This software is intended to be used for the visualization of non-reversible perfusion defects (hypo/hyper dense areas) in patients with angina or with a previous myocardial infarct. Included software tools may aid a trained user in monitoring the disease state and treatment over time. This software provides maps and the values used to generate the maps. The information provided is intended to be qualitative in nature and when used by a qualified physician may aid in the identification of myocardial enhancement defects and the follow up of such findings.

Device Description

This device processes ECG-gated contrast enhanced cardiac scan data using MPR generated images according to the cardiac axis. The software generates polar maps, perfusion index (PI) map and Transmural Perfusion Ration (TPR) maps based upon the measured CT values of the tissue within the specified region of interest. The software displays the values associated with the generation of the Perfusion Index and TPR Maps. Pl is the ratio of the Mean Myocardial CT value to the LV blood pool CT value. TPR is provided as a ratio per sector of the Endocardial CT value to the mean Epicardial CT value.

AI/ML Overview

The provided 510(k) summary for MyoPerfusion, CSMP-001A, is a short document outlining the device's purpose and its substantial equivalence to predicate devices. While it mentions "performance testing," it does not provide detailed acceptance criteria or results from a specific clinical study that proves the device meets those criteria.

The information primarily focuses on regulatory compliance, device description, and comparison to predicate devices, rather than a detailed performance study report.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) for the device's performance in identifying perfusion defects. Similarly, it does not provide a table of reported device performance metrics against such criteria. The "Testing" section broadly states that "performance testing conducted through bench testing" demonstrates that "design specifications established for the device have been met and that the perfusion map calculation and auto segmentation used by the software will appropriately display visualization tools." This is a general statement of compliance, not a detailed performance report.

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 for Test Set: Not specified.
Data Provenance: Not specified. The document mentions "bench testing" but does not detail the nature or origin of any data used.

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)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not specified. Since details on the test set itself are absent, the adjudication method is also 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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The filing describes the device as providing "visualization tools" and "maps and values" to aid a "trained user" and "qualified physician," suggesting it's intended as an aid to diagnosis, but there is no study assessing its impact on human reader performance.
Effect Size of Improvement: Not applicable, as no MRMC study is reported.

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

Standalone Performance Study: Not explicitly indicated or detailed. The document states that the software "appropriately display[s] visualization tools," and that it "provides maps and the values used to generate the maps." This implies the algorithm's functional performance in generating these outputs was assessed, but not an independent diagnostic performance of the algorithm itself without human interpretation. The "Indications for Use" continuously emphasizes use by a "trained user" and "qualified physician," and states the information is "qualitative in nature," which further suggests it's not a standalone diagnostic tool.

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

Type of Ground Truth: Not specified.

8. The sample size for the training set

Sample Size for Training Set: Not specified. The device description notes it "processes ECG-gated contrast enhanced cardiac scan data," but doesn't mention a training set in the context of machine learning or AI. Given the date of the 510(k) (2013), and the nature of the description ("perfusion map calculation and auto segmentation"), it's possible the software relies on more deterministic algorithms rather than sophisticated AI requiring large training sets in the modern sense.

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

Ground Truth Establishment for Training Set: Not specified.

Summary of Study Information:

The 510(k) summary provides minimal information regarding specific performance studies or acceptance criteria. It focuses on demonstrating substantial equivalence to predicate devices based on intended use and similarity in the manner of performance (i.e., post-processing software for visualizing cardiovascular anatomy and pathology). The "Testing" section vaguely mentions "hazard analysis, verification/validation and performance testing conducted through bench testing" to ensure "design specifications have been met" and that the software "will appropriately display visualization tools." However, it does not offer the granular detail requested for acceptance criteria, sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone performance).

Summary

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K132523
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TOSHIBA AMERICA MEDICAL BYBTEMS, INC.

2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) - SUMMARY

TOSHIBA

1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
1. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
1. ESTABLISHMENT REGISTRATION: 2020563
1. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
1. DATE PREPARED: August 9, 2013
1. TRADE NAME(S): MyoPerfusion, CSMP-001A
1. COMMON NAME: System, X-ray, Computed Tomography
1. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
1. PRODUCT CODE / DESCRIPTION: 90JAK - System, Computed Tomography
1. PERFORMANCE STANDARD: None

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11. PREDICATE DEVICES:

Device Name	Vitrea® CTMyocardial Analysis	CardIQ Xpress 2.0	syngo.CT CardiacFunction
Marketed By	Vital Images, Inc.	GE Medical Systems	Siemens MedicalSolutions, Inc.
510(k) ClearanceNumber	K112531	K073138	K110366
Clearance Date	November 18, 2011	February 26, 2008	April 12, 2011

12. REASON FOR SUBMISSION:

New accessory software

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

15. SUBSTANTIAL EQUIVALENCE:

MyoPerfusion, CSMP-001A, performs in a manner similar to and is intended for the same use as the predicate devices in that all are post processing software used to visualize cardiovascular anatomy and pathology. All of these devices utilize CT angiography images/data in order to display various diagnostically useful functions such as the display of polar maps based upon the CT values of the myocardium. In addition, MyoPerfusion provides numerical values used to calculate comparison ratios including Perfusion Index and Transmural Perfusion Ratio. The implementation of these additional features does not result in additional indications of use but rather a variation in the method of displaying the polar maps.

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16. SAFETY:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR $1020. that apply to this device, will be met and reported via product report.

17. TESTING

Hazard analysis, verification/validation and performance testing conducted through bench testing are included in this submission which demonstrates that the design specifications established for the device have been met and that the perfusion map calculation and auto segmentation used by the software will appropriately display visualization tools used by physicians to analyze myocardial perfusion.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

18. CONCLUSION

MyoPerfusion, CSMP-001A, performs in a manner similar to and is intended for the same use as the predicate devices. Based upon the data presented in this submission including application of design controls and performance data, Toshiba America Medical Systems, believes that MyoPerfusion, CSMP-001A, is substantially equivalent in safety and effectiveness to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 12, 2013

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 244 I Michelle Drive TUSTIN CA 92780

Re: K132523

· Trade/Device Name: MyoPerfusion, CSMP-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 12, 2013 Received: September 13, 2013

Dear Mr. Biggins:

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 10 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 (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Biggins

1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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.fdagov/McdicalDevices/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/ResourcesforYou/Industry/default.hum.

Sincerely yours,

for

Janine M. Могтіs 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):

K132523

Device Name:

MyoPerfusion, CSMP-001A

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)

Sm. 7)

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

510(k)________________________________________________________________________________________________________________________________________________________________________ K132523

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Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.