The Diagnosoft, Inc. HARP 2.06 is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization.

Tagged MR images can be imported, displayed and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart.

A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.

Device Description

The Diagnosoft, Inc. HARP 2.06 is intended for the quantification of regional and global cardiac function from magnetic resonance images. It includes a user friendly implementation of the HARP methods for fast and reproducible measuring of myocardial motion and strain in the heart. With a friendly graphic user interface, users are able to analyze tagged MR images in minutes and produce many measurements including strain, torsion, and regional wall thickening.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Diagnosoft, Inc. HARP 2.06 device:

It is important to note that the provided text is a 510(k) summary and FDA clearance letter, which often do not contain the detailed performance study results that would be found in a full study report or scientific publication. Therefore, some of the requested information, particularly specific performance metrics and sample sizes for the test set, adjudication methods, and detailed ground truth establishment, is not explicitly stated in this document.

Acceptance Criteria and Reported Device Performance

The document states that "Testing of the modified Diangosoft, Inc. HARP 2.06 has demonstrated that the device fulfills prospective defined performance criteria and that the modified device meets the user needs." However, the document does not provide specific quantitative acceptance criteria or a table of reported device performance values. It broadly states that the device's "performance specifications for the software characteristics performed by the HARP 2.06 are substantially equivalent to those of the HARP 1.1.0."

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided document. The document states that the device fulfills "prospective defined performance criteria" and "meets the user needs."	Not explicitly stated in the provided document. The document indicates that the performance is "substantially equivalent to those of the HARP 1.1.0."

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. It does not mention the country of origin of the data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided document.
Adjudication method for the test set:
- Not specified in the provided document.
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 in the provided document. The device is a "stand-alone software package" intended for "quantification of regional and global cardiac function," and the results "are interpreted by the physician." The study focuses on demonstrating substantial equivalence to its predicate device rather than human-AI collaboration.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance testing described is for the device as a "stand-alone software package." The document states, "Testing of the modified Diangosoft, Inc. HARP 2.06 has demonstrated that the device fulfills prospective defined performance criteria." This implies a standalone evaluation of the algorithm's performance in generating measurements.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Given the context of "quantification of regional and global cardiac function," the ground truth for strain, displacement, and twist measurements would typically involve established, perhaps manually derived, measurements from the same tagged MR images, or potentially phantom studies with known motion. However, the document does not specify the exact method for establishing this ground truth.
The sample size for the training set:
- Not specified in the provided document. Training set information is typically not included in a 510(k) summary for this type of device, especially when it's an upgrade that focuses on demonstrating equivalence.
How the ground truth for the training set was established:
- Not specified in the provided document.

Summary of what is present and what is missing:

The document clearly states that performance testing was conducted and that the device met pre-defined criteria and user needs, and is substantially equivalent to its predicate.
It functions as a standalone software for quantification.
Crucially, the document lacks specific quantitative details about the performance criteria, the results of the performance testing, the sample sizes of the test and training sets, the provenance of the data, the exact methodology for establishing ground truth, the number/qualifications of experts, or any MRMC studies. This level of detail is often summarized or omitted in the publicly available 510(k) summary but would be present in the full submission to the FDA.

Summary

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K100352

Diagnosoft, Inc. HARP 2.06 510(k) Summary (per 21 CFR 807.92(c))

MAR 1 1 2010

1. SPONSOR/MANUFACTURER

Diagnosoft, Inc. 6501 Weston Parkway Suite 125 Cary, NC 27513 Primary Contact:

Linda Horne

Date Prepared: February 11, 2010

2. DEVICE NAME

Proprietary Name: Diagnosoft HARP 2.06 Common/Usual Name: HARP Classification Name: System, Image Processing, MRI Accessory

3. PREDICATE DEVICE

Predicate Device: Diagnosoft, Inc. HARP 1.1.0, K061368

4. DEVICE DESCRIPTION

5. INDICATION FOR USE

Diagnosoft, Special 510(k): Device Modification HARP 2.06

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three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization.

Tagged MR images can be imported, displayed, and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The modified Diagnosoft, Inc. HARP 2.06 is an upgrade of the predicate Diagnosoft, Inc. HARP 1.1.0. The modified Diagnosoft, Inc. HARP 2.06 is substantially equivalent to the predicate Diagnosoft, Inc. HARP 1.1.0 based on intended use, indications for use, operational characteristics, and fundamental technology characteristics. The performance specifications for the software characteristics performed by the HARP 2.06 are substantially equivalent to those of the HARP 1.1.0.

7. PERFORMANCE TESTING

Testing of the modified Diangosoft, Inc. HARP 2.06 has demonstrated that the device fulfills prospective defined performance criteria and that the modified device meets the user needs.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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

Diagnosoft, Inc. % Mr.. Jeffrey Roberts Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

MAR 1 1 2010

Re: K100352

Trade/Device Name: Diagnosoft, Inc. HARP 2.06 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 11, 2010 Received: February 12, 2010

Dear Mr. Roberts:

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 includions 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, Drig 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, inting 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 frither 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 manufact 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,

Amih Jt. R

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

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Indications for Use

510(k) Number (if known);

Device Name:

Diagnosoft, Inc. HARP 2.06

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

D.V.R.
(Division Sign Off)

Page 1 of 1

Division Sign-Off Division of Radiological De Office of In Vitro Diagnostic Device Evalua

510K. K100352

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.