The 3TP Software Option is intended to be used as a post processing software package designed to provide a reliable means for visualizing the presence and pattern of contrast induced enhancement on MR datasets. 3TP supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained physician the information provided by the 3TP Software Option could yield information that may assist in the interpretation of dynamic contrast enhanced studies.

Device Description

The 3TP Software Option is a post processing software module. The 3TP Software Option supports the evaluation of dynamic MR data gathered after the injection of a bolus of a contrast agent. Multi-sliced MR datasets with specified time intervals are used for input. The purpose is to provide a new composite "3TP Image" that provides a trained physician with information useful for diagnostic purposes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3TP Software Option:

It's important to note that this document is a 510(k) summary from 2003, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing extensive details on novel performance studies with statistical significance. As such, information on some of your requested points is either very limited or entirely absent.

Summary of Acceptance Criteria and Device Performance based on the document:

Acceptance Criteria	Reported Device Performance
Successfully complete integration testing and verification.	Stated that this will be completed prior to beta validation.
Successfully complete software beta testing.	Stated that this will be successfully completed validating the 3TP Software Option prior to market release.

Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
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. The document primarily discusses internal software testing (integration and beta testing) rather than clinical performance testing with expert readers and ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Given the nature of the described "performance testing" (integration and beta of software), formal adjudication by multiple experts for a clinical test set is not mentioned.
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 described. The document states: "In the hands of a trained physician the information provided by the 3TP Software Option could yield information that may assist in the interpretation of dynamic contrast enhanced studies." This implies assistance, but no formal comparative effectiveness study is presented.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Performance Testing" section describes integration testing and beta testing. These are internal software tests to ensure functionality and stability, not standalone clinical performance evaluation against a medical ground truth. The device is explicitly intended to provide "information that may assist in the interpretation" by a "trained physician," indicating a human-in-the-loop design.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "Performance Testing" described (integration and beta testing), the "ground truth" would likely be the expected software output and functionality, verified by engineers/testers against software specifications. There is no mention of medical ground truth (e.g., pathology, outcomes, expert consensus) being used for performance evaluation in a clinical context.
The sample size for the training set:
- This document does not describe the development or training of an AI/ML model in the modern sense. It describes a "post processing software package." Therefore, there is no mention of a "training set" as it would apply to machine learning.
How the ground truth for the training set was established:
- As there's no mention of a training set for an AI/ML model, this information is not applicable.

Explanation and Context:

This 510(k) summary (from 2003) predates the widespread adoption of AI/ML in medical devices and the rigorous performance study requirements now common for such devices. The "performance testing" described ("integration testing and verification" and "software beta testing") are standard software development lifecycle activities focused on ensuring the software correctly performs its intended functions according to specifications, rather than clinical performance studies measuring diagnostic accuracy or reader improvement.

The primary argument for safety and effectiveness relies on substantial equivalence to predicate devices (GE Advantage Windows With Functool Option, GE Prostate Spectroscopy and Imaging Exam (PROSE), Philips EasyVision Quantitative Analysis Option). The 3TP Software Option "provides a post-processing means for analyzing changes in signal intensity of a contrast agent as reflected in MR images," similar to these predicate devices. The claim is that it "does not result in any additional hazards" and "does not include any new indications for use nor does the use of this device result in any new potential hazards" compared to the predicate devices. This type of submission relies on the established safety and effectiveness of the existing predicate devices, rather than comprehensive de novo clinical performance studies.

Summary

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ATTACHMENT 7

JUN 2 3 2003

Summary of Information Respecting Safety And Effectiveness

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

Contact:	Vincent J. McGill
Phone:	(212) 779-9910
Fax:	(212) 779-9928
Product:	3TP Software OptionImaging Processing Software for N

MR Devices Manufactured by: 3TP LLC Distributed by: 3TP LLC

1) Indications for Use

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The 3TP Software Option is intended to be used as a post processing software package designed to provide a reliable means for visualizing the presence and pattern of contrast induced enhancement on MR datasets. 3TP supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained physician the information provided by the 3TP Software Option could vield information that may assist in the interpretation of dynamic contrast enhanced studies.

Device Description 2)

Marketing History 3)

The software has not yet been marketed.

Predicate Devices 4)

GE Advantage Windows With Functool Option (K960265) GE Medical Systems 300 N. Grandview Blvd. Waukesha, WI 53186

GE Prostate Spectroscopy and Imaging Exam (PROSE) (K011604) GE Medical Systems 300 N. Grandview Blvd. Waukesha, WI 53186

Philips EasyVision (Quantitative Analysis Option) (K971965) Philips Medical Systems 710 Bridgeport Ave Shelton, Ct 06484

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Similar to each of the named predicate devices the 3TP Software Option provides a postprocessing means for analyzing changes in signal intensity of a contrast agent as reflected in MR images. The use of the 3TP Software Option does not result in any additional hazards when compared to the post-processing software packages (Functyool, PROSE and Philips Easy Vision) currently being marketed by GE Medical Systems and Philips Medical Systems. The 3TP Software Option does not include any new indications for use nor does the use of this device result in any new potential hazards.

5. Performance Testing

The 3TP Software Option will successfully complete integration testing and verification prior to beta validation and the software beta testing will be successfully completed validating the 3TP Software Option prior to market release.

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Image /page/2/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2003

3TP LLC % Mr. Vincent J. McGill Eaton & Van Winkle, LLP 3 Park Avenue NEW YORK NY 10016

Re: K031350

Trade/Device Name: 3TP Software Option Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: April 28, 2003 Received: April 29, 2003

Dear Mr. McGill:

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. Iisting 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 (PMA), it may be subject to 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.

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.

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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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

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

Enclosure

Page 2

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1350 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David h. Symm

Division Sign-Off ivision of Reproductive, Abdomina nd Radiological Devices 510(k) Number

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.