The Life Imaging Systems L3Di 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 such as distance, area, volume and angle measurements. 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 radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.

Device Description

The Life Imaging Systems L3Di is a high performance computer system based on Apple Computer and Windows NT 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 during use, either with transducer positioner assemblies or with a 6-degree of freedom coordinate tracking system.

AI/ML Overview

The provided document for K990560, the Life Imaging Systems L3Di, is a 510(k) summary and FDA clearance letter. It does not contain a detailed study report with specific acceptance criteria or performance metrics in a structured table, nor does it provide the detailed information requested regarding sample sizes, ground truth establishment, or expert qualifications for a clinical performance study.

Based on the provided text, here's what can be extracted and inferred:

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

No explicit acceptance criteria or performance metrics are detailed in a table format. The document states:

Acceptance Criteria (Implied): The device's performance should satisfy the "design intent" and conform to "system performance specifications."
Reported Device Performance: "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."

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

Sample Size: Not specified.
Data Provenance: Not specified. The testing was done "internally" and by a "third party standards test house."

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 specified. The document only mentions that "Test results were reviewed by designated technical professionals." Their number and qualifications are not detailed, and it's unclear if these professionals established a "ground truth" in the clinical sense, or merely reviewed engineering test results.

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

Not specified.

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 MRMC comparative effectiveness study is mentioned. This device is described as an "add-on accessory" for acquiring, analyzing, and processing 3D ultrasound images, and its functionality appears to be focused on image reconstruction and measurement tools rather than AI-assisted diagnosis for human readers.

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

The document implies that the "software testing and validation" and "additional system testing" would be considered similar to a standalone evaluation of the device's technical performance against its specifications. However, no specific details are provided on how this "standalone performance" was quantified or measured for clinical efficacy.

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

Not specified. Given the device's function (image acquisition, 3D reconstruction, analysis, and measurement), the "ground truth" for technical validation would likely involve comparing the device's output (e.g., reconstructed 3D images, measured distances, volumes) against known physical properties of test phantoms or highly accurate reference measurements, rather than clinical ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable/Not specified. The document describes software "validation" and "testing," which refers to evaluating the software's functionality and adherence to specifications, not machine learning model training. There is no indication that this device uses AI/ML that requires a training set.

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

Not applicable/Not specified, as there is no mention of a training set for an AI/ML model.

Summary based on the document:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (LIS 6000A) based on technological characteristics and intended use. The "Test Discussion" and "Test Conclusions" describe internal software validation and system testing by a third party to ensure the device meets its design intent and performance specifications. This appears to be a technical validation rather than a clinical performance study with human readers, specific ground truth (like pathology), or detailed statistical metrics often associated with AI diagnostic devices. No specific acceptance criteria or performance numbers are quantified in the document, which is typical for a 510(k) summary demonstrating substantial equivalence primarily through technical compliance rather than novel clinical claims requiring extensive clinical trial data.

Summary

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K990560 p 1 q 2

510(k) Summary Life Imaging Systems L3Di

Submitter (Consultant) Name and Address

Morningstar Consulting Group, Inc. P. O. Box 219 Indian Hills, CO 80454

Submitter (Consultant) Contact Person

Kevin Morningstar. Senior Consultant phone (303) 697-8198 fax: (303) 697-7907

Manufacturer Name and Address

Life Imaging Systems, Inc. Suite 300, 195 Dufferin Avenue London, Ontario, Canada N6A 1K7

Manufacturer Contact Person

Tom Holbrook, Quality and Regulatory Affairs Manager phone (519) 679-4319 ext. 217 fax (519) 679-4320

Common, Classification & Proprietary Names

Common Name: Classification Name: Proprietary Name:

Digital Ultrasound Image Analysis System System, Image Processing Life Imaging Systems L3Di

Predicate Device

Life Imaging Systems LIS 6000A K961403

Device Description

The Life Imaging Systems L3Di is a high performance computer system based on Apple Computer and Windows NT standards. It incorporates a commercially

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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.

8242

K990560

The device records ultrasound transducer spatial position during use, either with transducer positioner assemblies or with a 6-degree of freedom coordinate tracking system.

Intended Use

The Life Imaging Systems L3Di 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 radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.

Technological Characteristics Comparison

The LIS L3Di is nearly identical in performance and intended use to the LIS 6000A. Both systems are based on Apple Computer architecture, with proprietary software added for ultrasound image acquisition, 3D reconstruction, analysis, archival and retrieval. Both systems are used in the same clinical setting. Both systems work with any existing diagnostic ultrasound imaging system.

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/2/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one in front of the other.

MAY 20 1999

Life Imaging Systems. Inc. c/o Kevin Morningstar Morningstar Consulting Group P.O. Box 218 Indian Hills, Colorado 80454

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K990560 Life Imaging Systems L3 Di Digital Ultrasound Image Analysis System Dated: February 15, 1999 Received: February 22, 1999 Regulatory Class: II 21 CFR 892 1560/Procode: 90 IYO 21 CFR 892.1550/Procode: 90 IYN

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 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 indude 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 requlation (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

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K990560

510(k) Number (if known):

Device Name: Life Imaging Systems L3Di

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymour

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

Prescription Use
(Per 21 CFR 801.109) √

Over-The-Counter Use

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.