The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.

Device Description

The EchoTech 3D FreeScan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a commercially available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.

2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, comprehensive study results, or the methodologies for establishing ground truth as requested in the prompt. The document is a 510(k) summary for the EchoTech 3D FreeScan, which primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

However, I can extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in quantitative terms.	"Actual device performance satisfies the design intent."
"Actual device performance... conforms to the system performance specifications."
	"nearly identical in performance and intended use to the TomTec EchoScan" (Predicate Device: TomTec Echo-Scan K963807)

Missing Information: Specific quantitative acceptance criteria (e.g., accuracy, precision, speed, specific image quality metrics) are not provided. The performance is broadly stated as meeting "design intent" and "system performance specifications" without detailing what those specifications are.

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

Missing Information: The document does not specify the sample size used for the test set. It mentions "software testing and validation" and "additional system testing by a third party standards test house" but does not quantify the data used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

Missing Information: The document does not describe the establishment of a "ground truth" for a test set, nor does it mention the involvement or qualifications of experts in this capacity. The testing appears to be internal validation against design specifications rather than clinical performance evaluation against expert-derived ground truth.

4. Adjudication Method for the Test Set

Missing Information: No adjudication method is mentioned or implied, as there is no description of a clinical test set requiring expert consensus.

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

Missing Information: The document does not describe an MRMC comparative effectiveness study. The device is presented as an "add-on accessory" for acquiring and reconstructing 3D ultrasound data, not as an AI-driven diagnostic aid for human readers. Therefore, there is no mention of an effect size related to human reader improvement with or without AI assistance.

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

Information Provided (Indirectly): The "Test Discussion" states that "Software testing and validation were done at the module and system level" and "Additional system testing was done by a third party standards test house." This suggests standalone testing of the algorithm (or software components) against its design specifications was performed.
Missing Information: The specific metrics and results of this standalone performance are not detailed beyond a general statement of compliance.

7. The Type of Ground Truth Used

Missing Information: The document does not specify a type of "ground truth" (e.g., pathology, outcomes data, expert consensus) as would be relevant for clinical performance evaluation. The testing described appears to be focused on validating the device's technical functionality and conformity to internal design specifications.

8. The Sample Size for the Training Set

Missing Information: The document does not mention a training set. This device is described as an image acquisition, analysis, storage, and retrieval system for 3D ultrasound, not an AI/ML-based diagnostic algorithm that would typically require a training set.

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

Missing Information: As no training set is mentioned, the method for establishing its ground truth is also not applicable or discussed.

Summary

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6 1998 MAY

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Image /page/0/Picture/1 description: The image contains a handwritten string of characters. The string appears to be "K980308". The characters are written in a dark ink on a white background.

January 23, 1998

510(k) Summary EchoTech 3D FreeScan

Submitter (Consultant) Name and Address

Morningstar Consulting Group, Inc. P. O. Box 218 Indian Hills, CO 80454

Submitter (Consultant) Contact Person

Kevin Morningstar, Senior Consultant phone (303) 697-8198 fax: call first

Manufacturer Name and Address

EchoTech 3D Imaging Systems GmbH Zeppelinstr. 4 D-85399 Hallbergmoos Germany

Manufacturer Contact Person

Peter Wiczek, Product Line Manager Phone 49 811 5556 0 fax 49 811 5556 20

Common, Classification & Proprietary Names

Common Name: Classification Name: Proprietary Name:

Digital Ultrasound Image Analysis System Ultrasonic Pulsed Echo Imaging System EchoTech 3D FreeScan

P-2

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Predicate Device

TomTec Echo-Scan K963807 dated December 18, 1996.

Device Description

Intended Use

Technological Characteristics Comparison

The EchoTech 3D FreeScan is nearly identical in performance and intended use to the TomTec EchoScan, except that the EchoScan features an assortment of computer controlled probe carriage devices and incorporates respiration gating.

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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. Additional system testing was done by a third party standards test house.

Test Conclusions

Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by a third party conforms to the system performance specifications.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, with its wings forming three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C 1398 MAY

EchoTech 3D Imaging Systems GmbH c/o Kevin Morningstar, Senior Consultant Morningstar Consulting Group, Inc. P.O. Box 218 Indian Hills, CO 80454

Re:

K980308 EchoTech 3D FreeScan Dated: April 4, 1998 Received: April 6, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO

Dear Mr. Morningstar:

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 requirements, as set forth in the Quality 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 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/odrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

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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K 980308

510(k) Number (if known):

ECHOTECH 3D FreeScan Device Name:

Indications for Use:

The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ritle LOTOTEON of 11000an of econstruction of diagnostic ultrasound images. It is ultrasound images and 3 differial retrieve digital ultrasound images for computerized 3-Intended to acquire, analyze, other and rother accessory for existing ultrasound imaging dimensional intego prococeing to to arritorn and movement of ultrasound transducers for the systems, and is michaod to room poal image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, intendou as a general parpos angery, orthopedics, oncology, obstetrics and gynecology.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jamil A. Segerson

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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.