DIAGNOSOFT HARP 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

DIAGNOSOFT HARP is a stand-alone software package, designed for the Microsoft Windows operating system, providing the capability to import, display, and analyze magnetic resonance images of the heart. HARP imports DICOM images containing anatomical MRI, tagged MRI, perfusion MRI, or delayed enhancement MRI and is independent of the MR scanner manufacturer. HARP is intended to support clinicians in the diagnosis of heart disease.

AI/ML Overview

The provided 510(k) summary for KOL 1368, Diagnosoft HARP, is lacking sufficient detail to fully answer all aspects of your request regarding acceptance criteria and performance study specifics.

The document states: "A large body of literature exists describing the performance of HARP methods. Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications." However, it does not provide the acceptance criteria used in these tests nor report the results of these specific tests.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document only states that "Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications." However, the specific "performance specifications" (i.e., acceptance criteria) are not defined, nor are the quantitative results of these tests provided.	Not explicitly reported in a quantitative manner. The document asserts that the device fulfills performance specifications but does not provide specific metrics or results from the verification and validation tests performed by Diagnosoft.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. It is not mentioned whether the data was from a specific country, or if it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: No, it was not done. The comparison provided (Table 2) is a side-by-side comparison of features between Diagnosoft HARP and the predicate device (Siemens Cardiac Tagging) rather than a comparative effectiveness study involving human readers. The document does not describe any study assessing the improvement of human readers with or without AI assistance.

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

Standalone Performance Study: Implied, but details are missing. The document states, "A large body of literature exists describing the performance of HARP methods. Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications." This suggests standalone tests were performed, but the specific results, methodology, and acceptance criteria are not provided. The HARP device itself is described as "a stand-alone software package," meaning its core function is algorithm-driven analysis.

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

Type of Ground Truth: Not specified.

8. The sample size for the training set

Sample Size for Training Set: Not specified. The document mentions "A large body of literature exists describing the performance of HARP methods," which might imply that the underlying algorithms were trained on data from this literature, but specific training set details are absent.

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

Ground Truth for Training Set: Not specified.

Summary of Limitations in the Provided Document:

The provided 510(k) summary is designed to establish substantial equivalence based on intended use, indications for use, principles of operation, and technology, rather than a detailed performance study report. It relies on existing literature for the performance of the underlying methods ("HARP methods") and a general statement that "additional verification and validation tests were performed...to demonstrate that Diagnosoft HARP fulfills performance specifications."

For a comprehensive answer to your questions about acceptance criteria and study specifics, a more detailed performance study report would be required, which is not present in this 510(k) summary.

Summary

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Kol 1368

JUL 2 8 2006

510(k) Summary for the Diagnosoft HARP (per 21 CFR 807.92)

1. SPONSOR

Diagnosoft, Inc. 3461 Kenneth Dr Palo Alto, CA 94303 Telephone: 650-320-9397 Facsimile: 253-663-0205

Primary Contact: Amr A. Awadallah Secondary Contact: Jerry L. Prince

1. DATE PREPARED: February 1, 2006

3. DEVICE NAME

Proprietary Name: DIAGNOSOFT HARP Common/Usual Name: HARP Classification Name: System, Image Processing

4. PREDICATE DEVICES

"Cardiac Tagging Techniques/Magnetom Vision and Impact (MR accessory)," 510(k) Number K973799, Siemens Medical Solutions, USA, Inc. Decision (Substantially Equivalent) Date 01/02/1998.

ನೆ DEVICE DESCRIPTION

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6. INTENDED USE

DIAGNOSOFT HARP is a stand-alone software package which provides the capability to review, 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.

7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Diagnosoft claims substantial equivalence to the visual analysis of myocardial tagging based on similarities in intended use, indications for use, principles of operation, technology, and performance. A side-by-side comparison of Siemens myocardial tagging and Diagnosoft HARP is provided in Table 1 below.

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Vendor	Siemens	Diagnosoft
Product Name	Cardiac TaggingTechniquesK973799	HARP

Intended Use	Support diagnosis	Support diagnosis
Indications for Use	Measures heartmotion	Measures heartmotion
Reveals myocardial motion	Yes	Yes
Assists in characterization of kinetic,hypokinetic, akinetic, and diskineticmyocardial regions	Yes	Yes
Permits regional functional analysis	Yes	Yes
Quantitative parameters viewedgraphically	No	Yes
Reports containing visualization of imagesand quantitative parameters.	No	Yes

Table 2 Side-by-Side Comparison of Siemens Cardiac Tagging Visual Analysis and Diagnosoft HARP.

8. PERFORMANCE TESTING

A large body of literature exists describing the performance of HARP methods. Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 8 2006

Mr. Amr A. Awadallah President Diagnosoft. Inc. 3461 Kenneth Dr. PALO ALTO CA 94303

Re: K061368

Trade/Device Name: Diagnosoft Harp Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 15, 2006 Received: May 16, 2006

Dear Mr. Awadallah:

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 is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. In the center of the logo are the letters "FDA" in a stylized font. Below the letters are three stars arranged in a horizontal line. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

Protecting and Promoting Public Health

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Page 2 -

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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Bogdon

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

Enclosure

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510(k) Number (if known): ___ Not Yet Assigned Ko 6 1368

Device Name: DIAGNOSOFT HARP

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K0 61368
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Prescription Use	X	OR	Over-the-Counter Use
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(Per 21 CFR 801.109)Diagnosoft Inc., Traditional 510(k) DIAGNOSOFT HARP

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.