Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.

Device Description

Corridor4DM is a comprehensive cardiac emission computed tomographic (ECT) application designed to review and quantitatively analyze cardiac ECT (SPECT and PET) nuclear medicine patient studies. The application provides tools for processing and displaying standard ungated and ECG gated cardiac ECT images on both a slice-by-slice basis and as a 3-dimensional surface rendered images in many user selectable formats. Additionally, it provides quantitative assessments of heart function by computing and displaying left ventricular chamber volumes, ejection fraction and transient ischemic dilation (TID) values and provides an assessment of the data set(s) in comparison to a similar patient population with a low likelihood of cardiac disease. The application provides a number of different single or multi-dimensional display(s) to allow the users to select those that best fit their needs. Cardiac CT interpretation and cardiac calcium quantification are optional features that are integrated into Corridor4DM.

AI/ML Overview

This 510(k) summary for the Corridor4DM device does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technology comparison, and general system performance, rather than providing specific performance metrics, acceptance criteria, or a detailed study design with statistical evidence.

However, I can extract the information that is present and highlight what is missing.

Missing Information Disclaimer

The provided 510(k) summary does not include:

A table of specific acceptance criteria.
Quantitative reported device performance metrics against those criteria.
Details on the sample size used for any test set or the data provenance.
The number or qualifications of experts used to establish ground truth for a test set.
Any adjudication method.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
Whether a standalone (algorithm only) performance study was done.
The type of ground truth used for a test set (e.g., pathology, outcomes data).
The sample size for a training set.
How ground truth for a training set was established.

Information Extracted from the Provided 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or reported device performance data against such criteria are provided in this 510(k) summary.

The comparison table provided focuses on features and functionalities to demonstrate substantial equivalence, not performance metrics.

Feature	Corridor4DM (Intended Performance/Functionality)	Predicate Device (3D-MSPECT)	Predicate Device (Siemens Calcium Scoring)
Computer based templating system	Yes (Present)	Yes	NA
Digital image retrieval of patient radiographs	Yes (Present)	Yes	NA
Patient Studies Type	ECT, PET, CT (Supported)	ECT, PET	N/A
Measurement Tools	Yes (Present)	Yes	NA
Overlay of prosthetic templates for proper selection by physician	Yes (Present)	Yes	NA
Generation of Parts List	Yes (Present)	Yes	NA
Patient files can be saved locally, on a network, or printed.	Yes (Present)	Yes	NA
Allows for assessment of wear.	Yes (Present)	Yes	NA
Identify and quantify CT data via imaging (Calcium Scoring feature)	Yes (Present)	No	Yes

Note: The "Reported Device Performance" in this context refers to the affirmation of the presence or absence of a feature, rather than quantitative performance metrics like sensitivity, specificity, accuracy, or statistical equivalency. The submission argues for substantial equivalence based on having similar functionalities as the predicate devices.

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

Not specified in the provided 510(k) summary. The document does not describe a clinical performance study with a specific test set. The comparison is based on functional equivalence to predicate devices.

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

Not applicable/specified. A formal test set with expert-established ground truth is not detailed in this 510(k) summary.

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

Not applicable/specified. An adjudication method for a test set is not described.

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

Not applicable/specified. This 510(k) summary does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is a "processing, quantification, and multidimensional review" application, not explicitly an AI-assisted diagnostic tool in the typical sense for MRMC studies as of this submission date (2008). The focus is on providing tools for quantification and review.

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

Not applicable/specified. No standalone performance study details are provided. The device is described as an application with processing, quantification, and review tools, implying human interaction.

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

Not applicable/specified. Since no specific performance study with a test set is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set

Not specified. The document does not describe an AI/machine learning model development process with a training set.

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

Not applicable/specified. As no training set is described, the method for establishing its ground truth is also not.

Summary

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K080575

510k Summary

A) Submitted by: INVIA, LCC 3025 Boardwalk, Suite 200 Ann Arbor, MI 48108 Registration: 9069896

MAY 1 3 2008

Contact: MEDIcept 200 Homer Ave Ashland, MA 01721 F. David Rothkopf 508-231-8842 x20 508-231-8861 Fax

Corridor4DM B) Device Name: Common Name: System, Emission Computed Tomography & System, X-Ray Computed Tomography

Device Class:	21 CFR 892.1200
	21 CFR 892.1750 CLASS I

KPS, JAK Product Code

C) Predicate:

Reagents of the University of Michigan 3D-MSPECT system (K001026) Siemens, Calcium Scoring Software Package (K990426)

D) Device Description:

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E) Intended Use:

Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.

F) Comparison to Predicate Device(s):

The Corridor 4DM has the same intended use, target population, and clinical setting as other SPECT software including the predicate devices. It uses the same technology as the predicate devices (3D-MSPECT system (K001026) and Calcium Scoring Software Package (K990426).

Features	Corridor4DM	3D-MSPECT	Siemens CalciumScoring SoftwarePackage
Computer basedtemplating system	Yes	Yes	NA
Digital image retrievalof patient radiographs	Yes	Yes	NA
Patient Studies Type	ECT, PET, CT	ECT, PET	N/A
Measurement Tools	Yes	Yes	NA
Overlay of prosthetictemplates for properselection by physician	Yes	Yes	NA
Generation of Parts List	Yes	Yes	NA
Patient files can besaved locally, on anetwork, or printed.	Yes	Yes	NA
Allows for assessmentof wear.	Yes	Yes	NA
Identify and quantifyCT data via imaging	Yes	No	Yes

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Corridor4DM 510(k) Premarket-Notification Submission

G) Guidance Document

Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final, FDA December 3, 1998

H) Conclusion:

Invia, LLC believes that the Corridor4DM is substantially equivalent to the predicate devices based on intended usage, technology comparison and system performance.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2008

Invia Mr. F. David Rothkopf President MEDIcept, Inc. 200 Homer Ave ASHLAND MA 01721

Re: K080575

Trade/Device Name: Corridor4DM Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK, and LLZ Dated: February 20, 2008 Received: February 29, 2008

Dear Mr. Rothkopf:

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 for assession 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 (PMA), 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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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

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Indications for Use Form

510(k) Number (if known): K080575

Device Name: Corridor4DM

Indications for Use:

Prescription Use X OR Over-the-Counter Use _____21 CFR 801.109

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hory M. Khan

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

February 20, 2008

Corridor4DM

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.