The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data. Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices - for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.

Device Description

The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data. The Imatron Ultra Access Workstation is intended for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.

AI/ML Overview

The provided text describes the "Imatron Ultra Access® Workstation with Cardiac Software Extensions" and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria with detailed performance metrics. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed devices, not on proving new clinical effectiveness or diagnostic accuracy against predefined acceptance criteria.

However, based on the information provided, I can infer the "acceptance criteria" are the features and functionalities present in predicate devices, and the "study" is the substantial equivalence comparison itself.

Here's an analysis based on the document's content:

1. Table of "Acceptance Criteria" (Predicate Device Features) and Reported Device Performance

The acceptance criteria here are derived from the features present in the predicate devices. The "reported device performance" is whether the Ultra Access Device also possesses that feature.

ITEM	FEATURE	"Acceptance Criteria" (Presence in Predicate Devices)	"Reported Device Performance" (Ultra Access Device)
1	2D image review	Yes (C150 XP, Netra MD, AIDP, VRSAPP)	Yes
	Multiplanar reformatting	Yes (C150 XP, Netra MD, AIDP, VRSAPP)	Yes
	3D surface and volume rendering	Yes (Netra MD, AIDP, VRSAPP), No (C150 XP)	Yes
	Maximum intensity projection	Yes (Netra MD, AIDP, VRSAPP), No (C150 XP)	Yes
	Performance of CTA and MRA	Yes (Netra MD, AIDP, VRSAPP), No (C150 XP)	Yes
	Image archiving	Yes (C150 XP, Netra MD, AIDP, VRSAPP)	Yes
	Image filming	Yes (C150 XP, Netra MD, AIDP, VRSAPP)	Yes
	Image transfer or network connectivity	Yes (C150 XP, Netra MD, AIDP, VRSAPP)	Yes
2	Examination of 2D image data from a calcium scan	Yes (C150 XP, Netra MD, AIDP, VRSAPP)	Yes
3	Examination of calcium scan as a 3D volume	Yes (Netra MD, AIDP), No (C150 XP, VRSAPP)	Yes
4	Semi automated identification of regions that are considered calcium	Yes (Netra MD, AIDP), No (C150 XP, VRSAPP)	Yes
5	User override of automatically identified regions	Yes (Netra MD), No (C150 XP, AIDP, VRSAPP)	Yes
6	Automatic computation of calcium score	Yes (Netra MD), No (C150 XP, AIDP, VRSAPP)	Yes
7	Ability to measure CT numbers on a 2D image	Yes (C150 XP, Netra MD, AIDP, VRSAPP)	Yes
8	Identification of mistriggered slices	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes
9	Saving of calcium data with patient exam data	Yes (C150 XP, Netra MD), No (AIDP, VRSAPP)	Yes
10	Creation of a paper calcium report	Yes (Netra MD), No (C150 XP, AIDP, VRSAPP)	Yes
11	Comparison of multiple scans	Yes (Netra MD), No (C150 XP, AIDP, VRSAPP)	Yes
12	Identification of mistriggered TDA data	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes
13	Deselection of a mistriggered image	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes
14	Identification of regions for which TDA computation should be performed	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes
15	Automatic creation of gamma-variate curve fit for TDA data	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes
16	Computation of curve parameter	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes
17	Computation of perfusion	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes
18	Creation of a parametric image	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes
19	Creation of a paper TDA report	Yes (Netra MD, AIDP), No (C150 XP, VRSAPP)	Yes
20	Indications for use - general medical imaging workstation	Yes (C150 XP, Netra MD, AIDP, VRSAPP)	Yes
21	Indication for use -- calcium	Yes (C150 XP, Netra MD, AIDP), No (VRSAPP)	Yes
22	Indication for use -- TDA	Yes (C150 XP), No (Netra MD, AIDP, VRSAPP)	Yes

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

The document does not detail a specific "test set" in the context of clinical performance evaluation (e.g., patient cases used to validate diagnostic accuracy). The "testing" mentioned ("The Ultra Access Workstation successfully passed all testing at Imatron") refers to internal verification and validation against design specifications and compliance with standards (e.g., DICOM), confirming functionality and safety aspects. It does not provide information on:

Sample size: Not specified for any performance testing.
Data provenance: Not specified.
Retrospective/Prospective: Not specified.

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

This information is not provided in the 510(k) summary. The document focuses on feature comparison and substantial equivalence, not a clinical trial involving expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable as no clinical test set with human ground truth establishment is described.

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

No MRMC study is mentioned or implied. The 510(k) summary is for a device accessory that enables advanced post-processing and display of CT images and does not claim to improve human reader performance through AI assistance as a primary output. The document states the workstation is intended "as an aid in diagnosis, including for cardiac analysis, by a trained physician," implying the physician remains in control.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study is explicitly described as a primary component of this 510(k) submission. The device is an "accessory" to a CT scanner and is an "Image Processing Workstation," meaning its function is to process and display images for a physician. Its performance is implicitly linked to its ability to accurately process and present the data as intended for clinical review, which is covered by compliance with standards and successful internal testing.

7. Type of Ground Truth Used

For the features described, the "ground truth" is largely conceptual compliance with existing standards (DICOM) and mirroring or enhancing functionalities found in predicate devices. For example, the ability to perform "Automatic computation of calcium score" (Item 6) implies an internal algorithm, but its accuracy isn't validated against external ground truth (e.g., pathology or long-term outcomes) in this document. The document notes that "new algorithms may yield more accurate results at higher flow states" for perfusion (Item 17), citing "attached scientific references," suggesting that the underlying algorithms might have been validated elsewhere or are derived from established scientific literature.

8. Sample Size for the Training Set

Not applicable. The document describes an image processing workstation with software features, not a machine learning model that requires a "training set" in the typical AI sense. The software's development likely involved traditional software engineering, testing, and potentially some algorithm development based on existing scientific principles or data characteristics, but not "training data" in the quantity and context usually associated with modern AI/ML.

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

Not applicable, as no training set for an AI/ML model is mentioned.

Summary

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K97 29 03

NOV - 4 1997

510(K) SUMMARY

Submitter's Name:

Imatron, Inc.

Address:

Phone(s):

Contact Person:

Date:

Common Names:

Proprietary Names:

Classification Name:

389 Oyster Point Blvd. South San Francisco, CA 94087

(0) 415-583-9964, ext. 206 (F) 415-827-7790

J.A. Coduto

August 8, 1997

Workstation, Image Processing Workstation, and Image Workstation

Imatron Ultra Access® Workstation with Cardiac Software Extensions

No classifications have been specifically issued No classifications have been benefits. For purposes of lor PACS of TROO ecall equivalence workstations determining substantial oquired to medical imaging devices.

The Imatron Ultrafast CT scanner is such an The "Imatron" Onraido. "Onraido. "Such, is Class II (reference: Imaging device and, as section sales Ultra Access Workstation is similarly classified.

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Predicate Device:

Device Description:

Predicate devices include: the C150XP's Physician Workstation as a component of the Imatron scanner (an Imatron, Inc. product); the NetraMD Workstation (a Scimage, Inc. product); the AIDP (Acculmage, Inc. Image Display Processor) Imatron/DICOM Image Processing Workstation (an Acculmage, Inc. product); and the VRSAPP Workstation (an ISG Technologies product).

Device Description

The Imatron Ultrafast CT Scanner --

The Imatron Ultrafast CT scanner is a scanning system (like those generically described in 21 CFR section 892.1750, which deals with "computed tomography X-ray systems") which operates by directing a focused beam of electrons along tungsten target rings to produce X-rays which pass through the body at multiple angles as in conventional CT scanning systems.

The Imatron Ultrafast CT scanner is capable of producing CT slices at rapid speeds since the data is produced by electronic rotation of the electron beam itself rather than the mechanical rotation of an X-ray tube as in conventional CT scanning systems.

the Imatron Ultrafast CT scanner Currently. operating at its highest resolution mode has 864 single or paired, contiguous X-ray detectors subtending an arc of 0.250 degrees each. The resulting 5% amplitude modulation transfer function (MTF) for high contrast objects at the center of the circle of reconstruction is 7 line pairs per centimeter (lp/cm).

Such scanner has the current ability to receive. manipulate, transmit, store, view, characterize, compare and enhance medical images.

The ISG Workstation --

The ISG Workstation is a device for picture

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archiving and communications cleared for use in processing and displaying medical images on a monitor, storing medical image data on fast access media, i.e. hard disk, and on slow access media, i.e. archive media, and transmitting data over local and wide area networks.

The Significant Modification

The only change Imatron is making to ISG's Workstation is the addition of a software package. This package is in addition to (not an amendment of) the software package currently provided with the ISG Workstation. Such package is described in detail within this 510(k) submission, as is the Workstation's intended use.

Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as the predicate devices - for receiving, are viewing, manipulating, transmitting, storing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis. by a trained physician.

See attached Substantial Equivalence Comparison and Explanation of Differences

Although there are no performance standards established by FDA for PACS devices, the Ultra Access Workstation has been designed and manufactured to meet: the ACR/NEMA Digital Imaging and Communications in Medicine (DICOM) Standard, version 3.0; and the ACR/NEMA DICOM 3.0 Digital Interchange Standard for Cardiology (DISC95-96). The device and its development

Intended Use:

Technological Characteristics:

Performance:

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process also comply with FDA's, August 29, 1991 guidance document titled: "Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".

Testing Conclusions:

The Ultra Access Workstation successfully passed all testing at Imatron. Such testing indicates that the device as described in this submission is substantially equivalent to predicated devices.

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SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

ﺴﻴﺴﻪ:

Following in tabular (Table 2) and explanation form is a comparison of the similarities and differences that exist betweer the subject device and the predicate devices.

TABLE 2: COMPARISON OF FEATURES AND SPECIFICATIONS
----------------------------------------------------	--	--

ITEM	FEATURE	ULTRA ACCESSDEVICE	C150 XPDEVICE	NETRA MDDEVICE	AIDPDEVICE	VRSAPPDEVICE
1	2D image review	Yes	Yes	Yes	Yes	Yes
	Multiplanar reformatting	Yes	Yes	Yes	Yes	Yes
	3D surface and volumerendering	Yes	No	Yes	Yes	Yes

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ITEM	FEATURE	ULTRA ACCESSDEVICE	C150 XPDEVICE	NETRA MDDEVICE	AIDPDEVICE	VRSAPPDEVICE
	Maximum intensityprojection	Yes	No	Yes	Yes	Yes
	Performance of CTA andMRA	Yes	No	Yes	Yes	Yes
	Image archiving	Yes	Yes	Yes	Yes	Yes
	Image filming	Yes	Yes	Yes	Yes	Yes
	Image transfer or networkconnectivity	Yes	Yes	Yes	Yes	Yes
2	Examination of 2D imagedata from a calcium scan	Yes	Yes	Yes	Yes	Yes
3	Examination of calciumscan as a 3D volume	Yes	No	Yes	Yes	No

)

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ITEM	FEATURE	ULTRA ACCESSDEVICE	C150 XPDEVICE	NETRA MDDEVICE	AIDPDEVICE	VRSAPPDEVICE
4	Semi automatedidentification of regionsthat are consideredcalcium	Yes	No	Yes	Yes	No
5	User override ofautomatically identifiedregions	Yes	No	Yes	No	No
6	Automatic computation ofcalcium score	Yes	No	Yes	No	No
7	Ability to measure CTnumbers on a 2D image	Yes	Yes	Yes	Yes	Yes
8	Identification ofmistriggered slices	Yes	Yes	No	No	No
9	Saving of calcium data withpatient exam data	Yes	Yes	Yes	No	No
ITEM	FEATURE	ULTRA ACCESSDEVICE	C150 XPDEVICE	NETRA MDDEVICE	AIDPDEVICE	VRSAPPDEVICE
10	Creation of a papercalcium report	Yes	No	Yes	No	No
11	Comparison of multiplescans	Yes	No	Yes	No	No
12	Identification ofmistriggered TDA data	Yes	Yes	No	No	No
13	Deselection of amistriggered image	Yes	Yes	No	No	No
14	Identification of regions forwhich TDA computationshould be performed	Yes	Yes	No	No	No
15	Automatic creation ofgamma-variate curve fit forTDA data	Yes	Yes	No	No	No
16	Computation of curveparameter	Yes	Yes	No	No	No
17	Computation of perfusion	Yes	Yes	No	No	No
ITEM	FEATURE	ULTRA ACCESSDEVICE	C150 XPDEVICE	NETRA MDDEVICE	AIDPDEVICE	VRSAPPDEVICE
18	Creation of a parametricimage	Yes	Yes	No	No	No
19	Creation of a paper TDAreport	Yes	No	Yes	Yes	No
20	Indications for use-general medical imagingworkstation	Yes	Yes	Yes	Yes	Yes
21	Indication for use --calcium	Yes	Yes	Yes	Yes	No
22	Indication for use -- TDA	Yes	Yes	No	No	No

)

ﺮ ﺮ

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ITEM 3: REFORMATTING VS. SHADED SURFACE DISPLAY. Reformatting and shaded surface display are both well accepted methods of examining volumetric data. Gray scale information is lost in a shaded surface display, but because we are looking at high-contrast areas (calcium vs. surrounding tissue), gray scale information is not required. This difference does not affect safety or efficacy.

ITEM 4: FOOTPRINT IDENTIFICATION VS. COLORED SHADED SURFACE. Large contrast difference exist between calcified regions and soft tissue. Therefore, these regions can be identified equally readily on a maximum intensity projection (footprint method) or in a shaded surface display. We have chosen to use a 3D display because the spatial relationships between calcified regions are more clearly observable in a 3D display, and thus calcified regions in arteries and in non-arteries can be more clearly identified. This difference does not affect safety or efficacy.

ITEM 9: SAVING OF 3D DESCRIPTIONS VS. ROIS. The location of calcified regions can be stored as a set of (x, y, z) coordinates or as a set of (x, y, slice position) coordinates. In an axial scanning modality like CT, slice position and the z coordinate are proportional, and thus this difference does not affect safety or efficacy.

ITEM 10: VIEWING OF REPORT DATA IN MICROSOFT WORD OR IN NETSCAPE. Both methods allow a user to view text and image data, and to print these data onto paper. This difference does not affect safety or efficacy.

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ITEM 11: VIEWING OF DUAL-SCANS ON SAME SHEET OR ON TWO-DIFFERENT SHEETS. Both methods allow for side-by-side comparison of two calcium scans. No functional difference is obtained by using two sheets of paper or one. This difference does not affect safety or efficacy.

ITEM13: USE/NO-USE VS. CLICKING ON AN IMAGE TO INDICATE DESELECTION. Both methods allow the user to tell the software which images to ignore when performing the subsequent gamma-variate curve fit. Ultra Access uses a more graphical approach (clicking on the image) to make it easier for the user to determine which slices were deselected and which were not. This difference does not affect safety or efficacy.

ITEM 17: SUPPORT OF 1 PERFUSION ALGORITHM OR 4. Ultra Access supports the perfusion algorithm used in the predicate device's software. However, as shown by the attached scientific references, other newer algorithms may vield more accurate results at higher flow states. Therefore, these additional algorithms have been provided. This difference does not affect safety or efficacy.

ITEM 18: GRAYSCALE VS. COLOR PARAMETRIC IMAGES. Both systems support grayscale mappings of curve parameter values. However, as the human eye can better perceive subtle changes in color than it can subtle changes in gray values, we have also provided color mappings. This approach is identical to that used in Nuclear Medicine or in PET scanning. We also support the colored display of perfusion. This parameter is being computed by the predicate device, but only being displayed as a number (as opposed to a colored map). Ease of use will be enhanced by displaying this additional parameter in color. This difference does not affect safety or efficacy.

ITEM 20: PAPER PRINTOUT MAP OF TDA REPORT. The predicate device creates paper reports describing the results of a calcium scan. In addition to supporting this type of printout in Ultra Access (see Item #10), Ultra Access will also create paper reports of TDA data. The data being placed on paper is identical to the data being computed by the C150XP predicate device, and therefore placing this information on paper (using a color ink) et printer to preserve color information) does not change its clinical meaning. This difference does not affect safety or efficacy.

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Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HU" are arranged in a semi-circle around the left side of the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 1997

J. A. Coduto Director, Regulatory Affairs Imatron, Inc. 389 Oyster Point Blvd. South San Francisco, CA 94080 Re: K972903 Imatron Ultra Access Workstation with Cardiac Software Extensions Dated: August 8, 1997 Received: August 6, 1997 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Coduto:

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 (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 requirement, as set forth in the Ouality System Regulation (OS) 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing 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 question 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/dsmamain.html".

Sincerely yours,

W.Liau Yu

Lillian Yin, Ph.D. 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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SECTION 3: PROPOSED INTENDED USE STATEMENT

Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices - for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.

David A. Bergman

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

Prescription Use
(Per 21 CFR 801.109)

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.