This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

Device Description

The Multislice kit is an upgrade to previously cleared CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner [K020385]. This upgrade will allow for the collection of sixteen axial slices in one scan. This is accomplished by employing multiple solid state detectors. This methodology allows for the acquisition of high-resolution slices while maintaining the speed required to reduce anatomical motion artifacts.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "CGS-31A Multislice Upgrade Kit for Aquilion CT ScannerTSX-101A":

Based on the provided 510(k) summary and FDA clearance letter, this device is an upgrade kit for an existing CT scanner. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical performance studies with specific accuracy metrics for diagnostic tasks. The "study" here is primarily an engineering and regulatory demonstration of equivalence, not a clinical trial proving diagnostic performance against explicit acceptance criteria in the way one might expect for a new diagnostic algorithm.

Therefore, many of the requested fields related to clinical study design (sample size, ground truth, experts, MRMC, standalone performance) are not directly addressed or applicable in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (Summary)
Technological Characteristics	- Employ same principles of operation as predicate device (CGS-30A).- Generate x-radiation from x-ray tube via high-frequency controllers.- Detect x-ray transmission data with x-ray detector.- Reconstruct data by computer into 2D/3D black and white images.	"This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition."
Intended Use	- Produce cross-sectional images of the human body.- Clinically useful for diagnosis of spine/head injuries, intracranial tumors, blood clots, eye trauma, soft tissue lesions, GI lesions, abdominal/pelvic malignancies, hepatic metastases, intestinal obstructions, intra-abdominal abnormalities, musculoskeletal degeneration.- No new intended uses beyond those already cleared for predicate devices.	"This device employs no intended uses that are not in cleared devices already found in the marketplace." (Matches predicate's intended uses).
Safety	- Design and manufactured under Quality System Regulations (21 CFR § 820).- Meet all applicable requirements of Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33).- Conformance with applicable parts of IEC-60601 Medical Device Safety standards.	The submission states: "All requirements of the Federal Diagnostic Equipment Standard... will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards."
Performance (Imaging Capability)	Ability to collect sixteen axial slices in one scan, compared to the predicate's capability (implied standard of performance for multislice CT).	"This upgrade will allow for the collection of sixteen axial slices in one scan. This is accomplished by employing multiple solid state detectors."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable (N/A). The document describes an engineering and regulatory comparison to a predicate device, not a clinical "test set" in the context of diagnostic performance metrics against a gold standard. The assessment is based on design, technical specifications, and intended use equivalence.
Data Provenance: N/A. No specific patient data or images were used to demonstrate performance against clinical acceptance criteria. The "data" here refers to technical specifications, safety standards compliance, and comparison to the predicate device's design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: N/A. This type of submission relies on engineering and regulatory review rather than expert clinical review of a test set to establish ground truth for diagnostic performance. Reviewers at Toshiba and the FDA assess the technical and safety claims.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: N/A. There was no clinical test set requiring adjudication.

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. This device is a hardware upgrade for a CT scanner, not an AI-powered diagnostic tool. Therefore, an MRMC study demonstrating human reader improvement with AI assistance is not relevant or applicable.
Effect Size: N/A.

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

Standalone Performance Study: No. This device is a CT scanner upgrade, a medical imaging acquisition system. It does not perform "algorithm only" diagnostic functions in the way an AI algorithm might. Its performance is intrinsic to the image acquisition capabilities it enables.

7. The Type of Ground Truth Used

Type of Ground Truth: N/A. The "ground truth" for this 510(k) submission is the predicate device's established safety, effectiveness, and intended uses, as well as compliance with relevant engineering and safety standards. The new device demonstrates "substantial equivalence" to this established "truth." There is no clinical ground truth (like pathology or outcomes data) being established for a diagnostic task for this specific submission.

8. The Sample Size for the Training Set

Sample Size for Training Set: N/A. This is a hardware upgrade for a CT scanner, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Ground Truth Establishment for Training Set: N/A. (See point 8).

Summary of the Study Proving Acceptance Criteria:

The "study" presented in this 510(k) is a demonstration of substantial equivalence to a legally marketed predicate device (CGS-30A Multislice Upgrade kit for Aquilion CT Scanner). The basis for acceptance is that the CGS-31A upgrade kit shares identical intended uses and fundamental technological characteristics with the predicate, with the primary difference being an advancement in imaging capability (collecting sixteen axial slices instead of fewer, as implied by the "Multislice Upgrade" context and the "Major difference is the number of slices" statement).

The acceptance criteria are implicitly met by:

Stating identical intended uses to the predicate device.
Claiming similar technological characteristics (high frequency x-ray controllers, x-ray detectors, computer reconstruction) to the predicate.
Affirming compliance with Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33), and IEC-60601 Medical Device Safety standards.
Highlighting the improvement in capability (16 slices) without introducing new risks or intended uses.

The "evidence" is primarily found in the declarations made by the manufacturer in the 510(k) submission regarding its design, safety standards compliance, and comparison to the predicate device. The FDA's clearance letter confirms their agreement with this assessment of substantial equivalence. This is a common approach for modifications to existing devices within the 510(k) pathway.

Summary

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Jul 9 2002

510(k) Summary

×022056

Date:	June 5, 2002
Submitter's Name:	Toshiba America Medical Systems, Inc.
Submitter's Address:	P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068
Submitter's Contact:	Paul Biggins, Regulatory Affairs Manager, (714)730-5000
Establishment RegistrationNumber:	2020563
Device Proprietary Name:	CGS-31A Multislice Upgrade Kit for Aquilion CT ScannerTSX-101A(Aquilion Advance Multi)
Common Name:	Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code: 90JAK]
Regulatory Class:	II (per 21 CFR 892.1750)
Performance Standard:	21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard
Predicate Device(s):	CGS-30A Multislice Upgrade kit for the Aquilion CT
Reason For Submission	Modification of cleared device

· Description of this Device:

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Summary of Intended Uses:

Technological Characteristics:

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This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these systems employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. This device produces two dimensional and three dimensional, black and white images that can be filmed or electronically stored for future review.

Safety and Effectiveness Concerns:

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 § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards.

Substantial Equivalence:

Based upon the above considerations TAMS believes that this upgrade package, Multislice CT, CGS-31A, is substantially equivalent to the CGS-30A upgrade kit for Aquilion CT scanner. The major difference is the number of slices being collected in a single rotation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.

Toshiba America Medical Systems, Inc. Re: K022050 % Mr. Mark Job Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Trade/Device Name: CGS-31A Multislice Upgrade kit for Aquilion CT Scanner Model TSX-101A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: June 21, 2002 Received: June 24, 2002

Dear Mr. Job:

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); 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 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:

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" (21 CFR Part 807.97). 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,

Henry C. Brogdon

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Multislice Upgrade kit (CGS-31A) for the Aquilion CT Scanner TSX-101A Device Name:

Indications for Use:

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)	David G.
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K022050

Prescription Use ____________ OR ____________ Over-The-Counter Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

B - 5

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.