The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.)

The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.

Angio-CT MIYABI is a combined system, which allows interventional radiological techniques, and whole body x-ray computed tomography scanning on a single patient without moving the patient from one table to another especially after or during interventional procedure performed under image intensified visualization (e.g. stenting, coiling, local chemical therapy, embolization).

Device Description

The Angio-CT MIYABI system is a combination of a CT and an Angiography system The SOMATOM Plus 4 system is a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.

AI/ML Overview

The provided text describes the Angio-CT MIYABI system, which combines a CT and an Angiography system. However, it does not include details about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for substantial equivalence.

Therefore, I cannot populate the table or answer most of the questions using the provided text. The submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than providing performance data against predefined acceptance criteria for the combined system.

Here's what I can extract based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria Value	Reported Performance
Intended Use Equivalence	To perform interventional radiological techniques and whole-body x-ray computed tomography scanning on a single patient without movement, especially during or after interventional procedures (e.g., stenting, coiling, local chemical therapy, embolization).	The Angio-CT MIYABI is a combined system that allows interventional radiological techniques and whole-body x-ray computed tomography scanning on a single patient without movement, especially after or during interventional surgery (e.g., stenting, coiling, local chemical therapy, embolization).
Technological Characteristics Equivalence	Combination of a CT (SOMATOM Plus 4) and an Angiography system (Multistar Plus).	The Angio-CT MIYABI system is a combination of a CT and an Angiography system, specifically the SOMATOM Plus 4 and Multistar Plus.
Safety Standards Compliance	Meet 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard; 21 CFR § 1020.30 and § 1020.33; ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1; UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.	All components are certified to meet these requirements. The SOMATOM is designed to meet IEC 601-1 and UL 187. An initial report as per 21 CFR § 1002.10 will be filed.
Substantial Equivalence (to predicate devices)	Operating with SOMARIS 4 (SOMATOM Plus 4) and SW-Version 3.0 (Multistar Plus) software, substantially equivalent to the SOMATOM Plus 4 and Multistar Plus systems with Koordinat M in commercial distribution.	Deemed substantially equivalent to the SOMATOM Plus 4 and Multistar Plus systems with Koordinat M (in commercial distribution) by the FDA.
Diagnostic Image Quality (e.g., resolution, contrast)	Not specified in the provided text.	Not specified in the provided text.
Accuracy of Procedures (e.g., precise localization for interventions)	Not specified in the provided text.	Not specified in the provided text.
Radiation Dose Levels	Not specified in the provided text.	Not specified in the provided text.

Detailed Answers to Specific Questions:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The document is a 510(k) submission for substantial equivalence. It does not describe a clinical study generating specific performance data against a test set. Equivalence is primarily based on comparing the new device's technical characteristics and intended use to existing predicate devices.

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)

Not applicable / Not provided. No specific clinical study or test set with expert-established ground truth is described.

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

Not applicable / Not provided. No specific clinical study or test set requiring adjudication is described.

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

No. This document describes a combined imaging system, not an AI-assisted diagnostic tool. There is no mention of an MRMC study or AI assistance.

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

No. This device is a medical imaging system (CT and Angiography), not an algorithm with standalone performance.

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

Not applicable / Not provided. No specific clinical “ground truth” from a study is mentioned. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable / Not provided. This document does not describe a machine learning algorithm that would have a "training set."

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

Not applicable / Not provided. As there's no training set mentioned, this question is not relevant to the provided text.

Conclusion based on the provided text:

The provided document is a 510(k) summary focused on demonstrating the substantial equivalence of the Angio-CT MIYABI system to already marketed CT and Angiography systems. It does not contain information about a specific performance study against defined acceptance criteria for the combined system beyond compliance with regulatory standards and the equivalence of its technical characteristics and intended use to its predicate devices. There is no mention of AI, machine learning, or detailed clinical efficacy trials with expert ground truth or test sets.

Summary

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Attachment 1

K990491

Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I. General Information

Device Name:	Angio-CT MIYABI
Classification Name:	§ 892.1750:Computed tomography X-ray system§ 892.1600Angiographic x-ray system
Propriety Trade Name:	Angio-CT MIYABI
Classification:	Class II
Performance Standards:	21 CFR Subchapter J, FederalDiagnostic X-ray Equipment Standard
Establishment Regist. Number:	2240869
Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, NJ 08830
Contact Person:	Kathleen M. RutherfordManager, Regulatory Submissions(732) 321-4779

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SIEMENS

II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

Device Description:

Intended Use:

The SOMATOM Plus 4 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the sliding gantry). The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.

Angio-CT MIYABI is a combined system, which allows interventional radiological techniques, and whole body x-ray computed tomography scanning on a single patient without moving the patient from one table to another especially after or during interventional surgery (e.g. stenting, coiling, local chemical therapy, embolization).

Technological Characteristics:

The Angio-CT MIYABI system is a combination of a CT and an Angiography system.

General Safety and Effectiveness Concerns:

All components of the Angio-CT MIYABI system subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33 are certified to meet those requirements; and an initial report as per 21 CFR § 1002.10 will be filed with the Center for Devices and Radiological Health (CDRH). To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice. The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.

Substantial Equivalence:

The Angio-CT MIYABI operating with SOMARIS 4 (SOMATOM Plus 4) and SW-Version 3,0 (Multistar Plus) software is substantially equivalent to the SOMATOM Plus 4 and Multistar Plus systems with Koordinat M in commercial distribution.

Kathleen Rutherford
Signature

2/16/99
Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 5 1999

Alicia Bustos-Juergensen Technical Specialist Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

K990491 Angio-CT MIYABI Dated: February 16, 1999 Received: February 17, 1999 Regulatory classs: II 21 CFR 892.1600/Procode: 90 IXI 21 CFR 892.1750/Procode: 90 JAK

Dear Ms. Bustos-Juergensen:

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 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). 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 (QS) for Medical Devices: General regulation (21 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(t) 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 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 requlation 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indication for use

996491

510(k) Number (if known):

Device Name:

Angio-CT MIYABI

Indication for use:

The Multistar Plus is a ceiling-suspended double C-arm for single plane general vascular imaging as well as interventional techniques.

David A. Seigman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 892.5710 Radiation therapy beam-shaping block.

(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.