The MIE - Gamma Camera Systems for nuclear medicine, are used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients

Device Description

All MiE remanufactured Gamma Camera System have 3 functional units equivalent to the Siemens or GE Gamma Camera Systems. The modification to the SIEMENS- or GE-Gamma Camera System consisted of removal of certain low voltage cicuit boards in the gamma Camera and the gantry portions of the Siemens – or GE Gamma Camera System and installing proprietary low voltage circuit board that allow the use of our SCINTRON Computer and its software. All MIE Gamma Camera Systems consist of the same detector unit that is in use in the Siemens- or GE Gamma Camera System. The mechanical units (camera head with its supporting beam) hold the detector and make sure it can be moved around or along the patient for the optimal diagnostic procedure. The only difference to the basic SIEMENS or GE Gamma Camera system consists in our own imaging and processing software SCINTRON (already cleared by the FDA, K953193).

AI/ML Overview

This document describes a 510(k) premarket notification for MIE Gamma Camera Systems. The core of the submission is to demonstrate substantial equivalence to predicate devices (Siemens and GE Gamma Camera Systems), rather than proving the device meets specific acceptance criteria through a standalone study with a defined ground truth and expert review.

Therefore, providing the exact requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, etc.) is not directly applicable in the way it would be for a novel AI/CAD device.

However, I can extract and infer information relevant to the spirit of your request:

1. A table of "Acceptance Criteria" and the Reported Device Performance (Inferred from Substantial Equivalence Claim)

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance
Indications for Use: Same as predicate devices	"The MIE remanufactured Gamma Camera Systems have the same indications for use and target population as the predicate devices." (Page 2)
Target Population: Same as predicate devices	"The MIE remanufactured Gamma Camera Systems have the same indications for use and target population as the predicate devices." (Page 2)
Diagnostic Effect: No differences from predicate devices	"There are no differences regarding the diagnostic effect." (Page 2)
Technological Characteristics: Same as predicate devices	"The MIE remanufactured devices have the same technological characteristics as the basic SIEMENS or GE Devices." (Page 2)
Technical Data/Specifications: Achieve same as predicate devices	"The technical data's and specifications in Annex 1 show that the MIE remanufactured Gamma Camera System achieve the same technical data's as the basic SIEMENS or GE Gamma Camera systems." (Page 2)
Electrical Safety: Compliance demonstrated	"Performance testing addressed the following issues: Electrical safety." (Page 3)
Electromagnetic Compatibility (EMC): Compliance demonstrated	"Performance testing addressed the following issues: Electromagnetic compatibility." (Page 3)
NEMA Performance Standards: Compliance demonstrated	"Performance testing addressed the following issues: NEMA Performance standards." (Page 3)

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

Sample Size: Not applicable in the context of this 510(k). The submission relies on demonstrating that the remanufactured device, by using the same detector and mechanical units as the predicate devices and replacing only specific low-voltage circuit boards and implementing their own software (SCINTRON, already cleared), maintains the predicate's performance. There isn't a "test set" of patient data used in the typical sense for evaluating a diagnostic algorithm.
Data Provenance: Not specified, as it's not a study involving patient data collection for performance evaluation. The "data" refers to technical specifications and compliance with standards.

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

Not applicable. This submission is not based on expert-derived ground truth from a diagnostic imaging dataset. The "ground truth" here is the established performance and safety of the predicate devices.

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

Not applicable. No diagnostic test set requiring adjudication was used.

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 MRMC study was conducted. This device is a remanufactured gamma camera system, not an AI or CAD software intended to assist human readers.

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

Not applicable. The device is a gamma camera system, not a standalone algorithm. Its software (SCINTRON) was previously cleared (K953193), suggesting its standalone function was assessed at that time, but the details are not part of this submission. This submission focuses on the system with the remanufactured components.

7. The type of ground truth used:

The "ground truth" in this context is the established performance, safety, and technological characteristics of the legally marketed predicate devices (Siemens and GE Gamma Camera Systems). The MIE Gamma Camera System is claiming to perform equivalently by maintaining the core components and adhering to relevant standards.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for an algorithm.

Summary

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KD53086

JAN 2 7 2006

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Submitted by:

Telephone:

Fax:

MIE America Inc. 420 Benett Road

Elk Grove Village, IL 60007

847 981 6100

847 981 3232

Contact Person:

Date Summary prepared

06/24/2005

Kay Warren

Trade Name of Devices

Gamma Camera Systems

Common Name Classification

Class I

MIE - BODYSCAN SCINTRON MIE - SD-X 37 SCINTRON MIE - LFOV SCINTRON

MIE - Gamma Camera Systems

Class II

MIE ORBITER SCINTRON MIE - DIACAM SCINTRON MIE - MULTISPECT 2 SCINTRON MIE - MULTISPECT 3 SCINTRON MIE - GE-XR/T SCINTRON MIE - GE-AC/T) SCINTRON
Summary 30-06-2005 doc

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Image /page/1/Picture/1 description: The image shows a logo with the letters 'MiE' in a bold, sans-serif font. The letters are white and set against a black rectangular background. The 'i' in 'MiE' has a circular dot above it. The logo appears to be a stylized representation of the company or brand name.

Substantial Equivalence:	MIE Gamma CameraSystem	Substantial equivalentsystem
	MIE - ORBITER-SCINTRON	SIEMENS ORBITER II CCI / Spect
	MIE - DIACAM- SCINTRON	SIEMENS DIACAM GAMMA CAMERA
	MIE - MULTISPECT 2 - SCINTRON	SIEMENS MULTISPECT ™ 2 DUALDETECTOR CAMERA SYSTEM
	MIE - MULTISPECT 3 - SCINTRON	SIEMENS MULTISPECT ™ 3 TRIPLEDETECTOR CAMERA SYSTEM
	MIE - BODYSCAN- SCINTRON	SIEMENS BODYSCAN
	MIE - LFOV - SCINTRON	BASICAM Counter balanced
	MIE - 9SD-X 37 - SCINTRON	BASICAM Counter balanced
	MIE - GE-XR/T - SCINTRON	GE Starcam 4000
	MIE - GE-AC/T - SCINTRON	GE Maxicamera 400 ac
	The MIE - Gamma Camera Systems for nuclear medicine,used to perform static, dynamic and gated studios, as well as

rm static, dynamic and gated studies, as well as Intended Use: spect or planar procedure, on standing, seated or recumbent patients

A Description of the device:

All MiE remanufactured Gamma Camera System have 3 functional units equivalent to the Siemens or GE Gamma Camera Systems.

Image /page/1/Figure/6 description: The image shows a block diagram of a system with three main components. The components are labeled as "Mechanical unit (SIEMENS or GE)", "Detector SIEMENS ZLC Digitrac or GE Autotune", and "MIE SCINTRON WORKSTATION". Arrows indicate that the mechanical unit and detector are connected to the MIE SCINTRON workstation.

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Image /page/2/Picture/1 description: The image shows a logo with the letters 'MiE' in white against a black background. The letters are stylized and bold. The logo appears to be cropped on the right side.

The modification to the SIEMENS- or GE-Gamma Camera System consisted of removal of certain low voltage cicuit boards in the gamma Camera and the gantry portions of the Siemens – or GE Gamma Camera System and installing proprietary low voltage circuit board that allow the use of our SCINTRON Computer and its software.

Detecting units

All MIE Gamma Camera Systems consist of the same detector unit that is in use in the Siemens- or GE Gamma Camera System, and we claim substantial equivalence in comparison to that detector unit.

Mechanical units

The mechanical units (camera head with its supporting beam) hold the detector and make sure it can be moved around or along the patient for the optimal diagnostic procedure.

For more details see the descriptions of the devices in Annex 2.

There are no differences between the mechanical units from the SIEMENS or GE Gamma Cameras and the MIE remanufactured Gamma Cameras.

SCINTRON Workstation

The only difference to the basic SIEMENS or GE Gamma Camera system consists in our own imaging and processing software SCINTRON (already cleared by the FDA, K953193).

The technical data's and specifications in Annex 1 show that the MIE remanufactured Gamma Camera System achieve the same technical data's as the basic SIEMENS or GE Gamma Camera systems.

B Substantial Equivalence Summary

The MIE remanufactured Gamma Camera Systems have the same indications for use and target population as the predicate devices. There are no differences regarding the diagnostic effect. The MIE remanufactured devices have the same technological characterstics as the basic SIEMENS or GE Devices. For all technical data performance data are provided to assure equivalence.

C Technical Characteristics

The technological characteristics are the same as those of the predicate devices.

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Image /page/3/Picture/1 description: The image shows a logo with the letters "MiE" in a bold, sans-serif font. The letters are white and are set against a black rectangular background. The letters are slightly slanted to the right, giving the logo a dynamic appearance. The logo is simple and modern, with a focus on readability and visual impact.

D Testing

Performance testing addressed the following issues:

Electrical safety .
. Electromagnetic compatibility and
NEMA Performance standards .

E Conclusions

This pre-market notification has demonstrated Substantial Equivalence between the MIE remanufactured Gamma Camera Systems and the basic SIEMENS or GE Gamma Camera System as defined and understood in Sections 513 (f) (1) and 513 (i) (1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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510 (k) number:

Device Name: MIE Gamma Camera System

Indication for Use: The MIE Gamma Camera Systems for nuclear medicine, used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients

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Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Public Health Service

JAN 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kay Warren Official Correspondent MIE America, Inc. 420 Benett Road ELK GROVE VILLAGE IL 60007 Re: K053086

Trade/Device Name: MiE-Gamma Camera Systems Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: I and II Product Code: KPS and IYX Dated: March 17, 2005 Received: November 15, 2005

Dear Ms. Warren:

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 (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 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 docs 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 clectronic 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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C. Brigdon

Nancv 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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Indications for Use

长053086

510(k) Number (if known):

Device Name:

Indications For Use:

MiE - Gamma Camera Systems MiE - Gamma Camera Systems

The MIE - Gamma Camera Systems for nuclear medicine, are used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients

Prescription Use (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 Device Evaluation (ODE)

Daniel Ch. Nguyen
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Page I of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A