident events undergo additional processing to generate images which show the frequency of annihilation events due to radioisotopes in the area being imaged.
Each of the three systems have additional post-acquisition processing systems which further manipulate the image data to perform 2-dimensional and 3 dimensional reconstructions of the imaged area.

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In addition, all three systems are able to utilize any FDA-approved positron-emitting radioisotope (e.g., Fluorodeoxyglucose [FDG] ) to generate images.

Summary of Testing:

Major performance parameters have been measured using industry-standard test methods to determine that the device meets its system performance specifications and performs in a fashion similar to predicate devices.

Conclusion:

The VCAR option for the DST and DST-XL Gamma Cameras and VISION Powerstation was developed and validated in accordance with the Company's product and software development procedures. System testing and validation demonstrates that the system meets its published specifications, performs as well as or better than the currently marketed product, and is safe and effective for its intended use.

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Image /page/3/Picture/17 description: The image shows a logo for the Department of Health. The logo features a stylized representation of three human profiles facing to the right, stacked slightly on top of each other. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the logo, with the letters oriented to be read from bottom to top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

OCT 1 4 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

William Bishop Vice President of Business Development SMV America 8380 Darrow Road Twinsburg, OH 44087

Re: K972686

VCAR option to the DST and DST-XL Gamma Cameras and VISION Powerstation Computer Dated: July 16, 1997 Received: July 17, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Bishop:

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 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 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 requirement, 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 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.html".

Sincerely yours,

h.Liau Yu

Lillian Yin, Ph.D. 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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Page__of_l

Labels	Values
510(k) Number (if known):	K-972686
Device Name:	VCAR option to DST & DST-XL Gemma Cameras and Vision Powerstation computer.

Nuclear Medicine Device

Indication For Use: To detect or image the distribution of radionuclides in the body or a organ, using the following technique(s).

	YES	Energy Range (keV)
A. Planar imaging	X	60 - 560 keV
B. Whole body imaging
C. Tomographic imaging (SPECT) for non Positron emitter
D. Positron imaging by coincidence	X	60 - 560 keV
E. Positron imaging without coincidence
F. Other indication(s) in the device label, but not included in above list	Indication for use of the VCR option to the DST and DST-XL cameras and Powerstation computer is an accessory upgrade intended to perform electronic collimation for coincidence imaging of positron-emitting radioisotopes in the human body.

(P ease do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

I Tescription I ise_ (Per 2 | CFR 801.109)

Over-the-Counter Use,

(Optional Formal 1-2-96)

David A. Seysom

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K1716610

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.