The software can be used with ultrasound systems previously cleared for Bmode imaging in obstetrics, gynecology, small organ, abdominal, endocavity, neuriological, and intraoperative uses.

Device Description

The Fetal Assessment CAP® 1.1 is a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 operating system standards. Fetal Assessment CAP® 1.1 is proprietary software for the analysis, storage, retrieval and reconstruction of ultrasound B-mode images.

The data can be acquired by a TomTec acquisition station or B-mode (2D) acquisition capable Ultrasound systems. With the Fetal Assessment CAP a 3 dimensional display can be reconstructed.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Fetal Assessment CAP® 1.1" software. It focuses primarily on the device description, its intended use, comparison to a predicate device, and a general statement about testing.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Design Intent	Device performance satisfies design intent.
System Performance Specifications	Device performance conforms to system performance specifications.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified. The document states "Testing was performed according to internal company procedures" and "Software testing and validation were done at the module and system level." This does not provide details on the number of cases or images used.
Data Provenance: Not specified. There is no mention of where the data came from (e.g., country of origin, specific clinics) or whether it was retrospective or prospective.

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 in the document. The text only mentions "Test results were reviewed by designated technical professionals before software proceeded to release," but it does not specify the number or qualifications of these professionals, nor does it explicitly state they established "ground truth" for the test set in a medical sense.

4. Adjudication method for the test set

This information is not provided in the document.

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, an MRMC comparative effectiveness study was not done or at least not described. The submission is for a standalone software module that reconstructs 3D images. It states, "the Fetal Assessment CAP is a simple to use, qualitative 3D ultrasound tool, which provides 3D structures without any measurement functionality." There is no mention of human readers using the system in a comparative effectiveness study.

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

Yes, a standalone performance assessment was done. The document describes the Fetal Assessment CAP as "proprietary software for the analysis, storage, retrieval and reconstruction of ultrasound B-mode images" and "can import digital 2D or 3D image file formats for 3D display." The testing focused on whether the software itself satisfied its design intent and conformed to system specifications. The "performance" described is the functionality of the software to process and display images, rather than a diagnostic performance metric.

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

The term "ground truth" in a medical context (e.g., confirmed diagnosis by pathology) is not applicable here. The software's function is "3 dimensional display" and "reconstruction" of ultrasound images, without measurement functionality. The "ground truth" for this type of device would likely relate to the accuracy and fidelity of the 3D reconstruction based on the input 2D data, and the correct functioning of storage, retrieval, and analysis features. The document states "Test results were reviewed by designated technical professionals," implying validation against the software's specified functional requirements rather than medical ground truth.

8. The sample size for the training set

This information is not provided. As the device is referred to as "proprietary software for the analysis, storage, retrieval and reconstruction of ultrasound B-mode images," and not explicitly an AI/ML algorithm (especially given the 1999 date), it's possible there wasn't a "training set" in the modern sense of machine learning. The focus was on software validation.

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

This information is not provided, and as noted above, a distinct "training set" with established ground truth as understood in current AI/ML might not have been relevant or formalized for this type of software in 1999.

Summary

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

OCT 1 8 1999

Image /page/0/Picture/3 description: The image shows the logo for TOMTEC IMAGING SYSTEMS. The logo is in black and white, with the word "TOMTEC" in large, bold letters. Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent a company that specializes in imaging technology.

K 992580 81072

July 23, 1999

510(k) Summary Fetal Assessment CAP

Name and Address

Acuson Corporation 1220 Charleston Road Mountain View, CA 94043

Contact Person

William E. Welch Manager, Regulatory Affairs Phone (650) 969-9112 FAX (650) 962-8018

Common, Classification & Proprietary Names

Common Name:	Digital Ultrasound Image Analysis System
Classification Name:	Ultrasonic Pulsed Echo Imaging System
Proprietary Name:	Fetal assessment CAP or 3D Surface Rendering

Predicate Device

TomTec Echo-View K934139

Device Description

The data can be acquired by a TomTec acquisition station or B-mode (2D) acquisition capable Ultrasound systems. With the Fetal Assessment CAP a 3 dimensional display can be reconstructed.

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

Image /page/1/Picture/2 description: The image shows the logo for TOMTEC Imaging Systems. The logo is in black and white, with the word "TOMTEC" in large, bold letters. Below the word "TOMTEC" are the words "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.

Intended Use

Fetal Assessment CAP@ 1.1 is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional image processing.

Fetal Assessment CAP can import digital 2D or 3D image file formats for 3D display.

The software can be used with ultrasound systems previously cleared for Bmode imaging in obstetrics, gynecology, small organ, abdominal, endocavity, neuriological, and intraoperative uses. I

Technological Characteristics Comparison

The Fetal assessment Cap is mainly a clinical application oriented set of the Echo-View system. The Acquisition methods are comparable to the EchoScan Acquisition methods. While the EchoView system provides diverse measurement functions, the Fetal Assessment CAP is a simple to use, qualitative 3D ultrasound tool, which provides 3D structures without any measurement functionality.

Test Discussion

Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release.

Test Conclusions

Test results support the conclusion that actual device performance satisfics the design intent. Actual device performance as tested internally conforms to the system performance specifications.

July 23, 1999 William E. Welch

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 1999

William E. Welch Manager, Requlatory Affairs Acuson Corporation 1220 Charleston Road P.O. Box 7393 Mountain View, CA 94039-7393 Re: K992580

3D Surface Rendering and Fetal Assessment CAP (Clinical Application Package) Dated: July 27, 1999 Received: August 2, 1999 Requiatory Class: Il 21 CFR 892.1560/Procode: 90 IYO

Dear Mr. Welch:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (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 oblication 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 yitro 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

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

K 992580

Diagnostic Ultrasound Indications for Use Form

Ultrasound System: See Comments Below

Transducer: See Comments Below

ClinicalApplications	B	ColorDoppler
Ophthalmic
Fetal	P
Abdominal	P
Intra-operative(Specify)	P
Intra-operativeNeurological	P
Pediatric	P
Small Organ- Thyroid	P
- Breast- Testicle	P
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal	P
Trans-Vaginal	P
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Specify)N = New Indication		P = Previously cleared by FDAE = Added under Appendix E

Additional Comments:_3D_Surface_Rendering_software can be used with any previously cleared ultrasound system and transducers capable of B-mode imaging and cleared for the above indications for use.

PI FASE DO NOT WRITE REI OW THIS I INF CONTINITIE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Yes

David A. Seymore
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Dey 510(k) Number

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.