THE OBSIDIAN PACS SYSTEM by OBSIDIAN MEDICAL TECHNOLOGY, INC.

The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses.

The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements.

Device Description

The Obsidian PACS System is comprised of components that connect to an analog or digital medical imaging device (ultrasound, CT, MRI, digitizer), transmit image or patient data, and store image or patient data. The transmission of data can occur internally or externally using a local area network or Internet connection.

AI/ML Overview

The provided text is a 510(k) Summary for the Obsidian PACS System. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics.

Here's a breakdown of what is and is not in the provided text, based on your requested information:

1. A table of acceptance criteria and the reported device performance

Not found. The document states that "The documentation submitted on the device system reflects this level of risk and consist of the following documents: Architectural design chart, Hazard analysis, DICOM conformance statement." It concludes that these documents "contain adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device." This suggests a reliance on design and risk analysis documentation rather than a performance study with specific acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not found. There is no mention of a test set, sample size, or data provenance.

3. 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)

Not found. Since there's no mention of a test set or performance evaluation, there's no information about experts or ground truth establishment.

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

Not found. No test set or human review process is 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 found. The device is a PACS system for acquiring, transmitting, viewing, and storing image/patient data, and a 3D Ultrasound Image Router. It is not an AI-assisted diagnostic tool, and therefore, an MRMC comparative effectiveness study to measure human reader improvement with AI assistance would not be applicable or expected for this type of device based on the provided information.

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

Not found. No standalone performance studies are mentioned. The document explicitly states: "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This reinforces that the system is a tool supporting human interpretation, not an autonomous diagnostic algorithm.

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

Not found. No ground truth is mentioned, as no performance study is described.

8. The sample size for the training set

Not found. There is no mention of a training set. This is consistent with the nature of a PACS system, which primarily handles data management and display, rather than an AI/ML algorithm that requires training.

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

Not found. As no training set is mentioned, there's no information on how its ground truth would be established.

In summary: The provided document is a 510(k) Summary for a Picture Archiving and Communication System (PACS) and a 3D Ultrasound Image Router. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics, indications for use, and risk assessment (minor level of risk). It does not include a clinical performance study with acceptance criteria, sample sizes, expert involvement, or ground truth establishment relevant to AI/ML device evaluations. The approval is based on documentation such as architectural design, hazard analysis, and DICOM conformance.

Summary

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K030635

Image /page/0/Picture/1 description: The image shows the logo for Obsidian Medical Technology. The logo features the word "OBSIDIAN" in large, bold, sans-serif font, with the words "MEDICAL TECHNOLOGY" in a smaller font size underneath. Above the word "OBSIDIAN" is a graphic of a globe with binary code (1s and 0s) encircling it.

5108 Corona Court · Pleasanton, CA 94588 · tel: (925) 426-3111 · www.obsidianmedical.com

510(k) Summary of Safety and Effectiveness

Date Prepared: April 22, 2002 Submitter's Information: 21 CFR 807.92(a)(1) Obsidian Medical Technology, Inc. Contact: Bianca Green 5108 Corona Court Pleasanton, CA 94588 Tel: (925) 426-3111 Fax: (925) 426-3001 Trade name, Common Name and Classification: 21 CFR 807.92(a)(2) The Obsidian PACS System Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892 2050 Name: System, Image Processing, Radiology Predicate Device: 21 CFR 892.92(a)(3) Manufacturer: Echo Tech 3D Imaging Systems, Inc. Device: Echo Tech Easy 3D 510(k) Number: K013088 Date Received: 03/06/2002 Decision Date: 04/04/2002 Substantially Equivalent Decision: Panel Code device reviewed by: Radiology Panel Code device classified by:Radiology Product Code: LLZ

Class II - 892.2050 Classification:

Device Description: 21 CFR 807 92(a)(4)

Indications for Use: 21 CFR 807 92(a)(5)

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Technological Characteristics: 21 CFR 807 92(a)(6)

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. This device transmits data on and off-site.

Conclusion: 21 CFR 807 92(b)(3)

In accordance with the FDA document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," the level of risk of the Obsidian PACS System was considered to be minor. The documentation submitted on the device system reflects this level of risk and consist of the following documents:

. Architectural design chart
. Hazard analysis
DICOM conformance statement .

These documents contain adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device. The Obsidian PACS System will be manufactured in accordance with the standards listed in the enclosed specifications documentation.

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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 horizontal lines representing its wings. 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

MAR 2 8 2003

Obsidian Medical Technology, Inc. % Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K030635

Trade/Device Name: Obsidian PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 18, 2003 Received: March 20, 2003

Dear Ms. Danielson:

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 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

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INDICATIONS FOR USE

510(k) Number (if known): _K & ك ك ك ك ك

Device Name: The Obsidian PACS System

Indications for Use:

Prescription Use

David R. Seymm

(Division Sign-O Division of Reproductive and Radiological D 510(k) Number

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).