The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively if a protective sheath is used.

Device Description

The Mini Gamma Camera, MGC500, is a nuclear medical imager (commonly known as a scintillation or gamma camera) that is smaller, lighter and more portable than the existing gamma cameras. The MGC500 is intended for use in nuclear medicine procedures, including intraoperative procedures. To collect such information, it extracorporeally detects and visualizes the gamma ray emitted from an administered radiopharmaceutical. While previous gamma cameras have consisted of a sodium iodide scintillating crystal and photomultiplier tube (PMT), the design of the MGC-500 incorporates a solid-state CdTe semiconductor detector. This allows the device to be smaller, lighter, and more portable.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or most of the requested parameters related to study design (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth details, or training set information).

The text is a 510(k) summary for a Mini Gamma Camera (MGC-500) and primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with general safety and performance standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The text generally refers to meeting "specifications of the NEMA Performance Standard for scintillation cameras" and "requirements of the IEC-60601-1 for electrical safety" as the basis for performance validation. These are industry standards, not specific numerical acceptance criteria for a clinical study.
Reported Device Performance: No specific numerical performance data (e.g., sensitivity, specificity, accuracy, image quality metrics) is provided in the document. The submission states that "The performance data and descriptions in this submission will demonstrate that the MGC-500 is substantially equivalent to the predicate devices," but these data are not included in the provided summary.

Acceptance Criteria (General)	Reported Device Performance
Compliance with NEMA Performance Standard for scintillation cameras	Tested to specifications (no specific results provided in this summary)
Compliance with IEC-60601-1 for electrical safety	Tested to requirements (no specific results provided in this summary)
Substantial Equivalence to predicate devices (Digirad 2020 Notebook Imager, Neoprobe 1500/2000) for intended use and technological characteristics	Demonstrated (no specific performance data presented in this summary to support this, only statements of equivalence).

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

Sample Size: Not mentioned.
Data Provenance: Not mentioned.

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

Not mentioned.

4. Adjudication method for the test set

Not mentioned.

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 mentioned. This device is a gamma camera, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.

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

Not mentioned. The device itself is a standalone imaging system, but "standalone performance" in the context of AI usually refers to the algorithm's performance without human intervention, which is not applicable here. The device's performance would be inherent to its operation as an imaging system.

7. The type of ground truth used

Not mentioned. Given it's an imaging device, ground truth for performance studies typically involves physical phantoms, clinical studies with confirmed diagnoses (e.g., pathology, surgical findings), or comparison to a gold standard imaging modality. However, the document does not specify.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning system that requires a training set.

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

Not applicable. This device is not an AI/machine learning system that requires a training set.

Summary of available information:
The document (K040587) states that the MGC-500 was "tested to the specifications of the NEMA Performance Standard for scintillation cameras" and "the requirements of the IEC-60601-1 for electrical safety." It claims that "performance data and descriptions in this submission will demonstrate that the MGC-500 is substantially equivalent to the predicate devices." However, these specific performance data, acceptance criteria metrics, and details of any clinical or technical study beyond compliance testing are not included in the provided 510(k) Summary. The submission aims to demonstrate substantial equivalence based on technical characteristics and adherence to existing standards, rather than providing detailed clinical performance study results against specific acceptance criteria.

Summary

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K040587

510(k) Summary

Mini Gamma Camera MGC-500

Classification Name: Scintillation Camera 21 CFR 892.1100

Acrorad Company, Ltd. 13-23 Suzaki Gushikawa-shi Okinawa 904-2234 JAPAN

Phone: (+081) 98-934-8960 Fax: (+081) 98-934-8961

Contact: Mivoko Nishikawa, Prepared: March 4, 2004

LEGALLY MARKETED PREDICATE DEVICE A.

The MGC-500 is substantially equivalent to the Digirad 2020 Notebook Imager, which was cleared by FDA on May 28, 1997 as K961104. For characteristic of intraoperative use, the MGC-500 is also the substantially equivalent to the Neoprobe 1500/2000 radioisotope detector (K971320).

DEVICE DESCRIPTION B.

C. INTENDED USE

The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging The MGC-500 may also be used intraoperatively if a techniques. protective sheath is used.

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SUBSTANTIAL EQUIVALENCE SUMMARY D.

The MGC-500 is a medical device, and it has the same indications for use The MOO on a mount as the legally marketed predicate devices. The and targer population as the onomical characteristics as the predicate MGC-300 Thas the Same toonnistics of the device are sufficiently precise that performance data are not required, but for others, performance data that performance auta are no. The performance data and descriptions in is provided in this oubmison will demonstrate that the MGC-500 is substantially equivalent1 to the predicate devices.

TECHNOLOGICAL CHARACTERISTICS E.

The proposed and predicate devices both use a detector head that converts The proposed and prodicate al signals. The predicate device uses a photor chergy into bloosonvert gamma photon energy into visible light scirithlauing oct oryotar to our of the sensed by photo diodes and converted into electrical signals. The proposed Acrorad device converts gamma photons directly into electrical signals through use of a CdTe detector.

The electrical signals generated by the incoming gamma photons are The Clection of Signale generations. Discriminators are used in hardware proportional to onorg proposed and predicate devices to limit acceptable of soltware in both proposed of the radiopharmaceutical being used for imaging. The location of a gamma detection event is determined used for imaging. The channel of the detector, and standard image by the fissal algorithms are used to present the image to the user.

TESTING F.

The Mini Gamma Camera MGC-500 was tested to the specifications of the The Minn Surmance Standard for scintillation cameras. It was also tested to the requirements of the IEC-60601-1 for electrical safety.

CONCLUSIONS G.

This pre-market notification has demonstrated Substantial Equivalence as rms pro mainer stood in Sections 513(f)(1) and 513(i)(1) of the Federal delined and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in l this 510(k) is limited to the terms "oubstance in, and used by FDA in accordance with, Sections this STO(K) is limited to the trefy they they they the Federal Food, Drug, and Cosmetic Act.

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Public Health Service · ·

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2004

Acrorad Company, Ltd. % T. Whit Athey, Ph.D. Senior Consultant The Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 BROOKEVILLE MD 20833-2233

Re: K040587

Trade/Device Name: Mini Gamma Camera MGC-500 Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) Camera Regulatory Class: II Product Code: 90 IYX Dated: March 5, 2004 Received: March 5, 2004

Dear Dr. Athey:

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 either class II (Special Controls) or class III (PMA), 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 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); 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.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Mini Gamma Camera MGC-500 Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﺳﮯ (Per 21 CFR 801.109)

ાર

Over-The-Counter Use

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number.

000059

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).