The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel. The ergo Imaging System is used by trained medical personnel to perform nuclear medicine studies.

It is indicated for lymphatic scintigraphy and parathyroid scintigraphy, It can be used intraoperatively when protected by sterile drapes. It is also indicated to aid in the evaluation of lesions in the breast and other small body parts. When used for breast imaging, it is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.

Device Description

The ergo Imaging System incorporates Digirad's Solid State RIM detector design with 3mm pixels for general purpose planar imaging, cleared under K100838. Sterile drapes are specified for intraoperative use. The ergo Imaging System, in conjunction with the optional Breast Imaging Accessory (BIA), enables the user to perform scintimammography and extremity imaging with stabilization.

AI/ML Overview

The provided text is a 510(k) summary for the Digirad ergo Imaging System, which is a gamma camera. The document primarily focuses on demonstrating substantial equivalence to a predicate device and expanding indications for use.

Based on the provided text, the device itself is a gamma camera, not an AI/ML-based device. The "Testing" section (H) explicitly states: "Verification and Validation tests were conducted to demonstrate the ergo Imaging System functions per specification. These tests include Electromagnetic Compatibility, Electrical Safety, and gamma camera performance testing including NEMA standard NU 1-2007 with phantoms."

This indicates that the acceptance criteria and performance evaluation are related to the physical performance of the gamma camera, not to algorithmic performance on image interpretation. Therefore, the requested information elements related to AI/ML device testing (such as ground truth establishment with experts, MRMC studies, standalone algorithm performance, training/test set sample sizes for algorithms, etc.) are not applicable to this submission as described.

The acceptance criteria are likely standard NEMA performance metrics for gamma cameras. While the document broadly states "Testing results demonstrate that the ergo Imaging System continues to meet the specifications," it does not list specific numerical acceptance criteria or performance metrics in a table format within this 510(k) summary.

Therefore, many of the requested items cannot be extracted from this specific document.

Here's an attempt to answer the quantifiable parts based on the provided text, while noting the limitations:

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

Acceptance Criteria: Not explicitly listed as numerical targets in the summary. Implied to be compliance with NEMA NU 1-2007 standards for gamma camera performance.
Reported Device Performance: Not explicitly listed as numerical results in the summary. The summary states: "Testing results demonstrate that the ergo Imaging System continues to meet the specifications and is substantially equivalent to the predicate devices, based on comparisons of intended use and technology, and overall system performance."

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

Sample Size: Not applicable in the context of an AI/ML test set. The testing described involves physical phantoms and engineering tests, not patient data sets.
Data Provenance: Not applicable.

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 applicable. Ground truth was established by physical phantoms and engineering measurements according to NEMA standards for gamma camera performance.

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

Not applicable.

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

No. This is not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML diagnostic algorithm.

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

Physical phantoms and engineering specifications/measurements (NEMA standard NU 1-2007).

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set mentioned.

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

Not applicable.

In summary, the provided document describes a traditional medical device (gamma camera) and its regulatory submission, which relies on engineering performance standards (like NEMA) rather than clinical studies involving AI/ML performance on patient data sets with human experts.

Summary

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JAN 1 5 2013

6 510(K) SUMMARY

A. Sponsor

Digirad® Corporation 13950 Stowe Drive Poway, California 92064 Contact Person: Matthew Olow Director, Quality and Regulatory Affairs Tel: (858) 726-1309 Fax: (858) 726-1467

. . . . . .

B. Date Prepared: November 1, 2012

C. Device Name

Trade Name:	ergo™ Imaging System
Common Name:	Camera, Scintillation (Gamma)
Classification Name:	Scintillation (gamma) camera
Device Class:	21CFR 892.1100, Class I
Product Code:	IYX

Cleared/Predicate Devices D.

The ergo Imaging System is substantially equivalent to the following cleared devices:

. ergo Imaging System, K100838 Cleared on April 23, 2010 Product Code: IYX CFR Section: 892.1100 Device Class: Class I Classification Panel: Radiology
- LumaGEM Molecular Breast Imaging System, K111791 ● Cleared on September 23, 2011 Product Code: IYX CFR Section: 892.1100 Device Class: Class I Classification Panel: Radiology

ட். Device Description

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Digirad Corporation

Breast Imaging Accessory (BIA), enables the user to perform scintimammography and extremity imaging with stabilization.

F. Intended Use & Indications for Use

G. Technology

The ergo Imaging System utilizes Digirad's solid state detector technology comprised of arrays of thatlium-doped cesium iodide crystal scintillators coupled to silicon photo diodes. Standard and optional collimators are available for different types of imaging.

H. Testing

Verification and Validation tests were conducted to demonstrate the ergo Imaging System functions per specification. These tests include Electromagnetic Compatibility. Electrical Safety, and gamma camera performance testing including NEMA standard NU 1-2007 with phantoms.

l. Conclusion

The ergo Imaging System that is the subject of this submission, is the same device that was cleared under K100838. Testing results demonstrate that the ergo Imaging System continues to meet the specifications and is substantially equivalent to the predicate devices, based on comparisons of intended use and technology, and overall system performance.

New indications are well-supported in the scientific literature, are routine applications of general-purpose gamma cameras, and have been demonstrated to be within the clinical capability of the ergo Imaging System. Therefore the new indications raise no new questions of safety or efficacy.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with three wavy lines extending from its body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Mr. Matthew Olow Director, Quality and Regulatory Affairs DIGIRAD Corporation 13950 Stowe Drive POWAY CA 92064-8803

January 15, 2013

Re: K123408

Trade/Device Name: ergo Imaging System Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: November 1, 2012 Received: November 5, 2012

Dear Mr. Olow:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2-Mr. Olow

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,

Michael D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123408

Device Name: ergo Imaging System

Indications for Use:

Prescription Use X (Part 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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Arshad D. Khan

Division Sign Of Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K/23408

Page 1 of 1

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).