The Hawkeye Option is an addition to the Apex VariCam / Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation and to facilitate localization of the emission images in the patient anatomy.

AI/ML Overview

The provided 510(k) summary for the Hawkeye Option for Dual-Head Variable Angle Gamma Camera (K991841) is very brief and lacks detailed information about specific acceptance criteria and the comprehensive study design.

Here's an analysis based on the available text, addressing your points as much as possible, and noting where information is not provided:

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics. Instead, it offers a qualitative summary.

Acceptance Criteria (Stated/Implied from Summary)	Reported Device Performance
Attenuation Correction: Producing images that are "more uniform" than uncorrected NM images.	"clinical data show that Hawkeye attenuation-corrected images are more uniform than NM images without attenuation correction."
Localization: Enabling the localization of emission images in patient anatomy.	"The images also demonstrate the localization capabilities of the Hawkeye."
Substantial Equivalence: In terms of safety and effectiveness to predicate devices (VTransACT and Advanced Analysis Software).	The conclusion states the device "is substantially equivalent in terms of safety and effectiveness" to the predicate devices.

Study Details

Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document refers to "clinical data" but does not specify the number of patients, scans, or their origin, nor whether the study was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. There is no mention of experts or how ground truth was established for "uniformity" or "localization capabilities." Given the nature of the device (image correction and display), it's possible that the "ground truth" for uniformity was visual assessment or phantom studies, and for localization, it might have involved co-registration with anatomical images, but none of this is detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. The document does not describe any expert adjudication process.
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
- Not provided, and unlikely given the device type. The Hawkeye Option is described as an "additional hardware and software to generate corrected NM images" and "to facilitate localization." This suggests it's an image processing and display tool for a gamma camera, not an AI-assisted diagnostic tool that would typically involve human reader performance improvement metrics. The summary focuses on the technical qualities of the images (uniformity, localization) rather than diagnostic efficacy in a human-in-the-loop setting.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied, but not explicitly detailed. The "Summary of Studies" mentions "bench and clinical data show that Hawkeye attenuation-corrected images are more uniform... The images also demonstrate the localization capabilities..." This suggests that the performance observed relates to the algorithm's output (the corrected images) without necessarily involving a human's diagnostic interpretation as the primary endpoint. The qualitative statements about "uniformity" and "localization capabilities" are assessments of the algorithm's direct output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but likely based on visual assessment or phantom studies for uniformity, and image registration accuracy for localization. For "uniformity," the ground truth might be a predefined standard of image homogeneity for nuclear medicine scans or comparative visual assessment against uncorrected images. For "localization capabilities," the ground truth would likely involve the accuracy of aligning emission images with anatomical landmarks or images, potentially verified against known anatomical structures.
The sample size for the training set
- Not applicable/Not provided. The Hawkeye Option appears to be a traditional image processing and correction algorithm, not a machine learning or AI algorithm that typically requires a distinct "training set." If any parameters were learned or optimized, the training data details are not disclosed.
How the ground truth for the training set was established
- Not applicable/Not provided. As above, a specific "training set" and associated ground truth establishment methods are not mentioned, consistent with a non-AI image processing device.

Summary of Deficiencies in the Provided Information for your Request:

The 510(k) summary is extremely brief and provides very high-level declarative statements rather than detailed study methodology. It lacks specific numerical data, sample sizes, expert qualifications, clear definitions of ground truth for performance metrics, or any information typical of modern clinical performance studies, especially those involving AI. This is characteristic of older 510(k) summaries, which often focused on demonstrating substantial equivalence through more general statements and less detailed technical reporting than is now common.

Summary

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K991841

510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 9. 807.87(h))

Device Name

13.00

Proprietary Device Name : Hawkeye Option for Dual-Head Variable Angle Gamma Camera.

Establishment Name and Registration Number of Submitter

Name:
Registration Number:Corresponding Official:

ELGEMS Ltd. 9613299 Dan Laor ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL

Device Classification

Classification Code: Panel Identification: Classification Name: Common Name: Classification Class:

90 KPS Radiology ECT system (per 21CFR 892.1200 ) Nuclear Medicine Imaging system Class II Product

Reason for 510(k) Submission

Modification of legally marketed device.

Identification of Legally Marketed Equivalent Devices

VTransACT option for the VariCam Gamma Camera - K980959 Advanced Analysis Software: Fusion/Registration and rCBF Autoradiographic Model - K941223/S1

Device Description

Description of Change or Modification

The VariCam (K953801) gamma camera has been modified to accommodate for the Hawkeye transmission subsystem, by including an additional correction map for attenuation, obtained by an X-ray generation and detection system attached to the rotating frame of the gantry.

Intended Use of Device

The intended use of the device is to produce attenuation-corrected NM images. The attenuation maps are also displayed with the NM images to facilitate the localization of the NM activity in the patient anatomy.

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Summary of Studies

- Sench and clinical data show that Hawkeye attenuation-corrected images are more uniform than NM images without attenuation correction. The images also demonstrate the localization capabilities of the Hawkeye.

Conclusion

In the opinion of ELGEMS Ltd., the Hawkeye is substantially equivalent in terms of safety and effectiveness to the VTransACT (K980959) for purposes of attenuation correction, and to the Advanced Analysis Software (K941223/S1) for purposes of facilitating localization of emission activity in the patient anatomy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person's profile.

AUG 26 1999

Quality and Regulatory Affairs

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re:

K991841 Hawkeve Option for Dual-Head Variable Angle Gamma Camera Requiatory Class: Il (two) Product Code: 90 KPS 21 CFR 892.1200 Dated: May 28, 1999 Received: May 28, 1999

Dear Mr. Laor:

Mr. Dan Laor

P.O. Box 170

ISRAEL

ELGMENS, Ltd.

Tirat Hacarmel 30200

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, 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 (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,
Dan Setiz

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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K991841 510(k) Number (if known): Hawkeye option for dual head variable angle gamma Device Name: camera

Indications For Use:

To obtain attenuation corrected emission images and to provide registration of anatomical and physiological images.

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

( Concurrence of CDRH, Office of Device Evaluation (ODE) )

Javid a. hayom

ivision Sign-Off) vision of Reproductive, Abdominal, ENT, and Radiological Devices 191841 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

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.