The LumaGEM™ Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM™ Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM™ Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 keV for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.

Device Description

The LumaGEM™ Molecular Breast Imaging System is a scintillation camera system, which uses Cadmium Zinc Telluride (CZT) detectors to create an image of radionuclide distribution. The LumaGEM™ Molecular Breast Imaging System is available in a dualhead or single-head configuration and can be used to help identify suspected lesions in breast tissue as an adjunct to standard mammography. The LumaGEM™ Molecular Breast Imaging System is provided with a customized gantry, which allows flexible positioning to facilitate accurate breast imaging, and a workstation to enable image acquisition and analysis functions.

AI/ML Overview

The provided text describes the LumaGEM™ Molecular Breast Imaging System, its indications for use, and a summary of testing conducted to support substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study proving the device meets these criteria, or most of the requested information regarding study design elements such as sample sizes, expert qualifications, or ground truth establishment for either training or test sets.

The document primarily focuses on:

Administrative details: Applicant, contact person, dates, classification, product codes.
Device description: How it works (CZT detectors, dual/single head, gantry, workstation).
Indications for Use: What the device is intended for (aid in evaluation of breast lesions, adjunct to mammography, planar scintigraphy).
Predicate devices: List of substantially equivalent devices.
Testing for substantial equivalence: A general list of tests performed (Gamma camera verification, System verification, Electrical and mechanical safety, Electromagnetic compatibility) without details of methodologies, results, or acceptance criteria.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated from the text:

1. Table of acceptance criteria and the reported device performance:

Not available in the provided text. The document only lists general categories of testing performed (e.g., "Gamma camera verification testing") but does not provide specific acceptance criteria (e.g., minimum spatial resolution, sensitivity) or the corresponding performance results.

2. Sample size used for the test set and the data provenance:

Not available in the provided text. The document does not describe any clinical test sets, patient data, or their origin. The testing mentioned is bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not available in the provided text. Since no clinical test set is described, there's no mention of experts or ground truth establishment for such a set.

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

Not available in the provided text. No clinical test set details are 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 available in the provided text. The device is a "Scintillation (gamma) camera" (imaging device), not an AI-assisted diagnostic tool described with human-in-the-loop performance. The document only mentions that "resultant images are intended to be viewed by qualified medical professionals."

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

Not applicable/Not available. This is a medical imaging device, not an algorithm. The performance of the imaging system itself is implied to be evaluated by the "Gamma camera verification testing" and "System verification testing," but no specific performance metrics or "standalone" study details are provided.

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

Not available. The document does not describe any ground truth for clinical performance, as only bench testing is explicitly mentioned. For bench testing, the "ground truth" would be the known properties of the phantoms or test objects used, but these details are not provided.

8. The sample size for the training set:

Not applicable/Not available. This is an imaging device, not a machine learning algorithm that requires a training set in the typical sense.

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

Not applicable/Not available. As above, no training set for an algorithm is mentioned or implied.

In conclusion, the provided text describes the regulatory submission for an imaging device but lacks the detailed performance study information typically associated with establishing acceptance criteria against a defined clinical or algorithm performance benchmark. The "TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION" section only lists categories of bench testing rather than clinical efficacy studies.

Summary

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GAMMA MEDICA-IDEAS, INC.

SECTION 5 510(k) SUMMARY (CONT.)

510(k) Notification K 111791

GENERAL INFORMATION

Applicant:

Gamma Medica-Ideas, Inc. 19355 Business Center Drive, Suite #8 Northridge, CA, 91324 U.S.A. Phone: 818-709-2468 Fax: 818-709-2464

Contact Person:

Albert Boniske Regulatory Consultant for Gamma Medica-Ideas, Inc. 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 408-400-0856 ext. 113 Fax: 408-400-0865

Date Prepared: June 24, 2011

DEVICE INFORMATION

Classification:

21 CFR8892.1100

Product Code:

IYX

Trade Name:

LumaGEM™ Molecular Breast Imaging System

Generic/Common Name:

Scintillation (gamma) camera

PREDICATE DEVICES

Gamma Medica LumaGEM™ Scintillation Camera (K993813) . GE Healthcare Discovery NM 750b Gamma Camera (K102231) SEP 2 3 2011

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SECTION 5 510(k) SUMMARY (CONT.)

INDICATIONS FOR USE

PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the LumaGEM™ Molecular Breast Imaging System is substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the LumaGEM™ Molecular Breast Imaging System is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench testing was conducted on the LumaGEM™ Molecular Breast Imaging System to support a determination of substantial equivalence to the predicate devices. The following list includes the testing that was performed on the LumaGEM™ Molecular Breast Imaging System:

. Gamma camera verification testing
. System verification testing
. Electrical and mechanical safety testing
. Electromagnetic compatibility testing

SUMMARY

The LumaGEM™ Molecular Breast Imaging System is substantially equivalent to the predicate devices.

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Profit and and and a

Food the bring - at . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10903 New Hampshire . Fenue Document Control Rocin - WO65-G502 Silver Spring, MD 20993-0002

Gamma Medical-Ideas Incorporated % Mr. Albert Boniske Senior Manager of Regulatory Affairs Experian Group LLC – Regulatory Affairs 755 N. Mathilda Avenue, Suite 100 SUNNYVALLE CA 94085

SEP 2 3 2011

Re: K111791

KT1771
Trade/Device Name: LumaGEM™ Molecular Breast Imaging System Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: August 24, 2011 Received: August 27, 2011

Dear Mr. Boniske:

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 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 deternination 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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medical device-related adverse events) (2) CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Viiro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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/cdrlv/industry/support/index.html.

Sincerely Yours.

Mary Patel

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

Enclosure

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Indications for Use

510(k) Number (if known): K111791

Device Name: LumaGEM™ Molecular Breast Imaging System

Indications for Use:

The LumaGEM™ Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM™ Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM" Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 keV for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.

Prescription Use X (21 CFR Part 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Zuhal D. O'Hare

Division of Ra Office of In

510K. K///79/

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).