The Dual Energy System allows the system to acquire two CT images of the same anatomical location using distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the dose of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in x-ray attenuation between these distinct energies.

This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials.

The visualization of the differentiation between uric acid and non-uric acid stones greater than 3mm and the visualization of uric acid presence within surrounding anatomical structures is provided with the Dual Energy system. When used by a qualified physician, a potential application is to determine the course of treatment.

Performance of this device may be affected by body size and motion artifacts.

Device Description

Dual Energy System Package, CSDP-001A, consists of three software packages intended to be used on Toshiba CT systems which allows for the acquisition of two CT images of the same anatomical location using different tube voltages and/or tube currents during two tube rotations.

CSDP-001A/1 (Dual Energy System) allows the same region to be scanned at two different tube voltages and tube currents and permits the CT values and ratio in the selected region to be measured based on the two image data sets obtained, providing information that is useful for identifying materials.

CSDP-001A/2 (Dual Energy Raw Data Analysis) allows monochromatic images to be generated and permits images in which contrast enhancement is visualized to be generated based on the datasets acquired by scanning the same positions with different tube voltages, making it possible to perform analysis.

CSDP-001A/3 (Dual Energy Composition Analysis) reads data acquired by scanning the same positions with different tube voltages and extracts suspected uric acids from the acquired images.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the Toshiba Dual Energy System Package, CSDP-001A, meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Claim	Acceptance Criteria (Implicit)	Reported Device Performance
Uric Acid Analysis (Visualization in Surrounding Structures)	Software can provide visualization of uric acid within surrounding structures.	Demonstrated through studies using:
		- A water phantom with known regions of uric acid adjacent to calcium inserts.
		- A custom anthropomorphic hand phantom containing varying concentrations of monosodium urate.
		- One clinical case: A patient with suspected gout in the right hand. Scanned with low and high tube voltage. Resultant images displayed highlighted regions of suspected uric acid, one of which was surgically extracted and confirmed by polarized microscopy.
Monochromatic Imaging (Beam Hardening Reduction)	Reduction in beam hardening artifacts compared to single energy scans is possible.	A custom phantom simulating a beam hardening artifact situation was used. Demonstrated a reduction in beam hardening artifacts compared to a single energy scan.
Monochromatic Imaging (Contrast-Noise Ratio Improvement)	Monochromatic images have improved Contrast-Noise Ratio (CNR) compared to single energy scans.	A custom phantom with tubes of varying water/iodine concentrations was scanned. Monochromatic images were generated, and it was demonstrated that these images had improved CNR compared to single energy scans.
Kidney Stone Analysis (Differentiation in Tissue)	Software is able to differentiate between uric acid and nonuric acid kidney stones within a representative abdominal phantom.	Kidney stones of known material inserted into a representative abdominal phantom. Results demonstrated the software's ability to differentiate.
Kidney Stone Analysis (Mixed Stones Discrimination)	Pure uric acid stones within a mixture can be discriminated from other stones.	Vials with pure and mixed kidney stones inserted into a phantom. Analysis concluded that pure uric acid stones could be discriminated from other stones within the mixture.
Kidney Stone Analysis (Body Size Influence)	Pure uric acid stones can be discriminated from other stones across various body sizes.	Vials with kidney stones of known composition inserted into a phantom designed to imitate various human body sizes. Analysis concluded that pure uric acid stones could be discriminated from the other stones.
Kidney Stone Analysis (Clinical Performance - Pure Uric Acid >3mm)	Detect pure uric acid stones greater than 3mm with a specified sensitivity and specificity.	Clinical Study (12 patients):
	Sensitivity: >75%	Sensitivity: 75%
	Specificity: >83.3%	Specificity: 83.3%
Motion Artifacts	Ratio of motion artifacts significantly affecting images is nearly non-existent.	Evaluated using CT image data from cases with and without breathing. Data scored for motion artifacts. Concluded that the ratio of motion artifacts that could have a significant effect on images was nearly non-existent.
Iodine Map	No significant difference between iodine map values and actual iodine concentrations. Visualization of ischemic regions is possible.	Water phantom with tubes of diluted contrast medium scanned. Concluded no significant difference between iodine map values and actual iodine concentrations. Clinical Study (1 patient): Representative clinical data set of a patient with suspected small bowel ischemia. Iodine map output. Analysis demonstrated visualization of the ischemic region due to lack of contrast enhancement.

2. Sample Sizes and Data Provenance

Test Set Sample Sizes:
- Kidney Stone Analysis (Clinical): 12 patients.
- Uric Acid Analysis (Clinical): 1 patient.
- Iodine Map (Clinical): 1 patient.
- Phantom Studies: Not specified in terms of "sample size," but involved custom phantoms and vials with known materials.
- Motion Study: "CT image data obtained from cases with and without breathing," but the number of cases is not specified.
Data Provenance: Not explicitly stated, but the submission is from Toshiba America Medical Systems, Inc., suggesting the studies were conducted or overseen by them. The text does not specify the country of origin for clinical cases. The studies appear to be prospective for the clinical data collected for the purpose of this submission, and likely internal for the phantom studies.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The text mentions "qualified physician" in the Indications for Use, implying medical supervision, but doesn't detail the qualifications of those interpreting the images or establishing ground truth for the studies.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the interpretation of test set images. For the clinical kidney stone analysis, it states "Stone analysis of the resultant images was performed," without specifying who performed it or if there was a consensus process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is reported in this summary. The studies focus on the standalone performance of the device or a very limited number of clinical cases. There is no mention of comparing human readers with and without AI assistance or any effect sizes for such comparisons.

6. Standalone (Algorithm Only) Performance

Yes, the non-clinical (phantom) testing and the methodology described for the clinical studies largely represent standalone performance of the algorithm. The device's ability to differentiate materials, reduce artifacts, improve CNR, and quantitatively measure features (like uric acid differentiation and iodine concentration) is assessed directly through image analysis and comparison to known ground truth (phantoms, pathology). The clinical studies evaluate the direct output of the system and compare it to confirmed ground truth.

7. Type of Ground Truth Used

Pathology:
- Uric Acid Analysis (Clinical): Surgically extracted tissue confirmed by polarized microscopy analysis.
- Kidney Stone Analysis (Clinical): Stone compositions confirmed using polarized microscopy.
Known Composition in Phantoms:
- Water phantom with known regions of uric acid, calcium inserts, and monosodium urate.
- Custom phantom designed for beam hardening simulation.
- Custom phantom containing tubes filled with varying concentrations of water/iodine.
- Representative abdominal phantom with kidney stones of known material.
- Vials with pure and mixed kidney stones.
- Phantom designed to imitate various human body sizes with known composition kidney stones.
- Water phantom with tubes filled with diluted contrast medium of varying concentrations.
Clinical Observation/Outcome Inferential Ground Truth:
- Iodine Map (Clinical): "Visualization of the ischemic region is possible due to the lack of contrast enhancement in the lower perfusion region." This implies clinical diagnosis or a strong clinical indicator of ischemia was the ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size of a training set. This summary is focused on verification and validation testing, not the development or training process of the software.

9. How Ground Truth for the Training Set Was Established

Since no information about a training set is provided, there is also no information on how ground truth for any training data was established.

Summary

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K132813
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FEB - 6 2014

ТОБНІВА АМЕЙІСА МЕСІСАЦ БУВТЕМБ, І№С. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

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

5. DATE PREPARED:

January 9, 2014

6. TRADE NAME(S):

Dual Energy System Package, CSDP-001A

7. COMMON NAME:

System, X-ray, Computed Tomography

8. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)

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9. PRODUCT CODE / DESCRIPTION:

90JAK - System, Computed Tomography

10. PERFORMANCE STANDARD:

None .

11. PREDICATE DEVICES:

Product	Marketed by	510(k) Number	Clearance Date
Discovery CT 750HD	GE Healthcare	K120833	June 12, 2012
Brilliance Dual EnergyOption	Philips Medical Systems,Inc.	K090462	June 23, 2009
syngo Dual Energy withextended functionality	Siemens Medical SolutionsUSA, Inc.	K083524	April 1, 2009

12. DEVICE DESCRIPTION:

CSDP-001A/3 (Dual Energy Composition Analysis) reads data acquired by scanning the same positions with different tube voltages and extracts suspected uric acids from the acquired images.

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13. INDICATIONS FOR USE:

Performance of this device may be affected by body size and motion artifacts.

14. SUBSTANTIAL EQUIVALENCE:

The Dual Energy System Package, CSDP-001A is substantially equivalent to the Discovery CT750HD, the Brilliance Dual Energy Option and the syngo Dual Energy with extended functionality.

Dual Energy System Package, CSDP-001A, performs in a manner similar to the predicate devices in that these systems allow for the acquisition of two CT images of the same anatomical location using different tube voltages and/or currents and when the images are combined they can be used for the visualization and further analysis of anatomical and pathological structures. The subject device accomplishes image acquisition using two rotations with one tube, rather than in one tube rotation as utilized by the predicate devices. The method of kidney stone characterization also differs from that used by Discovery CT750HD in that an image based two material decomposition method is used in the subject device, whereas, the predicate device uses a spectrum of effective atomic number.

15. SAFETY:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.

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16. NON-CLINICAL TESTING

Verification and validation testing, hazard analysis and performance testing conducted through bench and clinical testing are included in this submission to support the claims and indications.

Uric Acid Analysis

Studies using a water phantom with known regions of uric acid adjacent to calcium inserts and a custom anthropomorphic hand phantom containing varying concentrations of monosodium urate were conducted to confirm that the software can provide visualization of uric acid within surrounding structures.

Monochromatic Imaging

Beam Hardening Reduction

A custom phantom designed to simulate a beam hardening artifact situation was utilized to confirm that a reduction in beam hardening artifacts was possible using the Dual Energy System Package as compared to a single energy scan.

Contrast-Noise Ratio (CNR) Improvement

A custom phantom containing tubes filled with varying concentrations of water/iodine was scanned using the Dual Energy System Package to generate monochromatic images. The software selected images with ideal contrast to noise ratio and it was demonstrated that, in comparison single energy scans, the monochromatic images had improved contrast-noise ratio.

Kidney Stone Analysis

Kidnev Stones in Tissue

Kidney stones of known material were inserted into a representative abdominal phantom and scanned with the Dual Energy System Package. Results of the study demonstrated that the software is able to differentiate between uric acid and nonuric acid kidney stones within a representative abdominal phantom.

Mixed Stones

Vials consisting of pure and mixed kidney stones were inserted into a phantom and scanned using the Dual Energy System Package. Analysis of the results concluded that the pure uric acid stones within the mixture could be discriminated from the other stones.

Body Size

Vials consisting of kidney stones of known composition were inserted into a phantom designed to imitate various human body sizes. The phantom was scanned using the software and analysis of the results concluded that the pure uric acid stones could be discriminated from the other stones.

Motion

Frequency of patient motion artifacts was evaluated using CT image data obtained from cases with and without breathing. The data was scored on level of motion artifacts and the results of the study concluded that the ratio of motion artifacts that could have a significant effect on the images was nearly non-existent.

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K132813
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lodine Map

A water phantom containing tubes filled with diluted contrast medium of varying concentrations was scanned using Dual Energy volume scan. lodine maps were generated by the software and it was concluded that there was no significant difference between the iodine map values and the actual iodine concentrations.

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

17. CLINICAL TESTING

Uric Acid Analysis

A patient with suspicion of gout in the right hand was scanned twice using low and high tube voltage. The volumes were loaded to the Dual Energy analysis software and the resultant images displayed high-lighted regions of suspected uric acid. One of the suspected regions was surgically extracted and confirmed to be uric acid by polarized microscopy analysis.

Kidney Stone Analysis

A total of twelve (12) patients were scanned using a Toshiba CT system with the Dual Energy System Package. Stone analysis of the resultant images was performed and it was determined that the system was able to detect pure uric acid stones greater than 3 mm with a 75% sensitivity and an 83.3% specificity. Stone compositions were confirmed using polarized microscopy.

lodine Map

One representative clinical data set of a patient with suspicion of ischemia in the small bowel was acquired by Dual Energy software package and an iodine map was output by the software. Analysis of the resultant images demonstrated that visualization of the ischemic region is possible due to the lack of contrast enhancement in the lower perfusion region.

18. CONCLUSION

Dual Energy System Package, CSDP-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 Dual Energy System Package, CSDP-001A, is substantially equivalent in safety and effectiveness to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare, with a bird-like design incorporated into the staff.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2014

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K132813

Trade/Device Name: Dual Energy System Package, CSDP-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 9, 2014 Received: January 10, 2014

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 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. 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 (OS) 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

. . . . . . . . .

If 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/ResourcesforYou/Industrv/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.fda.gov/MedicalDevices/Safety/ReportaProblem/delault.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.htm.

Sincerely yours,

for

Janine M. Morris 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):

K132813

Device Name:

Dual Energy System Package, CSDP-001A

Indications for Use:

Performance of this device may be affected by body size and motion artifacts.

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 Center for Devices and Radiological Health (CDRH)

Smh.7)

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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.