This software is designed to be used in combination with the Toshiba GMS-5500A/UI Nuclear Medicine Medical Image Processor. The software matches the position and size of two tomographic images acquired for the brain of the same patient and superimposes them for display. Nuclear medicine, CT, and MRI images can be processed using this software. This software can be used to perform registration between images of two different modalities and superimpose them. This device employs no intended uses that are not in cleared devices already found in the marketplace.

To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
Tomographic Imaging (SPECT) for non Positron Emitter

Device Description

The Automatic Image Registration Software, Model NSFU-050A is a software option for the Toshiba GMS-5500A/UI Nuclear Medical Image Processor. The software matches the position and size of two tomographic images acquired for the same patient and superimposes them for display.

AI/ML Overview

The provided 510(k) summary for the Toshiba Automatic Image Registration Software, Model NSFU-050A, does not contain detailed information about acceptance criteria, specific device performance metrics, or study methodologies that would allow for a comprehensive breakdown as requested. This document is a premarket notification for substantial equivalence, which primarily focuses on comparing the new device to legally marketed predicate devices based on intended use and technological characteristics rather than providing in-depth performance study results.

However, based on the absence of such information in this specific 510(k), we can infer several points relevant to your questions.

Here's an analysis of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
(No quantitative metrics or performance targets are listed in the 510(k) summary.)	(The 510(k) summary states that the device "matches the position and size of two tomographic images acquired for the same patient and superimposes them for display." It also notes that "multimodality image fusion is well understood and is documented in peer reviewed scientific publications." However, no specific performance data, such as accuracy in registration, processing speed, or user-reported satisfaction, is provided for this specific device in the summary.)

Acceptance Criteria

Reported Device Performance

Not specified

(No quantitative metrics or performance targets are listed in the 510(k) summary.)

(The 510(k) summary states that the device "matches the position and size of two tomographic images acquired for the same patient and superimposes them for display." It also notes that "multimodality image fusion is well understood and is documented in peer reviewed scientific publications." However, no specific performance data, such as accuracy in registration, processing speed, or user-reported satisfaction, is provided for this specific device in the summary.)

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

Sample Size: Not specified. The 510(k) summary does not mention any specific test set or the number of cases/patients used to evaluate the device's performance.
Data Provenance: Not specified. There is no information regarding the country of origin of data or whether any testing was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The summary does not provide any details about experts or how ground truth was established for any performance testing.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Since no test set or ground truth establishment is described, no adjudication method is mentioned.

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

MRMC Study: Not reported. The 510(k) summary does not mention any MRMC study or any comparison of human reader performance with or without AI assistance. This type of study would typically involve a human-in-the-loop component, which is not a focus of the provided summary for this image registration software.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Not explicitly described as a formal study. While the device itself is a standalone software component, the 510(k) summary does not present specific performance metrics from a standalone study. It focuses on the device's function (matching and superimposing images) and its substantial equivalence to predicate devices, implying its ability to perform this function, but without quantitative evidence for this specific submission.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified. There is no indication of whether expert consensus, pathology, outcomes data, or any other method was used to establish ground truth for testing.

8. Sample Size for the Training Set

Sample Size: Not specified. The 510(k) summary does not provide any information about a training set, suggesting that the submission does not rely on a machine learning model that requires a dedicated training set in the modern sense. Given the 1999 date, this is consistent with software development practices of that era, where rule-based or algorithmic approaches were more common and typically didn't involve "training sets" in the current AI/ML context.

9. How Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable/Not specified. Since no training set is mentioned (see point 8), there's no information on how its ground truth would have been established.

Summary of what the 510(k) does communicate regarding evidence for meeting intended use:

The 510(k) for the Toshiba Automatic Image Registration Software, Model NSFU-050A, primarily relies on substantial equivalence to predicate devices. It asserts that:

The device's intended uses are not new and are found in already cleared devices (predicate devices: Toshiba GMS-5500A/UI Nuclear Medicine Image Processor and ADAC Image Fusion and Review System).
The technological characteristics are "the same as that of the predicate devices."
"Multimodality image fusion is well understood and is documented in peer-reviewed scientific publications."

This suggests that rather than providing a detailed performance study with specific acceptance criteria and outcome metrics for this new product, the submission argues that the underlying technology and its application are already proven and legally marketed through the predicate devices. The FDA's clearance (DEC - 3 1999) indicates acceptance of this argument for substantial equivalence.

Summary

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

K92992

510(k) Summary

Date:	September 3, 1999
Submitter's Name:Submitter's Address:	Toshiba America Medical Systems, Inc.P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068
Submitter's Contact:	Diana Thorson, Regulatory Affairs Specialist,(714)730-5000, Extension 4121
Device Proprietary Name:Classification Name:Common Name:	Automatic Image Registration Software, Model NSFU-050AEmission Computed Tomography SystemGamma Camera Option[Fed. Reg. No. 892.1200, Pro. Code: 90 KPS]
Predicate Devices:	Toshiba GMS-5500A/UI Nuclear Medicine Image Processor(K931297)ADAC Image Fusion and Review System (K973233)
Reason for Submission	New option for existing product

Description of this Device:

DEC - 3 1999

Summary of Intended Uses:

Technological Characteristics:

The technological characteristics of this device are the same as that of the predicate devices. Multimodality image fusion is well understood and is documented in peer reviewed scientific publications.

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

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures connected by flowing lines, representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1999

Diana Thorson Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781-2068

Re:

K992992 Automatic Image Registration Software Model NSFU-050A Dated: September 3, 1999 Received: September 7, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Ms. Thorson:

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 (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. Ilsting 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(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 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/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

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

510 (k) Number (If Known):

992 992

Toshiba Image Registration Software, Model NSFU-050A Device Name:

Nuclear Medicine Device

Indications For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).

		YES	NO	Energy Range (keV)
A.	Planar Imaging		X
B.	Whole Body Imaging		X
C.	Tomographic Imaging (SPECT) for non Positron Emitter	X		50-400
D.	Positron Imaging by Coincidence
E.	Positron Imaging without Coincidence		X
F.	Positron Whole Body Imaging by Coincidence		X

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510 (k) Number:

K992992

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.