assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and
assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.
assist with comparisons of activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data
NeuroQ 3.6 provides added functionality to provide analysis of amyloid uptake levels in brain regions.

Device Description

NeuroQ™ 3.6 has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can also be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric reqions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to provide analysis of amyloid uptake levels in the brain. This program was developed to run in the IDL operating system environment, which can be executed on any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

AI/ML Overview

The provided text describes the NeuroQ™ 3.6 device, its intended use, and its equivalence to previously cleared devices. However, it does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or statistical thresholds) or a detailed study description with specific results that would "prove" the device meets such criteria. Instead, it references previous validation studies and states general conclusions about safety and effectiveness.

Therefore, I cannot populate a table of acceptance criteria and reported performance, nor can I provide detailed information for many of the requested points because that specific data is not present in the provided 510(k) summary. The summary focuses on establishing substantial equivalence based on prior versions and a general statement of in-house testing.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document does not specify any quantitative acceptance criteria or reported performance metrics (e.g., specific accuracy, sensitivity, specificity values, or statistical thresholds) that the device was tested against. It states that validation for modifications can be found in "Item H. Testing & Validation," but this item itself is not included in the provided text.

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

Cannot be fully provided. The document mentions "clinical validation studies submitted in our previous 510(k) K041022 and 510(k) #: K072307" for the initial program and earlier versions. For the current version (3.6) it only refers to "in-house testing" and "final in-house validation results."
- Sample Size (Test Set): Not specified for NeuroQ™ 3.6.
- Data Provenance (country of origin, retrospective/prospective): Not specified for NeuroQ™ 3.6. The reference database is described as "brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)," but no details on its origin are given.

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)

Cannot be provided. The document does not describe how ground truth was established for any test set or mention specific experts involved in such a process for NeuroQ™ 3.6.

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

Cannot be provided. The document does not describe any adjudication method for a test set.

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, an MRMC comparative effectiveness study is not described as being performed. The document states the program "serves merely as a display and processing program to aid in the diagnostic interpretation...it was not meant to replace or eliminate the standard visual analysis." It emphasizes the physician's ultimate responsibility and integration of all information. There is no mention of a study comparing human reader performance with and without AI assistance, or any effect size.

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

Yes, implicitly, to some extent, but with a critical caveat. The device itself performs "automated analysis" and provides "quantification of relative activity." This suggests standalone algorithmic processing.
Caveat: The document explicitly states, "The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided." It also says it is "not meant to replace or eliminate the standard visual analysis" and that the physician "should integrate all of the patients' clinical and diagnostic information." This strongly indicates that while the algorithm runs automatically, its performance is not intended to be "standalone" in a diagnostic sense, as human-in-the-loop verification and interpretation are always required. No specific "standalone performance" metrics are provided.

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

Cannot be explicitly stated. The document describes a "reference database" of "asymptomatic controls (AC)" used for comparison. This implies a ground truth of "normalcy" based on the absence of identified neuropsychiatric disease or symptoms. However, the precise method of establishing this normal status (e.g., through long-term follow-up, expert clinical assessment, other diagnostic tests) is not detailed. For patient studies, the tool provides quantitative results to be integrated by a physician, but doesn't mention a specific "ground truth" used to validate its diagnostic accuracy in patient cases.

8. The sample size for the training set

Cannot be provided. The training set size for the algorithms is not mentioned. The document refers to a "reference database" of asymptomatic controls, but its size is not specified.

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

Partially described for the "reference database." The "reference database" consists of "brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)." This indicates that the ground truth for this reference is the absence of neuropsychiatric disease or symptoms. However, the specific methods (e.g., detailed clinical evaluation, exclusion criteria, follow-up) used to establish this "asymptomatic" status are not provided. The document does not explicitly discuss a separate "training set" and associated ground truth, but rather a "reference database" for comparison.

Summary

{0}------------------------------------------------

ltem l

MAY 1 7 2013

510(k) SUMMARY

Safety and Effectiveness

1. Medical Device Establishment:

Syntermed, Inc. Registration No. 1066019 Owner Operator I.D. 9041128 Device Requlation Number: 892.1200 Product Code: KPS Classification Panel: Radiology Voice: (888) 263-4446 ext 102, FAX: (714) 281-1290 Contact person: Kenneth F. Van Train Address: Syntermed, Inc. 130 Wieuca Road Suite 108 Atlanta, GA 30342 Email: vantrain@syntermed.com

Date Summary Prepared: February 20, 2013

Medical Device:

NeuroQ 3.6 - Display and Analysis program for PET Brain studies.

Classification Name - System, Tomography, Computed, Emission

Medical Device Equivalence:

NeuroQ™ 3.0, Reference #: K072307 and Siemens Medical Solutions USA, Inc. Scenium 3.0. Reference #:K123528.

4. Device Description:

{1}------------------------------------------------

differs from mean activity values of brain regions in the AC database. The program can also be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric reqions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to provide analysis of amyloid uptake levels in the brain. This program was developed to run in the IDL operating system environment, which can be executed on any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

5. Intended Use and Potential Adverse Effect on Health:

The intended use of this program was to provide the physician with a program which would allow him to co-register and display brain PET scans and compare the patients study to a reference database. The program can be used to compare the activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to provide analysis of amyloid uptake levels in the brain. This program serves merely as a display and processing program to aid in the diagnostic interpretation of a patient's study. It was not meant to replace or eliminate the standard visual analysis of the PET brain scan. The physician should integrate all of the patients' clinical and diagnostic information, i.e. patients' history, quality control images, visual interpretation of the PET brain scan, and quantitative results, prior to making his final interpretation. This comprehensive processing technique (as with all diagnostic imaging) is not perfect, and will be associated with some false positive and false negative results. The previous validation of the program can be found in the 510(k) submission for NeuroQ™ - PET DP, Ref. 510(k) #: K041022 and NeuroQ™ 3.0 (510(k) #: K072307. The validation for modifications in version 3.6 can be found in Item H. Testing & Validation of this 510(k) and the physician should be aware of the accuracy when integrating the quantitative results for his final interpretation. Therefore, this program has no direct adverse effect on health since the results represent only a part of the information, which the physician will utilize for his final interpretation. The final responsibility for interpretation of the study lies with the physician.

6. Marketing History:

There have been other medical device programs marketed in the past which perform similar functions to those performed by the NeuroQ™ 3.6 program. Most Nuclear Medicine manufacturers have programs that can co-register SPECT/PET data and some of them have programs for comparison of the patient's data to a reference database. NeuroQ™ 3.6 provides a program which executes in the IDL operating system environment and we believe is substantially equivalent to our previous version of NeuroQ™ - PET DP K041022 and NeuroQ™ 3.0 (510(k) #: K072307 and Siemens Medical Solutions USA, Inc. Scenium 3.0, Reference #:K123528. To our knowledge there have been no safety problems with NeuroQ™ - PET DP K041022 which has been in the marketplace since June 2004, NeuroQ™ 3.0 510(k) #: K072307 which has been in the marketplace since March 14, 2008, or Siemens

{2}------------------------------------------------

Medical Solutions USA, Inc. Scenium 3.0, Reference #:K123528 which has been in the marketplace since December 20, 2012.

7. Conclusions:

The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and validation. The effectiveness of the initial program, NeuroQ™ - PET DP and NeuroQ™ 3.0, has been established in in-house testing and clinical validation studies submitted in our previous 510(k) K041022 and 510(k) #: K072307. Specific details and results concerning the validation of the NeuroQ™ 3.6 program are listed in Item H. Testing & Validation. We contend that the method employed for the development and the final in-house validation results of this medical display software program, NeuroQ™ 3.6, have proven its safety and effectiveness. In our opinion, NeuroQ™ 3.6 program is substantially equivalent to our previous version of NeuroQ™ - PET DP and NeuroQ™ 3.0 program and Siemens Medical Solutions USA, Inc. Scenium 3.0 which have been cleared for marketing. NeuroQ™ 3.6 program is intended for the same purpose and raises no new issues of safety or effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, which is a symbol of medicine. The symbol is made up of three wavy lines that are connected at the top and bottom.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002

May 17, 2013

Syntermed, Inc. % Mr. Kenneth F. Van Train President 245 Owens Drive ANAHEIM CA 92808

Re: K130451

Trade/Device Name: NeuroQ™ 3.6 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography Regulatory Class: Class II Product Code: KPS Dated: February 20, 2013 Received: February 22, 2013

Dear Mr. Van Train:

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

{4}------------------------------------------------

Page 2 - Mr. Kenneth F. Van Train

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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/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/cdrh/industry/support/index.html.

Sincerely yours.

Michael D. O'Hara for

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K130451

Device Name: NeuroQTM 3.6

Indications for Use:

1. assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and
1. assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.
1. assist with comparisons of activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data
1. NeuroQ 3.6 provides added functionality to provide analysis of amyloid uptake levels in brain regions.

The product is intended for use by trained nuclear technicians and nuclear medicine physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and PET data.

Prescription Use X (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 In Vitro Diagnostics and Radiological Health (OIR)

Michael D. Huse

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130451

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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 II.