EchoSoft™ is a software calculation package that is used with diagnostic ultrasound images to provide mechanical information about tendon-like tissues of interest that may be used by a physician, along with other medical data, to assist in clinical diagnosis. The software is intended to be used by trained professionals only.

Device Description

The Echometrix, LLC software, EchoSoft, is an image processing algorithm that, when used with diagnostic ultrasound images, provides qualitative information about the mechanical characteristics of the deforming material by tracking motion, deformation, and ultrasonic echo magnitude change within a given region. This technology can be used by a physician to gather information about the mechanical and functional properties of soft tissues which, in conjunction with standard medical data, can be used to assist in clinical diagnosis.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, comprehensive device performance data, detailed study methodologies, or comparative effectiveness studies for EchoSoft™. However, based on the information provided, I can construct an answer with the available details and identify where information is missing.

Here's a breakdown of the acceptance criteria and study information, as much as can be gleaned from the text:

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

The document does not explicitly list quantitative acceptance criteria in a dedicated table format or specific performance metrics with target values. It broadly states that the software was evaluated to "verify the ability of the algorithm to distinguish between materials with different mechanical properties" and to "verify performance parameters such as resolution, sensitivity and precision." No actual numbers for these parameters are provided.

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

Sample Size (Test Set): The exact sample size for the test set is not specified. The document mentions "multiple studies" including "laboratory measurements on phantoms," "several studies conducted on bovine tendons," and "sample clinical images." The number of phantoms, bovine tendons, or clinical images is not quantified.
Data Provenance:
- Phantoms: Laboratory measurements.
- Bovine Tendons: Implies laboratory or research setting, likely not patient data.
- Clinical Images: Described as "sample clinical images" with "previously diagnosed injuries." There is no indication of the country of origin.
- Retrospective/Prospective: Not explicitly stated for any of the data types. "Previously diagnosed injuries" for clinical images suggests a retrospective collection, but this is not confirmed.

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)

This information is not provided in the document.

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

This information is not provided in the document. Given the nature of the studies (phantom, bovine tissue, and "sample clinical images"), formal expert adjudication methods commonly seen in human-in-the-loop clinical trials are unlikely to have been detailed in this regulatory submission.

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

There is no indication that an MRMC comparative effectiveness study involving human readers with and without AI assistance was performed or reported in this submission. The device is a software calculation package designed to provide "mechanical information," not primarily to improve human reader diagnostic accuracy in a comparative setting described for MRMC studies. The software is intended to "assist in clinical diagnosis," implying its output is used by a physician in conjunction with other data, but its effect on reader performance is not quantified.

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

Yes, the studies described are characteristic of standalone algorithm testing.

"The EchoSoft 100 software was evaluated with multiple studies to verify the ability of the algorithm to distinguish between materials with different mechanical properties."
"The studies consisted of laboratory measurements on phantoms containing materials with varying elastic properties to verify performance parameters such as resolution, sensitivity and precision."
"Several studies were conducted on bovine tendons to demonstrate performance on tissue samples with known defects."
"Sample clinical images were also provided to demonstrate performance of the software on tendons with previously diagnosed injuries."

These describe direct evaluations of the algorithm's output against known properties or diagnoses, without explicit human reader interaction within the performance metrics.

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

The ground truth used varied depending on the type of study:

Phantoms: "Materials with varying elastic properties." The ground truth would be the known mechanical properties (e.g., stiffness/elasticity) of these engineered phantom materials.
Bovine Tendons: "Tissue samples with known defects." The ground truth would be the known presence or absence and characteristics of these defects, likely established through direct inspection, mechanical testing, or other means.
Clinical Images: "Tendons with previously diagnosed injuries." The ground truth was the existing clinical diagnosis for these injuries. The method of establishing this clinical diagnosis (e.g., expert clinical assessment, MRI, surgery, pathology) is not specified.

8. The sample size for the training set

This information is not provided in the document. The submission focuses on the evaluation (test) studies, with no mention of the training data used to develop the algorithm.

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

This information is not provided in the document, as the training set itself is not discussed.

Summary

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SEP 2 1 BOR

Echometrix, LLC 437 S. Yellowstone Drive Madison, WI 53719 USA

610 K SUMMARY OF SAFETY AND EFFECTIVENESS

o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

o Identification of Submitter

Echometrix, LLC 437 S. Yellowstone Drive, Suite 210 Madison, WI 53719 Contact: Larry A. Kroger, Ph.D., Regulatory Consultant Ph. 262-549-6646 Revised July 12, 2012

Identification of the Product

Proprietary name: EchoSoft™ Classification name: Picture archiving and communication system Product Code: LLZ

0 Marketed Devices_

EchoSoft™ is a new software package which utilizes an acoustoelastography technique with diagnostic ultrasound images to analyze the mechanical properties of tendon and tendon-like tissues. It performs functions similar to software currently available on the following marketed diagnostic ultrasound devices:

Philips iU22 Diagnostic Ultrasound System intended for diagnostic A ultrasound imaging in B-mode (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Harmonics (Tissue and Contrast) and Elastography modes, PMN# K093563, classification number and name 21 CFR 892.1550 Ultrasonic pulsed doppler imaging system, product code IYN.
Toshiba SSA-790A Aplio XG v4.0R001 Diagnostic Ultrasound System intended for diagnostic imaging in B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Dynamic Flow, 3D Imaging, and indicated for determining the relative elasticity of a lesion, PMN# K092179, classification number and name 21 CFR 892.1550 Ultrasonic
pulsed doppler imaging system, product code IYN.
A Hitachi Hi VISION Preirus Diagnostic Ultrasound System intended for diagnostic imaging in B mode, M mode, PW mode (Pulsed

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Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography, PMN# K093466, classification number and name 21 CFR 892.1560 Ultrasonic pulsed echo imaging system, product code IYO.

0 Device Description

Intended Uses

EchoSoft™ is a software calculation package that is used with diagnostic ultrasound images to provide mechanical information about tendon and tendon-like tissues (such as ligaments) that may be used by a physician, along with other medical data, to assist in clinical diagnosis of various types of physical conditions or injuries.

Comparison with Predicate

EchoSoft™ is a software calculation package that will be marketed as stand-alone software. Ultrasound images are accessed and incorporated into the analysis package via standard communication protocols such as DICOM. For the predicate devices similar software capabilities are incorporated into the system and are marketed as part of a total diagnostic ultrasound system.

0 Summary of Studies

The EchoSoft 100 software was evaluated with multiple studies to verify the ability of the algorithm to distinguish between materials with different mechanical properties. The studies consisted of laboratory measurements on phantoms containing materials with varying elastic properties to verify performance parameters such as resolution, sensitivity and precision. Several studies were conducted on bovine tendons to demonstrate performance on tissue samples with known defects. Sample clinical images were also provided to demonstrate performance of the software on tendons with previously diagnosed injuries. Some of the studies were conducted on ultrasound systems from different

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manufacturers to verify reproducibility of the results. The ultrasound systems used in the studies were produced by GE (model Logiqe), Siemens (model S2000), and Terason (model t3000).

Conclusions

It is the opinion of Echometrix that EchoSoft™ software is substantially equivalent to the elastography options available for the predicate devices. EchoSoft™ does not include any new indications for use with regards to evaluating the mechanical properties of tendon and tendon-like tissues. nor does use of this software result in any new potential hazards.

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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 a stylized symbol of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

SEP 21 2012

Echometrix, LLC % Mr. Larry A. Kroger Regulatory Consultant 2210 Woodhiil Way WAUKESHA WI 53189

Re: K111142

Trade/Device Name: EchoSoft™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 30, 2012 Received: July 31, 2012

Dear Mr. Kroger:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Pivision of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K111142

Device Name: EchoSoft™

Indications For Use: EchoSoft™ is a software calculation package that is used with diagnostic ultrasound images to provide mechanical information about tendon-like tissues of interest that may be used by a physician, along with other medical data, to assist in clinical diagnosis. The software is intended to be used by trained professionals only.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aluph D. O'thim.

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K///42

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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).