The Dilon 6800 Acella Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel.

Device Description

The Dilon 6800 Acella (Acella) is a modification to the Dilon 2000 (now known as the Dilon 6800), a high resolution, small field of view, portable gamma camera designed for general use in imaging radio pharmaceuticals. The Acella has a larger field-of-view than the Dilon 6800 and replaces photomultiplier tubes with photodiodes. Both technologies convert visible light photons generated by scintillation crystals into electronic signals.

AI/ML Overview

The provided text describes the Dilon 6800 Acella Scintillation Camera, a modification of the Dilon 6800. It focuses on the device's substantial equivalence to its predicate device and the new detector technology. However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria.

Specifically, the document lacks:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets and data provenance.
Number and qualifications of experts for ground truth.
Adjudication methods.
Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
Details on standalone algorithm performance.
Specific types of ground truth used (beyond general "performance requirements").
Sample size for the training set.
How ground truth for the training set was established.

The text primarily summarizes the technical changes and confirms that the device meets "predetermined success criteria according to established protocols" without providing the specific criteria or study details.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly detailed in a table. The document states that "Testing has demonstrated that the Acella, with the larger Field of View, has met predetermined success criteria according to established protocols." This implies criteria exist but are not presented.
Reported Device Performance: Not explicitly detailed in a table. The document states the performance is "equivalent to the Dilon 6800 camera and the predicate detector technology." No specific metrics (e.g., sensitivity, specificity, resolution, image quality scores) are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The text only mentions "Performance testing" and "Verification testing" without specifying sample sizes or data provenance.

3. 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. The text states that "The resulting images are intended to be reviewed by qualified medical personnel," but this refers to clinical use, not the ground truth establishment for testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided.

5. 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 applicable / Not provided. This device is a gamma camera (hardware), not an AI-assisted diagnostic software. There is no mention of AI or human-in-the-loop performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Applicability is limited by device type. As a hardware device (gamma camera), "standalone algorithm performance" in the context of AI is not relevant. The performance refers to the imaging capabilities of the camera itself. While tests were done as a "standalone" device (without human interpretation being part of the device's direct output), no specific metrics are given.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated. The document refers to "predetermined success criteria" and "established protocols" for performance, which likely involve phantom studies or comparison with existing validated imaging systems for physical performance metrics (like resolution, uniformity, sensitivity). It does not suggest ground truth based on pathology or clinical outcomes for diagnostic accuracy validation in the way an AI diagnostic tool might.

8. The sample size for the training set

Not applicable / Not provided. This device is a gamma camera. The concept of a "training set" is generally associated with machine learning or AI models, which is not what this device is. Its development involves engineering and hardware performance testing, not algorithmic training on data.

9. How the ground truth for the training set was established

Not applicable / Not provided. (See point 8)

Summary

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SECTION 5 510(K) Summary

MAY - - 3 2011

SUBMITTING COMPANY:

Dilon Technologies Inc Address: 12050 Jefferson Ave, Suite 340 Newport News, VA 23606 Telephone: 757-269-4910 Fax: 757-269-4912

Submitted by:

Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 Telephone: 715-549-6035 Fax: 715-549-5380 Email: Duncan@paladinmedical.com

CONTACT PERSON: DATE PREPARED (revised): TRADE NAME: COMMON NAME: CLASSIFICATION NAME: PRO CODE:

Elaine Duncan March 31, 2011 Dilon 6800 Acella Scintillation Camera camera, scintillation (gamma) IYX

SUBSTANTIALLY EQUIVALENT TO:

-SPECIAL 510(k) Modifications to Dilon 2000 (now known as Dilon 6800, K984466 for a technology change. The primary difference is the change in detector technology from photomultiplier tubes to the photodiode technology, previously cleared by FDA in K100838. Dilon Technologies, Inc. has demonstrated that there are no new safety issues due to the change in detector technology and has shown the performance of the Acella to be equivalent to the Dilon 6800 camera and the predicate detector

technology and has not altered the fundamental technology of the original Dilon 6800.

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

SUMMARY of TESTING and Design Control Compliance:

Performance testing has been provided for material change on collimator surface, software, EMC/EMI testing and other performance requirements. Verification testing was drawn from the experience with the Dilon 6800, risk analysis of software and hardware changes and conformance with international standards. Testing has demonstrated that the Acella, with the larger Field of View, has met predetermined success criteria according to established protocols and as documented through Design Control and Review. The results show the Acella is substantially equivalent to the Dilon 6800 camera and the predicate photodiode detector technology. No new safety issues are introduced as a result of the technology change.

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Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wing and body. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Dilon Technologies, Inc. % Ms. Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 STILLWATER MN 55082

MAY - 3 2511

Re: K110384

Trade/Device Name: Dilon 6800 Acella Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: II Product Code: IYX Dated: April 1, 2011 Received: April 4, 2011

Dear Ms. Duncan:

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 market 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 approval approval approval approval approval (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, unte re of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further . announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem depicts a stylized human figure with outstretched arms, symbolizing care and protection. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Dilon Technologies, Inc. % Ms. Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 STILLWATER MN 55082

MAY 1 0 2011

Re: K110384

Trade/Device Name: Dilon 6800 Acella Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: April 1, 2011 Received: April 4, 2011

Dear Ms. Duncan:

This letter corrects our substantially equivalent letter of May 3, 2011.

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 (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 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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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely Yours.

Mary S Pastel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

. -

Device Name: Dilon 6800 Acella

Indications For Use: KI10384

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary's Postel

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Page 29 of 522

Regulation Number and Section

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).