The Multi-SPECT is intended for use as an accessory to an dual headed nuclear medicine gamma camera (for example - the ADAC Vertex Dual Headed Nuclear Medicine Camera). It is to be used to perform static, dynamic and/or gated Single Photon Emission Computed Tomography clinical nuclear medicine images of the heart. It is indicated for use to produce images showing the location and distribution of radioisotopes in the human body for interpretation by a physician.

Device Description

The product consists of two multi-pinhole collimators attached to the two heads of a dual headed gamma camera (eg ADAC (now Philips) Vertex Gamma Camera). The collimators are designed to perform myocardial perfusion studies. Each collimator consists of a 2 x 3 array of pinholes. Each pinhole is focused on the patient's heart, such that the radioisotope distribution in the heart is seen from 18 different view points. This multiplicity of views allows for tomographic reconstruction of the radioisotope distribution in the heart. Acquisition is done in list-mode, retaining position, energy and patient physiological data. The raw listmode data is framed and corrected for scatter, then reconstructed into a three dimensional matrix. It can then be analyzed by previously cleared software packages (eg Emory Cardiac Toolbox™ - K040141).

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and NEMA test results, rather than explicitly stating pre-defined "acceptance criteria" in a go/no-go fashion. However, the comparisons imply that the Multi-SPECT's performance should be at least comparable to and ideally better than the predicate devices, particularly in sensitivity and resolution.

Specification (Acceptance Criteria Implied)	Predicate 1: Engineering Dynamics Multiple Pinhole Tomographic Collimator (K790499; K791055)	Predicate 2: ADAC Vertex Gamma Camera (LEHR collimator) (K922080)	Multi-SPECT (Reported Device Performance)	Conclusion for Acceptance Implied
Resolution (Point Source)	10.4 mm	11.0 mm	8.9 mm	Improved (Met/Exceeded)
Sensitivity (Point Source)	262 kcnts/min/mci	264 kcnts/min/mci	1118 knts/min/mci	Significantly Improved (Met/Exceeded)
NEMA 2.4 Resolution w/o scatter	Not available	10.0 mm	10.6 mm	Comparable (Met)
NEMA 2.6 Reconstruction resolution w/o scatter	Not available	11.0 mm	11.0 mm	Comparable (Met)
NEMA 3.7 Resolution with scatter	Not available	9.2 mm	10.4 mm	Comparable (Met)
NEMA 3.11 Resolution with scatter	Not available	15.4 mm	14.3 mm	Improved (Met/Exceeded)
NEMA 3.12 System Volume Sensitivity (normalized)	Not available	1	4.7	Significantly Improved (Met/Exceeded)
Mechanical System	Detectors move around patient, needs safety mechanisms	Detectors move around patient, needs safety mechanisms	Detectors stationary	Improved Safety (Met/Exceeded)
Sampling Field of View	Not available	180° / 0°	141° / 40°	Different configuration (Met)

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

Quantitative Performance: The "test set" for the quantitative performance metrics (resolution and sensitivity) consisted of NEMA NU 1 phantom(s) or equivalent, following NEMA guidelines. This is a standardized phantom, not a patient-specific dataset.
Clinical Images: "A set of three clinical images was also examined." The document does not specify the origin (country, retrospective/prospective) of these three clinical images. It's likely these were illustrative cases rather than a statistically powered clinical trial.
Data Provenance: Phantom data is laboratory-generated. The provenance of the three clinical images is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Quantitative Performance: For the NEMA phantom tests, the "ground truth" is inherent in the phantom's design and known properties, measured directly by the testing equipment. No human experts are explicitly mentioned for establishing this ground truth.
Clinical Images: The document mentions "A set of three clinical images was also examined." However, it does not state how the ground truth for these images was established, nor how many experts were involved or their qualifications. Given the small number, these were likely for visual inspection rather than a formal validation study with expert ground truth.

4. Adjudication Method for the Test Set:

Quantitative Performance: No adjudication method is specified for the NEMA phantom tests, as these are objective measurements.
Clinical Images: No adjudication method is described for the "set of three clinical images."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was NOT done. The submission focuses on demonstrating substantial equivalence through technical specifications and phantom studies, and a very limited review of three clinical images. There is no mention of human readers evaluating images with and without AI assistance to quantify improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in essence, standalone performance was assessed. The NEMA phantom tests and direct measurements of resolution and sensitivity are "standalone" in the sense that they evaluate the physical imaging system (collimator + gamma camera + reconstruction software) without human interpretation as the primary endpoint. The "algorithm" here refers to the entire imaging and reconstruction pipeline.

7. The Type of Ground Truth Used:

Quantitative Performance: The ground truth for the quantitative NEMA phantom tests is the known physical properties of the phantom and the direct measurements derived from it.
Clinical Images: The type of ground truth for the "set of three clinical images" is not specified.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided. This device is a hardware accessory (collimator) and associated reconstruction software algorithms. The document does not describe the use of machine learning or deep learning models that would typically require a training set of images with established ground truth. The reconstruction software uses "underlying mathematical algorithms" which are likely model-based or analytical, not learned from a large dataset in the way modern AI is trained.

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

Not Applicable / Not Provided. As per point 8, there's no indication of a training set or a machine learning approach in the sense that would require image data with established ground truth for model training. The algorithms are based on established mathematical principles for SPECT reconstruction that incorporate pinhole geometry.

Summary

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510(k) Summary

NOV -- 6 2007

A. Submitted By: Eagle Heart Imaging, LLC. 8407 Bryant St. Westminster, CO 80031
- John Koss Contact: 303-427-2289 Tel. Fax: 303-426-8688 E-mail: EagleHeartImaging@comcast.net

Date Prepared:

August, 2007

B. Device Trade Name: Multi-SPECT Common Name: Collimator Device Class: 21CFR 892.1200, Class II Product Code: 90 KPS
C: Predicate Device(s):

Multiple Pinhole Tomographic Collimator Engineering Dynamics Corp. (K790499); ADAC Tomography Option (K791055)

This collimator was used as an add on accessory to single headed gamma cameras such as the Picker Dynacamera 4/15, Ohio Sigma 410, or the Siemens LFOV.

Vertex Dual Headed Gamma Camera

ADAC Laboratories (K922080)

The detectors from this camera are used with the new device. Cardiac images from this camera are of typical quality for current SPECT cameras.

AutoSPECT

ADAC Laboratories (K992317)

This software package reconstructs the views acquired by a SPECT system into a 3 dimensional array for data analysis and display.

D: Device Description:
The product consists of two multi-pinhole collimators attached to the two heads of a dual headed gamma camera (eg ADAC (now Philips) Vertex Gamma Camera). The collimators are designed to perform myocardial perfusion studies. Each collimator consists of a 2 x 3 array of pinholes.

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Each pinhole is focused on the patient's heart, such that the radioisotope distribution in the heart is seen from 18 different view points. This multiplicity of views allows for tomographic reconstruction of the radioisotope distribution in the heart. Acquisition is done in list-mode, retaining position, energy and patient physiological data. The raw listmode data is framed and corrected for scatter, then reconstructed into a three dimensional matrix. It can then be analyzed by previously cleared software packages (eg Emory Cardiac Toolbox™ - K040141).

The collimators can be stored in the standard collimator storage device shipped with the camera and exchanged either manually or semiautomatically depending upon the configuration of the original dual headed gamma camera. When changing collimators, the operator needs to activate the pre-programmed exchange motion program. The program prompts the operator to proceed through the steps necessary for the exchange, and provides cautionary warnings to the operator during critical steps as a safety precaution. This is identical to changing the collimators that come standard on dual headed gamma cameras such as the Vertex.

When acquiring data, there is no motion of the camera. The camera heads can only be moved by the operator manually overriding the acquisition program.

E: Intended Use:
The Multi-SPECT is intended for use as an accessory to a dual headed nuclear medicine camera such as the ADAC Vertex Dual Headed Nuclear Medicine Camera. It is to be used to perform static, dynamic and/or gated Single Photon Emission Computed Tomography clinical nuclear medicine images of the heart. It is indicated for use to produce images showing the location and distribution of radioisotopes in the human body for interpretation by a physician.
F-Comparison to Predicate Device(s): The Multi-SPECT has the same intended use, target population, and clinical setting as other SPECT cameras including the predicate devices.
It uses the same technology as the predicate device Engineering Dynamics Multiple Pinhole Tomographic Collimator and the ADAC Laboratories Tomography Option, but adds an additional collimator and more pinholes, resulting in more views and an improved sampling geometry of the heart. Due to the additional views, the sensitivity is greater and the resolution of the reconstructed images is both higher and more uniform.

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It uses predicate device ADAC Laboratories Vertex Camera for the data acquisition. Replacing the parallel hole collimator on the Vertex Camera with the Multi-SPECT pinhole collimator results in images with comparable resolution but with increased sensitivity.

Reconstruction software uses the same underlying mathematical algorithms as the predicate AutoSPECT package, but incorporates the pinhole geometry. The overall result is that the Multi-SPECT has improved sensitivity and resolution over the Engineering Dynamics Pinhole Tomographic Collimator and ADAC Laboratories Tomography Option; and has improved sensitivity with equivalent resolution to rotational SPECT cameras such as the ADAC Vertex Camera.

Since motion of the detectors during acquisition is removed, the Multi-SPECT raises no new issues of safety or effectiveness; in fact with the motion disabled, safety is increased.

Specification	EngineeringDynamicsMultiple PinholeTomographicCollimator(Predicate 1)K790499;K791055	ADAC VertexGamma Camera(LEHRcollimator)(Predicate 2)K922080	This application -Multi-SPECT
Number ofcollimators	1	2	2
Number ofpinholes	7	NA (parallelhole)	18
Resolution1	10.4 mm	11.0 mm	8.9 mm
Sensitivity1	262kcnts/min/mci	264kcnts/min/mci	1118knts/min/mci

Data was acquired at the focal distance for the pinhole collimators (203 mm for the Multi-SPECT and 130 mm for the 7 pinhole predicate device). Resolution and sensitivity vary as a function of distance from the collimator face. Data for the predicate Vertex with a LEHR collimator was also collected at 203 mm from the collimator face. Source was a Tc-99m point source.

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G: System Performance Test: Bench testing was performed using NEMA NU 1 phantom(s) or equivalent following NEMA guidelines. A set of three clinical images was also examined.
H: Conclusion:

Eagle Heart Imaging, LLC believes that the Multi-SPECT is substantially equivalent to the predicate devices based on intended usage (for cardiac studies), technology comparison and system performance.

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Specification(NEMA test results)	ADAC VertexGamma Camera(LEHR collimator)(Predicate 2) K922080	This application -Multi-SPECT
NEMA 2.4 Resolution w/oscatter (source placed 120mm from detector)	10.0 mm	10.6 mm1
NEMA 2.6 Reconstructionresolution w/o scatter	11.0 mm	11.0 mm
NEMA 3.7 Resolution withscatter (source placed 120mm from detector)	9.2 mm	10.4 mm
NEMA 3.11 Resolution withscatter	15.4 mm	14.3 mm
NEMA 3.12 System VolumeSensitivity (normalized)	1	4.7
Mechanical	Detectors movearound patient, needssafety mechanisms	Detectors stationary
Sampling Field of View(radial / longitudinal)2	180° / 0°	141° / 40°

Comparison Table of Multi-SPECT with Predicate Devices

Notes:

All measurements made with Tc-99m.

All resolution measurements are average FWHM (averaged in the 3 principal directions).

The Engineering Dynamics predicate (K790499) and ADAC Laboratories Tomography Option (K791055) were not listed in the above table. These predicates are no longer sold and the NEMA tests were not able to be run.

1 As should be discernable from the above tables, the system resolution for the Multi-SPECT collimator is highly dependent on the distance from the pinhole, due to the magnification properties of pinhole imaging. The reconstructed resolution numbers are more indicative of the system capabilities. It should also be noted

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that the Multi-SPECT resolution and sensitivity numbers can be changed by changing the pinhole diameter. The actual diameter was chosen to approximate the resolution of the predicate device while maintaining a sensitivity advantage.

2 The top value represents the viewing angle in the radial direction while the bottom value represents viewing angle in the caudal or cephalic directions. The Vertex with LEHR collimator is capable of a full 360° acquisition, but in day-today practice the majority of cardiology practices use only 180° acquisition.

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Image /page/6/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 an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2007

Eagle Heart Imaging, LLC % Mr. Morten Simon Christensen Staff Engineer & FDA Program Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131

Re: K073021

Trade/Device Name: Multi-SPECT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: October 25, 2007 Received: October 26, 2007

Dear Mr. Christensen:

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, 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 (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 C 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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Indications for Use

K073021 510(k) Number (if known):

Multi-SPECT Device Name:

Indications For Use:

Prescription Use V (Per 21 CFR. 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 807 Subpart c)

(Please do not write below this line - continue on another page is needed)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Arzu Khhg

(Division Sign-Off)

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

4.1

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.