TigerView Professional is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data.

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

Device Description

TigerView Professional is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card.

AI/ML Overview

This 510(k) summary for Televere Systems TigerView Professional describes a Picture Archiving and Communication System (PACS) software. As such, the information provided focuses on its functional equivalence to predicate devices rather than clinical performance metrics typical of AI/ML-driven diagnostic devices.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the way one would expect for a diagnostic algorithm. Instead, the "performance" is implicitly tied to demonstrating functional equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Functional equivalence to legally marketed PACS systems	"TigerView Professional has been demonstrated to perform as intended." "Tiger View Professional is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS)."
Ability to acquire medical images from various sources	Receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners).
Ability to display, edit, review, store, print, and distribute images	Acquires, displays, edits (e.g., resize, adjust contrast, crop, annotate, etc.), reviews, stores, prints, and distributes images using standard PC hardware.
Compatibility with standard PC hardware	Runs on standard PC-compatible computers; compatible with various capture devices connecting via Network Adaptor, USB, PCI, parallel port, memory card, S-video, or SCSI.
Ability to store clinical notes, audio, and exam data	Enables the storage of clinical notes, audio recordings, and clinical exam data.

Study Details

Given the nature of this submission for a PACS system, a "study" in the clinical trial sense (with a test set, ground truth, and expert readers) is not described. The evaluation relies on demonstrating functional equivalence.

Sample size used for the test set and the data provenance: Not applicable/not specified. The "testing" mentioned is functional demonstration, not a clinical performance study with a test set of images.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. There is no mention of a ground truth established by experts for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not specified.
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. This device is a PACS system, not an AI-driven diagnostic aid.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a software platform, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the functional performance of predicate devices, which the new device is compared against for substantial equivalence.
The sample size for the training set: Not applicable. As a PACS system, it doesn't involve machine learning model training in the conventional sense.
How the ground truth for the training set was established: Not applicable.

Conclusion based on the provided text:

The submission for Televere Systems TigerView Professional is a 510(k) for a Picture Archiving and Communication System (PACS). The "study" referenced in the document is a demonstration of functional equivalence to predicate PACS devices (EagleSoft ChairSide Software Application and TigerScan/TigerView), rather than a clinical performance study with defined acceptance criteria, test sets, or ground truth for diagnostic accuracy, which would be typical for an AI/ML-driven diagnostic device. The manufacturer states that "TigerView Professional has been demonstrated to perform as intended" and is "substantially equivalent to legally marketed Image Processing Systems (i.e. PACS)."

Summary

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Kob/035

Televere Systems TigerView Professional Section 5.0, 510(k) Summary 510(k) Premarket Notification

Page 1 of 2

510(k) SUMMARY

General Information

JUN - 5 2006

Submitted by:	Televere Systems
	16275 South Monterey Road, Suite K
	Morgan Hill, CA 95037
	Phone: 408.778.1700
	Fax: 408.778.1733
Contact Person:	Mr. Randell Quaal
	16275 South Monterey Road, Suite K
	Morgan Hill, CA 95037
	Phone: 408.778.1700
	Fax: 408.778.1733
	Email: rquaal@tigerview.com
Date Prepared:	April 14, 2006

Device Name

Trade Name:	TigerView Professional
Common Name:	Picture archiving and communications system
Classification Name:	System, Image Processing, Radiological,21 CFR 892.2050

Predicate Device

Manufacturer	Product Name	510(k) No.
EagleSoft, A Patterson Co.	EagleSoft ChairSide SoftwareApplication	K982422
Tau Corp.	TigerScan/TigerView	K955237

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Device Description

Intended Use

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

Technological Comparison

TigerView Professional, TigerScan/TigerView, and EagleSoft ChairSide are each software applications that have similar indications for use and overall function and perform in a similar manner with respect to image processing systems (i.e. PACS).

Testing

TigerView Professional has been demonstrated to perform as intended.

Conclusions

Tiger View Professional is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol.

JUN - 5 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Televere Systems % Ms. Melissa Mahall Director, Regulatory Affairs Bio-Reg Associates, Inc. 6304 Belmont Circle, Bldg 2 MOUNT AIRY MD 21771

Re: K061035

Trade/Device Name: TigerView Professional Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 14, 2006 Received: April 14, 2006

Dear Ms. Mahall:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in bold letters. The logo is surrounded by text that reads "Dedicated to the science of sound nutrition". The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

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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 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" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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

Kol 1035 510(k) Number (if known):

TigerView Professional

Sponsor Name:

Televere Systems

Indications for Use:

Device Name:

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

Prescription Use X (21 CFR 801 Subpart D)

And/Or

Over-The-Counter Use (21 CFR 807 Subpart C)

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leggion

n of Reproductive. Abdomina adiological Devic

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).