Volumina enables the display of 3D (MIP/MPR) visualization of CT, PET, and MR studies or other DICOM compliant images. Typical users are radiologists, technologists and clinicians. Not for mammographic purposes.

Device Description

Volumina is a Class II software application comprised of a client module and a server module. Volumina is intended to provide a diagnostic quality image to a qualified health care professional to visualize multimodal medical image data.

AI/ML Overview

The provided document is a 510(k) summary for the Volumina device. It details the device's purpose, predicate devices, and the general testing methodology. However, it does not contain specific acceptance criteria or a detailed study proving the device meets them in the format requested.

The document states:

"Verification and Validation was conducted according to written protocols and the test outcomes were documented with test reports including pass/fail determination."
"Validation was undertaken to demonstrate that the Volumina Client and Server Modules together consistently fulfill the requirements within the intended use operates as intended under actual operating conditions by accepting the required parameters as input and by returning the expected output, and that the user interface provides a display that is consistent with the data that has been given."
"A tabulation of Test Procedures, expected Results and Outcomes and are included in Appendix 16-C Traceability Matrix"

This implies that such information exists in the full 510(k) submission, likely in "Appendix 16-C Traceability Matrix" and "Section 16. Software, Item 7. Verification & Validation Testing," but it is not present in the provided excerpt.

Therefore, I cannot populate the table or answer most of the specific questions.

Here's what can be inferred or stated based on the provided text:

Acceptance Criteria & Reported Performance: Not explicitly stated in the provided text. The document refers to "written protocols" and "pass/fail determination" in a "Traceability Matrix" (Appendix 16-C) which is not included.
Study Details: The document mentions "Verification and Validation" testing, but it does not describe a clinical study or a comparative performance study in the context of diagnostic accuracy, which is typically what acceptance criteria and studies are designed to demonstrate for AI/medical imaging devices. Volumina appears to be a 3D visualization and image processing system, not an AI-driven diagnostic algorithm.

Information that can be extracted or inferred:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance
Not provided in the document	Not provided in the document
(e.g., Image Fidelity Accuracy)	(e.g., Displayed images match source data within X% tolerance)
(e.g., Processing Time)	(e.g., 3D reconstruction within Y seconds for Z volume size)
(e.g., Software Functionality)	(e.g., All specified features operate as intended)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: "The test data was retrieved from a PACS database containing actual patient Raw Data. Some synthetic data of known dimensions and values was also used for verification and validation." The country of origin is not specified, but the device is for FDA approval in the USA. Given it's a visualization tool rather than a diagnostic algorithm, the specific patient data provenance (country, retrospective/prospective) might be less critical than for an AI diagnostic device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given the device is for image display and visualization (MIP/MPR), the "ground truth" might pertain more to technical accuracy of the display and processing rather than diagnostic accuracy established by expert consensus on specific diseases.
Adjudication method for the test set:
- Not provided.
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, a MRMC comparative effectiveness study is not mentioned. The device's primary function is 3D visualization, not AI-assisted diagnosis or enhancement of human reader performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document describes "Validation was undertaken to demonstrate that the Volumina Client and Server Modules together consistently fulfill the requirements within the intended use operates as intended under actual operating conditions by accepting the required parameters as input and by returning the expected output, and that the user interface provides a display that is consistent with the data that has been given." This suggests a standalone functional verification focused on the software's ability to process and display images accurately. It is not an "algorithm-only" performance in the sense of a standalone diagnostic algorithm.
The type of ground truth used:
- For the "actual patient Raw Data," the "ground truth" would likely be the inherent data integrity and accuracy as captured by the original imaging modalities (CT, PET, MR). For "synthetic data," the ground truth would be the known dimensions and values of the synthetic data itself, allowing for direct comparison to the device's output.
The sample size for the training set:
- Not applicable/Not provided. The document does not describe an AI/machine learning component that would require a "training set." This device is a software application for image processing and display.
How the ground truth for the training set was established:
- Not applicable. There is no mention of a training set as it's not an AI/ML device.

Summary

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K081215

Image /page/0/Picture/1 description: The image shows the logo for KJAYA MEDICAL. The logo is in black and white and features the word "KJAYA" in large, outlined letters. Below the word "KJAYA" is the word "MEDICAL" in smaller, solid letters.

KJAYA MEDICAL, LLC One Stamford Plaza 263 Tresser Boulevard, 9th Floor, Stamford, CT 06901 Telephone: 203-653-5015. Fax: 203-653-2999

510(k) Summary (per 21 CFR 807.92)

AUG 2 6 2008

I. Applicant: KJAYA Medical, LLC One Stamford Plaza 263 Tresser Boulevard 9th Floor Stamford, CT 06901 USA

Contact Person: Kovalan Muniandy, Managing Member Tel: 203-653-3496 Fax: 203-653-2999 e-mail: kovalan.muniandy@kjaya.com

Date prepared: February 26, 2008

II. Device Name

Proprietary Name: Volumina Common/ Usual Name: Picture Archiving and Communications System Classification Name: System, Image Processing, Radiological Regulation Number: 892.2050 Product Code: LLZ Classification; 2

III. Predicate Device

The Volumina is substantially equivalent to the following predicate devices:

. Synapse 3D Visualization Software OBLIQUUS (K061672) from FUJIFILM Medical Systems USA Inc.
Rtist for Fusion7D, (K033955) from Mirada Solutions, Ltd. .

IV. Indications for Use

V. Description of the Device

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Image /page/1/Picture/0 description: The image shows the text "KJAYA MEDICAL" in a stylized font. The word "KJAYA" is in a larger font size than the word "MEDICAL". The word "MEDICAL" is located directly below the word "KJAYA".

data.

For additional information refer to Section 11. Device Description

VI. Testing

Verification and Validation was conducted according to written protocols and the test outcomes were documented with test reports including pass/fail determination. Verification was monitored and cross referenced in the traceability matrix to ensure all requirements are verified.

Tests were executed under various environments representing actual operating environments and included laptops, desktops, and servers running Microsoft Windows XP, Microsoft Windows XP x64,and Microsoft Windows Server 2003. The various test environments also included connections via a variety of internet and network connections, including DSL, and Cable.

The test data was retrieved from a PACS database containing actual patient Raw Data. Some synthetic data of known dimensions and values was also used for verification and validation.

Due to the close relationship between the Client and Server modules, both were tested simultaneously.

Validation was undertaken to demonstrate that the Volumina Client and Server Modules together consistently fulfill the requirements within the intended use operates as intended under actual operating conditions by accepting the required parameters as input and by returning the expected output, and that the user interface provides a display that is consistent with the data that has been given.

A tabulation of Test Procedures, expected Results and Outcomes and are included in Appendix 16-C Traceability Matrix

For details please see Section 16. Software, Item 7. Verification & Validation Testing.

VII. Safety and Effectiveness

There are no substantial differences between the Volumina defined in this 510(k) submission and the stated predicate devices. They are similar to the technologies that are currently used in other similar medical devices.

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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 stylized eagle with three stripes forming its body and head, and three wavy lines forming its legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kjaya Medical, LLC % Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

AUG 2 6 2008

Re: K081215

Trade/Device Name: Volumina Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 8, 2008 Received: August 11, 2008

Dear Mr. Lehtonen:

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 (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 max 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 J

Sincerely vours.

Nancy C. Brogdon

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

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Enclosure

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510(k) Number (if known): K081215

Device Name: Volumina

Indications for Use:

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy brodon

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

Page 1 of

Regulation Number and Section

N/A