LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. LMS-Liver can segment hepatic lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics such as size, volume and intensity.

LMS-Liver can match and compare lesions present in two different datasets of the same patient acquired at different dates and compute their difference of size and volume.

AI/ML Overview

The provided 510(k) summary for LMS-Liver does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets them in the way typically expected for a performance study. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on functional characteristics and intended use.

Here's an analysis of the provided information relative to your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported performance metrics (e.g., 90% sensitivity achieved) are provided in the document. The submission relies on a qualitative comparison to predicate devices, stating that LMS-Liver is "equivalent in function to existing legally marketed devices."

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Functionality	Expected to perform image visualization, lesion analysis, 3D registration, follow-up comparison, and reporting.	Stated to perform these functions, similar to predicate devices.
Safety	Residual risks acceptable.	Concluded that residual risks are acceptable.
Effectiveness (Implied by equivalence)	Equivalent in function and intended use to predicate devices.	Stated to be equivalent in function to existing legally marketed devices.

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

The document does not describe a formal performance study with a test set of images. There is no mention of a specific sample size, data provenance, or whether the data was retrospective or prospective.

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)

Since no formal test set or performance evaluation is described, there is no information about experts used to establish ground truth.

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

Without a described test set or performance study, no adjudication method is mentioned.

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

The document does not describe an MRMC comparative effectiveness study. The focus is on the device's standalone functionality and its equivalence to other software, not on how it improves human reader performance.

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

While the device's functionality is described for assisting radiologists, the submission primarily focuses on the device's capabilities in isolation ("LMS-Liver can segment hepatic lesions... computes its characteristics... match and compare lesions..."). This implies a standalone evaluation of its features and functions, but without specific performance metrics. The comparison chart with predicate devices (Siemens Syngo TrueD software and Cedara I-Response/PET/CT) focuses on feature parity.

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

As no explicit performance study or test set is described, there is no mention of the type of ground truth used.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size. This is common for submissions focused on feature equivalence rather than AI/ML model performance, especially in 2007.

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

Since no training set is mentioned, there is no information on how its ground truth would have been established.

Summary of the Study (as presented in the 510(k)):

The provided 510(k) summary does not describe a conventional clinical or performance study with acceptance criteria and measured device performance in the modern sense of AI/ML device evaluations. Instead, the "study" proving the device meets acceptance criteria** is implicitly the comparison to predicate devices and a hazard analysis.**

Acceptance Criteria (Implicit): That the device performs functions similar to the legally marketed predicate devices (Siemens Syngo TrueD software and Cedara I-Response; Cedara PET/CT) and does not introduce new safety risks.
Study: The submission relies on a substantial equivalence comparison chart (section titled "Substantial Equivalence Comparison Chart") that lists functional similarities between LMS-Liver and the predicate devices. It also states that a "comprehensive hazard analysis" was conducted, concluding that "residual risks are acceptable." This hazard analysis serves as the safety "study."

In conclusion, the document demonstrates substantial equivalence by outlining the device's features and comparing them to those of established predicate devices, and by performing a safety assessment, rather than by presenting a detailed performance study with quantitative acceptance criteria and measured results on a specific dataset. This approach was more common in 510(k) submissions of that era for image analysis software.

Summary

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JUN - 8 2007

510(k) Summary

Submitter's Information

Submitted by MEDIAN Technologies Le Solaris 120 rue Albert Caquot 06560 Sophia Antipolis France Fax: +33 93 333 777 Contact: Fredrik Brag, CEO Fredrik.brag@mediantechnologies.com Tel: +33 93 333 777

Questions or requests for further information should be addressed to: Michael Auffret, VP Product Management Michael.auffret@mediantechnologies.com Tel: +33 4 92 90 65 84

Date summary was prepared: May 14, 2007

Name of Device

Proprietary name: LMS-Liver Common name: Image visualization and analysis software package Classification Name: Class II 21 CFR 892.2050 LLZ

Predicate Devices

Manufacturer:	SIEMENS	CEDARA
CommonName:	Accessory to Computed TomographyX-ray System /II/ 90	Accessory to Computed TomographyX-ray System /II/ 90
Trade Name:	Syngo TrueD software	Cedara I-Response; Cedara PET/CT
510(k)Number:	K061671	K053301

Device Description

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LMS-Liver can match and compare lesions present in two different datasets of the same patient acquired at different dates and compute their difference of size and volume.

Indication for use

LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images.

LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.

Substantial Equivalence Comparison Chart

Manufacturer	Siemens	Cedara	MEDIAN
Product Name	SyngoTrueDsoftware	Cedara I-Response;CedaraPET/CT	LMS-Liver
510(k)	K061671	K053301
Software only solution	√	√	√
Windows XP operating system	√	√	√
CT scans as Input	√	√	√
Support the oncological workflow byhelping the user assess and documentmorphological changes in therapyfollow-up examinations	√	√	√
Compare medical imaging data fromdifferent time points	√	√	√
Landmark matching and visualalignment	√	√	√
Lesion comparison over time	√	√	√
Report Generator	√	√	√

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Safety

A comprehensive hazard analysis was carried out on MEDIAN Technologies' LMS-Liver software. It concluded that residual risks are acceptable when weighed against the intended benefits of the system.

Conclusion

LMS-Liver software does not raise new safety risks and is equivalent in function to existing legally marketed devices. LMS-Liver software is therefore substantially equivalent with respect to safety and effectiveness to the predicate devices.

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Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The central graphic features a stylized depiction of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or feathers. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services in the United States.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Median Technologies % Mr. Chas Burr President Chas Burr Q/R Services, Inc. 11 Mystic Avenue WINCHESTER MA 01890-2920

Re: K071241

Trade/Device Name: LMS-Liver Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 30, 2007 Received: May 3, 2007

Dear Mr. Burr:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/9 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" at the top. Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The logo is circular and contains the letters "FDA" in a stylized design.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): _K071241

Device Name: LMS-Liver

Indications for Use:

LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images.

LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut lemer no

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

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).