(72 days)
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
The Asteion (TSX-021A) 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 Asteion 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-021A 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 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.
This 510(k) summary describes a CT scanner (Asteion CT Scanner, TSX-021A) which is a "New Product" and appears to leverage substantial equivalence to a predicate device (Toshiba TSX-011A, Xpress [K903701/A]). The context of this document is a regulatory submission for market clearance, rather than a detailed performance study like those for AI/CADe devices. As such, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance metrics for AI/CADe devices is not directly applicable or available in this document.
Instead, the "acceptance criteria" for a traditional medical device like a CT scanner in a 510(k) submission primarily revolve around substantial equivalence to a predicate device and conformance to established standards for safety and performance (not algorithmic performance). The "study" proving this typically involves comparisons of technological characteristics and intended uses, along with adherence to manufacturing regulations and recognized standards.
Here's an attempt to answer your questions based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a traditional device 510(k) submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Interpreted for a 510(k) Submission) | Reported Device Performance/Characteristics |
|---|---|
| Substantial Equivalence to Predicate Device | "This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition." - Explicitly states substantial equivalence in technological characteristics. |
| Intended Uses Align with Cleared Devices | "This device employs no intended uses that are not in cleared devices already found in the marketplace." - The intended uses (cross-sectional imaging of the human body, diagnosis of various conditions as listed) are explicitly stated to be consistent with existing cleared devices. |
| Safety and Quality System Conformance | "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." |
| Technological Characteristics | Employs high frequency x-ray controllers, detects x-ray transmission data, reconstructs data by computer, produces two-dimensional black and white images. Incorporates slip ring technology for continuous rotation. Capable of volumetric (helical) data acquisition. Capable of CT Fluoroscopy (previously cleared). Uses standard x-ray tube and solid-state x-ray detector. Microprocessor-based computer, hard disk storage, display electronics (mature technologies). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. A 510(k) for a CT scanner typically doesn't involve clinical "test sets" in the same way an AI/CADe device would. Performance is generally demonstrated through engineering testing, compliance with standards, and comparison to the predicate device's established performance, rather than a clinical trial with a specific patient dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided and is not relevant for this type of device submission. Ground truth establishment by experts is a typical requirement for AI/CADe devices to assess diagnostic accuracy, which is not the focus of this CT scanner's 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not relevant for this type of device submission.
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
This information is not provided and is not relevant for this type of device submission. MRMC studies are used for evaluating the impact of AI/CADe assistance on human reader performance, which does not apply to a standalone CT imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not relevant for this type of device submission. The CT scanner itself is the device; it does not contain an "algorithm only" component that would be evaluated for standalone performance in this context. Its performance is its ability to acquire and reconstruct images conforming to specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided and is not relevant for this type of device submission.
8. The sample size for the training set
This information is not provided and is not relevant for this type of device submission. Training sets are pertinent to machine learning algorithms.
9. How the ground truth for the training set was established
This information is not provided and is not relevant for this type of device submission.
In summary: The provided document is a 510(k) summary for a conventional CT scanner. The "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to a predicate device and adherence to recognized safety and quality standards, rather than clinical performance metrics derived from patient data analysis typically associated with AI/CADe device submissions.
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OCT 21 1998
510(k) Summary
| Date: | 5 August 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: | Asteion CT Scanner, TSX-021A |
| Common Name: | Scanner, Computed Tomography, X-Ray JAK[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:
The Asteion (TSX-021A) 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 Asteion 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-021A 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 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.
Summary of Intended Uses:
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.
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This device employs no intended uses that are not in cleared devices 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
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that suggest movement and flight. The overall design is simple and clean, with a focus on the eagle as a symbol of strength and freedom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive PO Box 2068 Tustin, CA 92781-2068
Re: K982787
Asteion CT Scanner. TSX-021A Dated: August 5, 1998 Received: August 10, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Biggins:
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 Federal Food, Drug, and Cosmetic Act (Act. Xou 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 sanst 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 equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (11-CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices 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 OFR Part 801 and additionally 809:10 for in vitro diagnostic 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/cdrf/dsmaldsmamain.html".
Sincerely yours,
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
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ____Asteion CT Scanner_TSX-021A
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)
Gamil A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
Prescription Use _ 1 (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.