The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.

Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

Device Description

The ClearVision Nuclear Medicine Imaging System acquires and processes cardiac data including gated and non-gated Single Photon Emission Computed Tomography (SPECT) studies. After completion of an acquisition, the operator can select the resulting acquisition data file to generate both qualitative and quantitative results for review by a physician. This includes processing using Release 5.6 of Segami Corporation's Mirage processing software that was previously cleared under 510(k) number K043441 dated 13-January-2005.

The acquisition system consists of either a single or dual small field-of-view detectors with each mounted on top of a tower that contains system electronics. To support the acquisition of SPECT data, the patient chair rotates up to 360 degrees in either clockwise or counterclockwise direction.

Prior to a patient scan, the following system features are used to ensure the myocardium is centered within each detector's field of view (FOV):

. Each tower can be moved horizontally along rails mounted to the floor plate.
. The patient chair seat pan can be moved side-to-side.
Vertical and a horizontal beam lasers are mounted to side of detector.

The ClearVision system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

AI/ML Overview

The provided document is a 510(k) summary for the GVI Medical Devices ClearVision Nuclear Imaging System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for the ClearVision system itself.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment is not available in this document. The document describes a comparison of features and performance characteristics to a predicate device (Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems, K070542) to establish substantial equivalence.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents a "Feature Comparison Summary" to demonstrate substantial equivalence to the predicate device. The performance characteristics listed are NEMA (National Electrical Manufacturers Association) standards, which are common for SPECT systems and implicitly serve as performance benchmarks.

Feature	Acceptance Criteria (Predicate)	Reported ClearVision Performance	Does it meet acceptance criteria?
NEMA Reconstructed Spatial Resolution	11.00 mm (for predicate)	9.8 mm (central), 7.6 mm (tangential), 8.4 mm (radial)	The ClearVision's spatial resolution values (smaller numbers indicate better resolution) are superior to the predicate's 11.00 mm, indicating it meets or exceeds this aspect.
NEMA System Sensitivity	160 cpm / uci (for predicate)	147 cpm / uci	ClearVision's sensitivity is slightly lower than the predicate, but this is presented in the context of substantial equivalence, implying it is within an acceptable range for the intended use given other features. The document explicitly states "performs as well as the predicate".
NEMA Energy Resolution	< 10.5 % (for predicate)	≤ 9.0 %	The ClearVision's energy resolution is better (lower percentage) than the predicate, indicating it meets or exceeds this aspect.
Energy Range	50 - 170 keV (for predicate)	90 – 160 keV	The ClearVision's energy range is narrower than the predicate, this is a difference in specification, but not framed as a failure to meet a criterion for substantial equivalence.
Small Detector UFOV	Yes (6.2" x 8.3")	Yes (8.5" x 8.5")	The ClearVision has a larger UFOV, which is generally a benefit, so it meets or exceeds this.

Note: The "Acceptance Criteria" column above is inferred from the predicate device's performance characteristics as presented for comparison in the document for demonstrating substantial equivalence.

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

Not Available. The document does not describe a clinical study with a specific test set, patient data, or data provenance (country of origin, retrospective/prospective). The comparison is based on technical specifications and performance characteristics from NEMA standards and device design.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Available. There is no mention of a human expert review or ground truth establishment process in the context of a clinical study in this document.

4. Adjudication Method

Not Available. As no expert review or human-in-the-loop study is described, no adjudication method is mentioned.

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

No. The document does not mention any MRMC comparative effectiveness study, nor any evaluation of human readers' improvement with or without AI assistance. The device is a SPECT imaging system, not an AI-assisted diagnostic tool in the sense of a software algorithm interpreting images.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly, for certain physical parameters. The performance characteristics listed (NEMA Reconstructed Spatial Resolution, NEMA System Sensitivity, NEMA Energy Resolution) are measures of the system's inherent physical performance, which can be considered "standalone" as they don't involve a human in the loop for the measurement itself. However, this is for the imaging system's hardware performance, not an "algorithm" in the sense of an AI model making diagnostic interpretations. The Segami Mirage processing software (Release 5.6) used for processing is mentioned as previously cleared (K043441), indicating its standalone processing capabilities were evaluated separately.

7. Type of Ground Truth Used

For the physical performance characteristics of the device, the "ground truth" is established through standardized phantom measurements according to NEMA (National Electrical Manufacturers Association) protocols. These are empirical measurements of physical performance metrics (e.g., resolution in mm, sensitivity in cpm/uci, energy resolution in %). For images generated, the ground truth for diagnostic interpretation would typically involve clinical data like pathology or patient outcomes, but this level of detail is not discussed for the ClearVision system in this document.

8. Sample Size for the Training Set

Not Applicable/Not Available. The ClearVision is a hardware device (SPECT scanner) combined with processing software. There is no mention of a "training set" in the context of machine learning. The system's design and engineering are based on established physics and medical imaging principles.

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

Not Applicable/Not Available. As there is no "training set" in the machine learning sense, there is no discussion of how ground truth for such a set was established.

Summary Explanation:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to an existing predicate device (Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems), rather than presenting a new clinical study with novel acceptance criteria and extensive human-in-the-loop performance evaluations. The document highlights the ClearVision's technical specifications and physical performance characteristics (e.g., NEMA standards) in comparison to the predicate, arguing that despite some differences (like detector technology and collimator type), it performs "as well as" the predicate and does not introduce new safety risks. This approach is common for demonstrating equivalence of medical devices, especially imaging hardware, where performance is often benchmarked against established industry standards and predicate device capabilities.

Summary

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B Administrative Information

K072191

OCT 2 5 2007

B.1 510(k) Summary of Safety and Effectiveness

Image /page/0/Picture/6 description: The image shows the logo of GVI Medical Devices, along with their address. The logo features an atom-like graphic with the letters "gvi" in a stylized font. Below the logo, the words "MEDICAL DEVICES" are printed in smaller letters. The address is "1470 Enterprise Parkway Twinsburg, OH 44087".

p. 330.963.4083
f. 330.963.4084
www.avimd.com

The following information is in accordance with 21 CFR 807.92.

B.1.1 Submitted By:
Name and Address:

Contact Person:
Telephone:
Fax:
E-mail:
Date Prepared:

B.1.2 Device Identification

Trade / Proprietary Name: Common Name: Classification Name: 21 CFR Number: CDRH Product Code: Regulatory Device Class: Classification Panel:

GVI Medical Devices 1470 Enterprise Parkway Twinsburg, Ohio 44087 Kevin Murrock 330-963-4083, x113 330-963-4084 mailto:kevin.murrock@gvitp.com 3-August-2007

ClearVision Nuclear Imaging System SPECT System System, Emission Computed Tomography 892.1200 90 KPS ll Radiology

B.1.3 Predicate Device Manufacturer: Digirad Corporation Trade Name: Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems 510(k) Number: K070542 CDRH Product Code: 90 KPS

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B.1.4 Device Description

Prior to a patient scan, the following system features are used to ensure the myocardium is centered within each detector's field of view (FOV):

. Each tower can be moved horizontally along rails mounted to the floor plate.
. The patient chair seat pan can be moved side-to-side.
Vertical and a horizontal beam lasers are mounted to side of detector.

The ClearVision system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

B.1.5 Intended Use

Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

B.1.6 Substantial Equivalence Comparison

The ClearVision is of a comparable type and substantially equivalent to the Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems (510(k) Number K070542), as both devices are used to acquire gated and non-gated SPECT studies using similar physical characteristics (refer to feature comparison summary table in Section B.1.7). In addition, the detector layout and electronics are identical in both physical and performance characteristics to the detector used on the GVI Medical Devices OnePass Nuclear Imaging System (510(k) K023373).

The primary difference between the ClearVision and the Cardius 1 and 2 XPO Systems is in detector technology and collimation. ClearVision uses traditional Anger technology detectors along with proprietary inverse fan-beam collimators, while the Cardius XPO systems use solidstate detectors and parallel-hole collimators. Refer to Attachment B for detailed description of the inverse fan-beam collimator.

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Feature	ClearVision	Cardius 1 and 2 XPO
Acquisition Types	SPECT and Gated SPECT	Same
Other Acquisition Types	None	Planar and Planar Gated
Number of Detectors	One or Two	One or Two
Detector Technology	Anger (33 photomultiplier tubes)	Solid-state
Crystal Material	Nal(TI)	Csi(TI)
Small Detector UFOV	Yes8.5" x 8.5" UFOV	Yes6.2" x 8.3" UFOV
Collimator	Inverse Fan-Beam	Parallel-Hole (LEHR)
NEMA Reconstructed SpatialResolution with Scatter	9.8 mm (central)7.6 mm (tangential)8.4 mm (radial)	11.00 mm
NEMA System Sensitivity	147 cpm / uci	160 cpm / uci
NEMA Energy Resolution	≤ 9.0 %	< 10.5 %
Energy Range	90 – 160 keV	50 - 170 keV
Patient Position	Upright Chair	Upright Chair
Patient Weight Limit	≤ 500 lbs.	Same
Motor Driven Motions	1) Detector Tower Horizontal2) SPECT Chair Rotation3) SPECT Chair Vertical	1) SPECT Chair Vertical2) SPECT Chair Rotation3) SPECT Chair Horizontal
System Mount	Secured directly to floor.	N/A
Small Room Size	Yes8' x 8'	Yes7.5' x 8.0"
Processing Functions	SPECT and Gated SPECT processing anddisplay, including SPECT reconstruction andcardiac reorientation.	SPECT, Gated SPECT, Planar, and Gated Planarprocessing and display, including SPECTreconstruction and cardiac reorientation.
SPECT Processing Software	Segami Mirage Release 5.6	Same

B.1.7 Feature Comparison Summary

B.1.8 Conclusion

The ClearVision does not pose any new potential safety risks and performs as well as the predicate Digirad Cardius 1 and 2 XPO Systems. Therefore, it is the opinion of GVI Medical Devices that the ClearVision is substantially equivalent in terms of safety and effectiveness to the legally marketed Digirad Cardius 1 and 2 XPO Systems for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three wavy lines representing the body and head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 25 2007

Mr. Kevin M. Murrock Manager, Quality & Regulatory GVI Medical Devices 1470 Enterprise Parkway TWINSBURG OH 44087

Re: K072191

Trade/Device Name: ClearVision Nuclear Medicine Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 3, 2007 Received: August 6, 2007

Dear Mr. Murrock:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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B.2 Indication for Use

Page 1 of 1

510(k) Number (if known): K072191

Device Name: ClearVision Nuclear Medicine Imaging System

Indication for Use: The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.

Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

Prescription Use
(21 CFR Part 801 Subpart D)

And/Or

Over-The-Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Halal Remmer

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

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.