The EnSite Verismo™ Segmentation Tool (EnSite Verismo) (EV1000) is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity™ System.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for the EnSite Verismo Segmentation Software v.2.0, focusing on its substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in a clinical study report. Therefore, I cannot complete the table or answer most of the questions based on the provided text.

Specifically, the document states:

"Bench testing was performed to confirm that the changes met design requirements and did not affect the safe or effective use of the product."
"Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness."

This indicates that internal design requirements and performance testing were conducted, but the details of these are not disclosed in this summary.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

Acceptance Criteria	Reported Device Performance
Not provided. The document states "bench testing was performed to confirm that the changes met design requirements," but does not list these specific requirements or their associated performance metrics.	Not provided. The document states "performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness," but no specific performance data (e.g., accuracy, precision) is given.

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 for test set: Not provided.
Data provenance: Not provided.

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 provided. The document does not describe any human expert review or ground truth establishment relevant to an external test set. It mentions "user testing" but no details are given.

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

Not provided.

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

Was an MRMC study done? Not provided. The focus is on substantial equivalence to a predicate device, not on reader improvement.
Effect size: Not applicable/Not provided.

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

The document implies standalone performance was assessed as part of "bench testing" and "performance testing" to ensure it met design requirements and was substantially equivalent, but no specific standalone performance metrics are given.

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

Not provided.

8. The sample size for the training set

Not provided. The document doesn't explicitly mention training or validation sets, as its focus is on demonstrating substantial equivalence to a previous version through verification and validation activities.

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

Not provided.

Summary

{0}------------------------------------------------

Date Prepared: July 9, 2010

12 510(k) Summary for Public Disclosure

12.1 Submitter's Name/Contact Person

Kris Miller St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 USA Establishment Registration Number: 2184149.

12.2 Common or Usual Name

Segmentation Software

12.3 Proprietary Name

EnSite Verismo Segmentation Software v.2.0

12.4 Classification Name

LLZ, System, Image Processing, Radiological (21 CFR 892.2050) Class II.

12.5 Indications for Use

The EnSite Verismo Segmentation Tool (EV1000) is indicated for use in generating 3D models from CT, MR, or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.

12.6 Device Comparison to the Predicate Device

The EnSite Verismo Segmentation Tool v.2.0 has the same intended use and fundamental scientific technology as the predicate device EnSite Verismo Segmentation Tool v. 1.0 (K051840).

All technological characteristics of the EnSite Verismo Segmentation Tool v.2.0 are substantially equivalent to the predicate device EnSite Verismo Segmentation Tool v.1.0 (K051840).

12.7 Summary of Non-Clinical Testing

Bench testing was performed to confirm that the changes met design requirements and did not affect the safe or effective use of the product. The following non-clinical bench tests were performed: software verification testing, hazard mitigation testing, code review, user testing, instructions for use (IFU) testing and regression testing.

{1}------------------------------------------------

12.8 Summary of Design Control Activities

The development of the EnSite Verismo Segmentation Tool was performed in accordance with St. Jude Medical's Quality System requirements and in compliance with Quality System Regulations design controls requirements documented in 21 CFR 820.30.

12.9 Conclusion

The EnSite Verismo Segmentation Tool has the same indications for use, intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Verismo Segmentation Tool are substantially equivalent to the predicate device.

Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness.

Therefore, St. Jude Medical considers the EnSite Verismo Segmentation Tool to be substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes extending from its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

St. Jude Medical % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

SEP 2222010

Re: K101697

Trade/Device Name: EnSite Verismo Segmentation Tool v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 10, 2010 Received: September 13, 2010

Dear Mr. Job:

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

{3}------------------------------------------------

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.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Form

Device Name: EnSite Verismo Segmentation Tool v.2.0

SEP 22 2010

Indications for Use

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 In Vitro Diagnostic Devices (OIVD)

Division Side-Off

Division Sien-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K1816 97

Page 1 of __

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).