The CoDe AC attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected Positron Emission Tomography images for non-uniform attenuation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CoDe AC: Attenuation Correction System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage improvement, a threshold for artifact reduction). However, the overarching acceptance criterion is demonstrating substantial equivalence to the predicate device, VTransACT option for the Apex VariCam (K980659), in terms of safety and effectiveness.

Acceptance Criteria Category	Specific Metric (Implied)	Acceptance Threshold (Implied)	Reported Device Performance
Image Uniformity	Degree of uniformity in PET images after attenuation correction	No significant difference compared to predicate	Delivers more uniform images than regular coincidence imaging without attenuation correction. Comparison to VTransACT images shows no significant difference.
Safety	No new safety concerns raised	Adherence to existing safety standards for similar devices and design features	Sealed and shielded source, manually activated, no electro-mechanical shutter, self-powered LED, well-collimated, integral part of septa collimator.
Effectiveness (General)	Ability to produce attenuation-corrected PET images	Substantially equivalent to predicate	Stated as substantially equivalent to the VTransACT option.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Bench data and Clinical data" were used, but no specific number of cases or patients is given for the clinical data.
Data Provenance: Not explicitly stated. However, the manufacturer is ELGEMS Ltd., located in Tirat Hacarmel, Israel, suggesting the data may have originated from Israel. It is not specified if the data was retrospective or prospective.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

Was an MRMC study done? It is not explicitly stated that an MRMC comparative effectiveness study was performed. The phrasing "Comparison to VTransACT images shows no significant difference" suggests a comparison, but not necessarily with human readers involved or an MRMC design.
Effect size of human reader improvement: This is not applicable as an MRMC study with human readers assessing improvement with human-AI assistance is not mentioned. The device's primary function is to correct images, not to directly assist human interpretation in a comparative effectiveness study of the AI system itself.

6. Standalone (Algorithm Only) Performance

Was a standalone performance study done? Yes, implicitly. The statement "Bench data and Clinical data show that the CoDe AC option for the VariCam delivers more uniform images than regular coincidence imaging system without attenuation correction. Comparison to VTransACT images shows no significant difference" refers to the performance of the device's algorithm in generating corrected images. It is assessing the algorithm's output directly.

7. Type of Ground Truth Used

The ground truth used for image uniformity and attenuation correction is implicitly based on:

Comparison to a legally marketed predicate device (VTransACT): The "no significant difference" claim implies that the VTransACT's corrected images served as a de-facto "ground truth" or a benchmark for acceptable performance.
Improvement over uncorrected images: The statement "delivers more uniform images than regular coincidence imaging system without attenuation correction" suggests that the physical reality of non-uniform attenuation and its correction served as the ground truth against which uniformity was assessed. This would likely involve phantom studies (bench data) where the true attenuation is known or controlled.

8. Sample Size for the Training Set

This information is not provided in the document.

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

This information is not provided in the document. Given the nature of an attenuation correction system (a signal processing and image reconstruction task), the "training" might involve developing algorithms to correct known physical phenomena rather than training on a large dataset with expert-labeled ground truth in the same way an AI diagnostic system would. However, the document does not elaborate on the development or training process.

Summary

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K994167

S Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• 972-4-8563660 • FAX: 972-4-8577662

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

Device Name

CoDe AC: Attenuation Correction System for the VariCam Gamma Camera.

Establishment Name and Registration Number of Submitter

ELGEMS Ltd. Name: 9613299 Registration Number: Corresponding Official: Dan Laor ELGEMS Ltd. P.O. Box 170

Tirat Hacarmel 30200, ISRAEL

Device Classification

Classification Code: 90 IYX Panel Identification: Nuclear Medicine Classification Class: Class II Product

Reason for 510(k) Submission Modification of legally marketed device.

Identification of Legally Marketed Equivalent Devices

VTransACT option for the Apex VariCam (Millenium VG Gamma Camera) -K980659

Device Description

Description of Change or Modification

The VariCam (K953801) gamma camera has been modified to accommodate for the CoDe AC attenuation correction system, by including an additional correction map for attenuation, obtained by one line of shielded point sources inserted in the septa collimator of the camera. This map is used to create an attenuation-corrected image.

Intended Use of Device

The intended use of the device is to produce attenuation-corrected PET images, even when attenuation coefficients are not uniform over the FOV.

Summary of Studies

Bench data and Clinical data show that the CoDe AC option for the VariCam delivers more uniform images than regular coincidence imaging system without attenuation correction. Comparison to VTransACT images shows no significant difference.

Summary of the Safety

The CoDe AC sealed and shielded source is activated manually, with no need of electro-mechanical shutter. The source exposure is done only during the transmission

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ELGEM.

ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL. TEL: 972-4-8563660 • FAX: 972-4-8577662

scan in a sequential transmission acquisition. A self-powered LED indicates continuously the status of the sources. The source is well collimated to the opposite detector FOV only. The CoDe AC option is an integral part of the septa collimator and no motion of the device is needed during the scan.

Conclusion

In the opinion of ELGEMS Ltd., the CoDe AC is substantially equivalent in terms of safety and effectiveness to the VTransACT option. The CoDe AC has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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MAR - 7 2000

Lan Laor VP-Quality and Regulatory Affairs ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200 ISRAEL

Re:

K994167 CoDe AC: Attenuation Correction System for Dual-Head Variable Angle Gamma Camera with the Coincidence Option (CoDe) Dated: August 1, 1999 Received: December 9, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Laor:

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 vour device is classified (see above) into either class II (Special Controls) or 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 requlation (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 requlatory 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 vour 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) 594-4591. 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" (21CFR 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,

Daniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known): UNKNOWN K994167

Device Name: CoDe AC : Attenuation Correction System for Dual-Head Variable Angle Gamma Camera with the Coincidence Option (CoDe).

Indication For Use:

To obtain attenuation corrected Positron Emission Tomography (PET) images, by a Gamma Camera.

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

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K994167

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.