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 image 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.

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

Device Description

The Aquilion (TSX-101A) is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data as it and the x-ray tube rotate 360 degrees axially around a human body, Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "slice" of the body. As is common with today's CT Scanner, the Aquilion has the capability to acquire volumetric (helical) data by initiating table movement during data This data can be reconstructed per the operator's preference, to include three acquisition. dimensional rendering of the patient data. Additionally the TSX-101A is capable of CT Fluoroscopy, which is used on other Toshiba CT scanners and has received previous market clearance from the Agency. This device incorporates a standard x-ray tube and a solid state filled x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.

AI/ML Overview

The provided text is a 510(k) summary for the Aquilion CT Scanner (TSX-101A). It does not contain information about a study proving the device meets specific acceptance criteria in the way described in your request.

The document is a premarket notification (510(k)) to the FDA, demonstrating substantial equivalence to a predicate device, not a performance study report with acceptance criteria.

Therefore, I cannot provide the requested information in the format because the submission is about regulatory clearance based on substantial equivalence, rather than a clinical or performance study with defined acceptance criteria and results.

Here's a breakdown of what can be inferred from the document regarding the device and its regulatory clearance:

A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific performance metrics with acceptance criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no dedicated performance study with a test set is described.
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): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a CT scanner, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable, as this is hardware, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Clearance (from the provided text):

Device Name: Aquilion CT Scanner, TSX-101A
Intended Uses: Produce cross-sectional images of a human body by reconstruction of x-ray transmission data. Clinically useful for diagnosing various conditions including spine and head injuries, tumors, blood clots, soft tissue lesions, gastrointestinal lesions, malignancies, and musculoskeletal degeneration.
Technological Characteristics: Employs slip ring technology for continuous rotation of x-ray tube and detector, volumetric (helical) data acquisition, and CT Fluoroscopy. Uses a standard x-ray tube and solid-state filled x-ray detector. Microprocessor-based computer, hard disk storage, and display electronics are mature technologies.
Predicate Device: Toshiba TSX-011A, Xpress (K903701/A)
Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition."
Standards Conformance: IEC-60601 (Medical Device Safety) and NEMA-PS3 (DICOM Standard), alongside Quality System Regulations (21 CFR § 820).

The 510(k) process is about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new characteristics do not raise new questions of safety and effectiveness and the device is as safe and effective as the predicate device. It typically does not involve a detailed performance study with acceptance criteria in the manner you describe for a novel AI or diagnostic device.

Summary

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

AUG 26 1998

510(k) Summary

K982265

Date:	29 June 1998
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 Specialist, (714)730-5000
Establishment RegistrationNumber:	2020563
Device Proprietary Name:	Aquilion CT Scanner, TSX-101A
Common Name:	Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code: 90JXD]
Regulatory Class:	II (per 21 CFR 892.1750)
Predicate Device:	Toshiba TSX-011A, Xpress [K903701/A]
Reason For Submission	New Product

Description of this Device:

Summary of Intended Uses:

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

This device employs no intended uses that are not in cleared device already found in the marketplace.

Technological Characteristics:

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. Both of these devices produce two dimensional, black and white image that can be filmed or electronically stored for future review.

Conformance to Standards:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Additionally this system is in conformance with the applicable parts of the following Standards:

IEC-60601 - Medical Device Safety NEMA-PS3 - DICOM Standard

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive PO Box 2068 Tustin, CA 92781-2068

Re:

K982265 Aquilion CT Scanner, TSX-101A Dated: June 26, 1998 Received: June 29, 1998 Regulatory class: II 21 CFR 892,1750/Procode: 90 JAK

Dear Mr. Biggins:

AUG 26 1998

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will vertify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification i submission does not affect any obligation you might have under sections 542 of the Act for derices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitodiagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kiliai Yin
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

Page __ l __ of ______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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)

David A. Higgins

Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev

510(k) Number A782265

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.