Intended for use by or on the order of a qualified physician for analysis of ultrasound imaging of the human heart. Cardiac (adult and pediatric) applications using B-mode (including harmonic) imaging are supported. The system provides image data analysis applications that supply information on cardiac structure and motion.

Device Description

The Echolnsight™ software system enables the production and visualization of 2D tissue motion measurements (including tissue velocities, strain rates) and cardiac structural measurement information derived from tracking speckle in tissue regions visualized in any Bmode (including harmonic) imagery loops as captured by most commercial ultrasound systems.

The Echolnsight™ software system has been designed to ingest and process ultrasound imagery stored in files with content organized and encoded in conformance to the following the following standards:

NEMA PS3 (3.3, 3.5, 3.6, 3.10): Digital Imaging and Communications in Medicine . (DICOM), 2008.
ISO/IEC 10918-1:1994-02: Information technology Digital compression and coding of . continuous-tone still images – Requirements and guidelines (JPEG standard), 1994.
ISO/IEC 15444-1:2004: Information technology JPEG 2000 image coding system: . Core coding system, 2004.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EchoInsight™ device. However, it does not contain the acceptance criteria or details of a study proving the device meets acceptance criteria. The document primarily focuses on:

Device Description: What EchoInsight™ does (processing 2D tissue motion measurements, including velocities, strain rates, and cardiac structural measurements from ultrasound B-mode imagery using speckle tracking).
Intended Use: For analysis of ultrasound imaging of the human heart (adult and pediatric), providing information on cardiac structure and motion.
Technological Comparison to Predicate Device: Stating substantial equivalence to the Siemens VVI product (K091286) based on similar speckle tracking techniques for tissue motion, strain, and strain rate, and similar visualization capabilities.
FDA Clearance Letter: Confirming the substantial equivalence determination.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, device performance, or study details, as these are not present in the provided text.

To illustrate what the requested information would look like if it were present, here's a hypothetical structure:

Hypothetical Acceptance Criteria and Study Details (Based on typical medical device submissions, NOT on the provided text):

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (e.g., Predicate Equivalence, Clinical Threshold)	Reported Device Performance	Outcome
Accuracy of Strain Measurement	Mean absolute difference (MAD) ≤ 5% compared to predicate device or gold standard.	MAD = 3.8% vs. predicate	Met
Precision of Velocity Measurement	Coefficient of Variation (CV) ≤ 10% for repeated measurements.	CV = 7.2%	Met
Processing Time	Mean processing time per image < 5 seconds.	Mean processing time = 3.5 seconds	Met
Inter-operator Variability (Qualitative Agreement)	Kappa statistic > 0.8 for visual assessment of global and regional cardiac function.	Kappa = 0.85	Met
Intra-operator Variability (Quantitative Reproducibility)	Intraclass Correlation Coefficient (ICC) > 0.9 for key cardiac parameters (e.g., Global Longitudinal Strain).	ICC = 0.92	Met

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

Sample Size: For quantitative accuracy/precision, 150 cardiac ultrasound studies from 100 distinct patients. For qualitative assessment, 200 distinct cardiac ultrasound studies.
Data Provenance: Retrospective, de-identified cardiac ultrasound studies collected from three university hospitals in the United States, Germany, and Japan.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

Number of Experts: 3 independent expert cardiologists.
Qualifications: Each expert had over 10 years of experience in echocardiography interpretation, board-certified in cardiology, and specialized in advanced cardiac imaging techniques including speckle tracking.

4. Adjudication Method for the Test Set

Adjudication Method: 2+1 (Two experts' consensus was taken as ground truth; if they disagreed, a third expert provided a tie-breaking decision. All three experts were blinded to the device's output during ground truth establishment).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? Yes.
Effect Size of Human Readers Improvement with AI vs. without AI assistance:
- ROC AUC Improvement: Average increase in Area Under the Receiver Operating Characteristic Curve (ROC AUC) of 0.08 (e.g., from 0.82 to 0.90) for diagnosing early-stage cardiomyopathy.
- Reading Time Reduction: Average reduction in reading time per case by 25% (e.g., from 120 seconds to 90 seconds).
- Diagnostic Accuracy Increase: Increase in diagnostic accuracy by 10% (e.g., from 80% to 90%) in identifying regional wall motion abnormalities.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes.
Performance Metrics:
- Sensitivity: 92% for detecting global longitudinal strain abnormalities.
- Specificity: 88% for detecting global longitudinal strain abnormalities.
- Accuracy: 90% for classifying normal vs. abnormal cardiac function based on strain.

7. Type of Ground Truth Used

Ground Truth Type: Expert consensus from the 3 cardiologists, validated against subsequent patient outcomes data (e.g., pathology reports, follow-up clinical events over 12 months for cases of suspected disease).

8. Sample Size for the Training Set

Training Set Sample Size: 15,000 cardiac ultrasound studies from 10,000 distinct patients.

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

Training Set Ground Truth: Established through a combination of:
- Automated extraction of quantitative parameters from existing clinical reports (e.g., ejection fraction, global longitudinal strain measured by predicate devices or manual methods).
- Annotation by a team of trained, certified echocardiography technicians and junior cardiologists under the supervision of senior cardiologists.
- Randomized review of 10% of annotations by a senior cardiologist to ensure quality and consistency.

Crucially, the K110447 document is a 510(k) summary focused on substantial equivalence to a predicate device, not on detailed performance studies against specific acceptance criteria for a novel algorithm. For such details, one would typically look at the full 510(k) submission, associated peer-reviewed publications, or the manufacturer's technical documentation if it were a newer device.

Summary

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K110447

FDA /ODE/ CDRH February 14, 2011

Page 13

510(k) Summary

MAY 2 7 2011

Echolnsight™

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

Submitted By:

Ultrasound Medical Devices, Inc., dba Epsilon Imaging, Inc. 3917 Research Park Drive, Suite B7 Ann Arbor, Michigan 48108

Contact Person:

Paul Kortesoja Director of Operations Phone: (734) 369-5102 Fax: (734) 369-5120

Date Prepared:

February 14, 2011

Proprietary Name:

EchoInsight™

Common/ Usual Name:

Image Processing System

Classification Name:

21 CFR §892.2050 Picture archiving and communications system Product Code LLZ-Image Processing System

Predicate Device:

syngo US Workplace, K091286 (VVI component of Clinical Application Package[CAP])

Device Description:

The Echolnsight™ software system enables the production and visualization of 2D tissue motion measurements (including tissue velocities, strain rates) and cardiac «tructural measurement information derived from tracking speckle in tissue regions visualized in any Bmode (including harmonic) imagery loops as captured by most commercial ultrasound systems.

NEMA PS3 (3.3, 3.5, 3.6, 3.10): Digital Imaging and Communications in Medicine . (DICOM), 2008.
ISO/IEC 10918-1:1994-02: Information technology Digital compression and coding of . continuous-tone still images – Requirements and guidelines (JPEG standard), 1994.
ISO/IEC 15444-1:2004: Information technology JPEG 2000 image coding system: . Core coding system, 2004.

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Intended Uses:

EchoInsight™ is intended for use by or on the order of a qualified physician for analysis of ultrasound imaging of the human heart. Cardiac (adult and pediatric) applications using B-mode (including harmonic) imaging are supported. The system provides image data analysis applications that supply information on cardiac structure and motion.

Technological Comparison to Predicate Devices:

EchoInsight™ is substantially equivalent to the Siemens VVI product already cleared for introduction into interstate commerce as part of K091286, syngo US Workplace. The new and predicate devices both provide methods for determination of tissue motion, strain, and strain rate for cardiac structures based on speckle tracking techniques. The new and predicate devices provide similar image and information visualization capabilities. Both utilize B-mode ultrasound imagery from other vendor as well as same vendor ultrasound scanning devices as input.

End of 510(k) Summary

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare. The caduceus is composed of three curved lines that resemble snakes intertwined around a staff.

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

Ultrasound Medical Devices, Inc. c/o Paul Kortesoja Director of Operations 3917 Research Park Drive, Suite B7 ANN ARBOR MI 48108

MAY 2 7 2011

Re: K110447

Trade Name: EchoInsight Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 3, 2011 Received: May 4, 2011

Dear Mr. Kortesoja:

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.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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FDA /ODE/ CDRH February 14, 2011

Indications for Use

510(k) Number (if known):

EchoInsight™ Device Name:

Indications for Use:

Prescription Use × (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)

Mane Slatte
(Division Sign-On)

Office of In antinatic De

K110447
§10K

Page _1_of _1

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).