3D INVIVO BY CSIST by CHUNG-SHAN INSTITUTE OF SCIENCE AND TECHNOLOGY

3D inVIVO™ is a PACS System 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 radiologist, physicians, technicians, and nurses.

The 3D inVIVO™ is indicated for capture and storage of 2D images from ultrasound systems and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume and are not intended for use in diagnosis or quantitative measurements.

Device Description

The CSIST 3D inVIVO™ interactive 3D diagnostic ultrasound system (3DUS) acquires a set of successive 2D ultrasound images from Ultrasound system and coverts them into a 3D ultrasound image, stores the 3DUS images in the Image Archive of DICOM Image Server, views patient data and medical images via the Intranet or Internet, supplies image availability information to the Department System Scheduler/Order Filler with DICOM 3.x standard, and accept schedule information and updated procedure information from the Department System Scheduler/Order Filler with HL7 version 2.4 standard.

CSIST Interactive 3DUS system is a PC-based Modality with operating system of MS Windows NT/2000/XP. 3D inVIVO™ provides the advanced process functions, such as :

Supports the freehand scanning, 3D image acquisition, and 3D reconstruction.
Acquires images from ultrasound system in real time.
Supports the ultrasound image storage and ultrasound multi-frame image storage.
Converts non-DICOM to DICOM format.
Supports the GUI functions: zoom, pan, pseudo-color setting, threshold setting, Gamma correction, and thumbnail.
Provides the DICOM query and retrieve services (images and presentation states).
Displays the cut planes of 3D image along the long axis or the short axis.
Provides 3D rendering modes: MIP, X-ray, translucent, surface, slicing, and 3D cine.
Supports distance/area/angle measurements.
Supports Tele-medicine (audio, video, and text) between regional medicine center and remote clients.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a study that proves the device meets those criteria in the form of a performance study. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with quantitative acceptance criteria.

However, based on the provided text, we can infer some general "acceptance criteria" related to functionality and safety, and describe what the document does say about meeting these.

Here's an attempt to structure the answer based on the information available, while acknowledging what is not present:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, etc., which would typically be found in a performance study for AI-powered diagnostic devices. The acceptance criteria here are more related to functional equivalence and safety.

Acceptance Criteria (Inferred from 510(k) submission)	Reported Device "Performance" (as per 510(k) submission)
Functional Equivalence:
Acquire and store 2D ultrasound images	"acquires a set of successive 2D ultrasound images from Ultrasound system" and "Acquires images from ultrasound system in real time." "Supports the ultrasound image storage and ultrasound multi-frame image storage."
Reconstruct into 3D ultrasound images	"coverts them into a 3D ultrasound image" and "reconstructing them into 3D ultrasound images." "Supports the freehand scanning, 3D image acquisition, and 3D reconstruction."
Store 3DUS images in DICOM Image Server	"stores the 3DUS images in the Image Archive of DICOM Image Server"
View patient data/medical images via Intranet/Internet	"views patient data and medical images via the Intranet or Internet"
Provide image availability info to Department System	"supplies image availability information to the Department System Scheduler/Order Filler with DICOM 3.x standard"
Accept schedule/procedure info from Department System	"accept schedule information and updated procedure information from the Department System Scheduler/Order Filler with HL7 version 2.4 standard."
Support GUI functions (zoom, pan, color, etc.)	"Supports the GUI functions: zoom, pan, pseudo-color setting, threshold setting, Gamma correction, and thumbnail."
Provide DICOM query and retrieve services	"Provides the DICOM query and retrieve services (images and presentation states)."
Display cut planes of 3D image	"Displays the cut planes of 3D image along the long axis or the short axis."
Provide 3D rendering modes	"Provides 3D rendering modes: MIP, X-ray, translucent, surface, slicing, and 3D cine."
Support distance/area/angle measurements	"Supports distance/area/angle measurements."
Support Tele-medicine features	"Supports Tele-medicine (audio, video, and text) between regional medicine center and remote clients."
Safety and Intended Use:
Not for diagnosis or quantitative measurements	"These images provide an approximate representation of the 3D volume and are not intended for use in diagnosis or quantitative measurements."
Device does not contact patient	"The device is a software application and does not contact the patient..."
Physician retains interpretative control	"A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."
Potential hazards classified as Minor	"The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor." This implies that safety testing and analysis was performed to ensure the device poses minimal risk.
Substantially equivalent to predicate device	"The 510(k) Pre-Market Notification for 3D inVIVO™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This is the ultimate "acceptance criterion" for a 510(k), demonstrating that its technological characteristics and performance are as safe and effective as a legally marketed predicate. "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (FDA letter)

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

The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the performance of the device against quantitative metrics. This 510(k) submission primarily relies on demonstrating functional equivalence to a predicate device and software verification/validation, rather than a clinical performance study with patient data.

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

This information is not provided as the submission does not detail a study involving expert-established ground truth for a test set of medical images.

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

This information is not provided as no test set with expert-established ground truth 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

No MRMC comparative effectiveness study is mentioned in the provided text. The device's indications for use explicitly state that the images "are not intended for use in diagnosis or quantitative measurements," which further suggests that a study comparing human reader performance with and without device assistance for diagnostic tasks would not be relevant to this specific 510(k) submission.

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

No standalone performance study is described for the algorithm. Given the device's purpose as an image archiving, transmission, and visualization system for approximate 3D reconstruction, and its explicit statement that it's "not intended for use in diagnosis or quantitative measurements," a standalone diagnostic performance study would not be applicable or expected for this submission. The device is a tool for visualizing and managing ultrasound data, with human interpretation always in the loop.

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

No specific ground truth type is mentioned or implied as there is no detailed performance study described that would require ground truth data for diagnostic or quantitative purposes. The "ground truth" for this device's acceptance is primarily its functional consistency with its description and substantial equivalence to the predicate device, as well as adherence to standards (DICOM, HL7).

8. The sample size for the training set

The document does not mention any training set size as it pertains to a traditional machine learning or AI model development that would typically require a training set. The "3D inVIVO™" is described as an "interactive 3D diagnostic ultrasound system" that converts 2D images into 3D, and provides various processing and rendering functions. While 3D reconstruction can involve algorithms, the submission doesn't present it as a deep learning or AI model in the modern sense requiring a large labeled training set for diagnostic purposes.

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

As no training set is described (see point 8), no information is provided on how ground truth for a training set was established.

Summary

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Ko3 1567

OCT = 2 2003

Image /page/0/Picture/2 description: The image shows a logo with a trident inside of a black circle on the left and the text "CSIST" on the right. The trident is white and has three prongs. The text "CSIST" is in a simple sans-serif font.

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

July 25, 2003

Submitter's Information: 21 CFR 807.92(a)(1) CHUNG-SHAN INSTITUTE OF SCIENCE AND TECHNOLOGY 481 CHIA-AN SEC. CHUNG-CHENG RD. LUNG-TAN, TAO-YUAN, CHINA (TAIWAN) 32500

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	3D inVIVO™ by CSIST
Common Name:	Picture Archiving Communications System
Device Classification:	892.2050
Name:	System, Image Processing

Predicate Device: 21 CFR 807. 92(a)(3)

Device ClassificationName	SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Regulation Number	892.2050
510(k) Number	K030635
Device Name	THE OBSIDIAN PACS SYSTEM
Applicant	OBSIDIAN MEDICAL TECHNOLOGY, INC.5108 CORONA CT.PLEASANTON, CA 94588
Contact	BIANCA GREEN
Product Code	LLZ
Decision Date	03/28/2003

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

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Image /page/1/Picture/0 description: The image shows a logo with a trident inside of a black circle on the left and the text "CSIST" on the right. The trident is white and has three points. The text "CSIST" is in a simple sans-serif font and is also white. The logo appears to be for an organization or company called CSIST.

CSIST Interactive 3DUS system is a PC-based Modality with operating system of MS Windows NT/2000/XP. 3D inVIVO™ provides the advanced process functions, such as :

Supports the freehand scanning, 3D image acquisition, and 3D reconstruction. ।
Acquires images from ultrasound system in real time. --
Supports the ultrasound image storage and ultrasound multi-frame image storage. |
-Converts non-DICOM to DICOM format.
Supports the GUI functions: zoom, pan, pseudo-color setting, threshold setting, | Gamma correction, and thumbnail.
Provides the DICOM query and retrieve services (images and presentation states). -
-Displays the cut planes of 3D image along the long axis or the short axis.
Provides 3D rendering modes: MIP, X-ray, translucent, surface, slicing, and 3D ! cine.
Supports distance/area/angle measurements. -
Supports Tele-medicine (audio, video, and text) between regional medicine center -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------and remote clients.

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

The 3D inVIVO™ is indicated for capture and storage of 2D images from ultrasound svstems and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume and are not intended for use in diagnosis or quantitative measurements.

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

The device is a software application and 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.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for 3D inVIVO™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. 3D inVIVO™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the caduceus. The text is written in a sans-serif font and is in all capital letters.

Public Health Service

OCT - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chung-Shan Institute of Science and Technology c/o Mr. Carl Alletto 1100 Lakeview Blvd. DENTON TX 76208

Re: K031567

Trade/Device Name: 3D inVIVO™ by CSIST Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 26, 2003 Received: July 28, 2003

Dear Mr. Aletto:

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. lxxx	(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

l'age 2

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Image /page/4/Picture/0 description: The image shows a logo with a trident symbol inside a black circle on the left and the text "CSIST" on the right. The trident is white and has three prongs pointing upwards. The text "CSIST" is in a simple, sans-serif font and is also white. The logo appears to be for an organization or company named CSIST.

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(Indications for Use Form)

510(k) Number: K831567

Device Name:

CSIST Interactive 3D Diagnostic Ultrasound System called "3D inVIVO™

Indications for Use:

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

f Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

David Ch. Lyman

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