Pegasys Ultra is a nuclear medicine image processing and display workstation that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine procedure. The Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Device Description

Pegasys Ultra is a UNIX-based SUN display workstation and central processor, a high resolution processing console and TeleLOGIC remote service package. It provides for operator interaction with comprehensive ADAC PEGASYS clinical software provided by ADAC Laboratories and includes On-Line User Documentation.

The workstation allows a qualified operator to process and enhance the data, reconstruct data sets, produce quantitative data from regions of interest, display images, curves and text. Images can be displayed in color, show fluorescence intensity, and different zoom factors. Identification parameters include volume, size, and shape. Use of multiple viewports allows the operator to display images with different color maps, intensities, and zoom factors simultaneously. The PEGASYS desktop contains graphic icons allowing selection of an application such as Renal Analysis, and a menu selection, which consists of a main menu and submenus for image processing of the multiple applications.

AI/ML Overview

The provided 510(k) summary for the PEGASYS Ultra nuclear medicine imaging workstation does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format typically expected for medical device performance evaluation (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device per FDA 510(k) requirements. This means the device is considered safe and effective because it has similar technological characteristics and intended use to a device already legally marketed.

Here's a breakdown of the available information and what is missing based on your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy).	"PEGASYS Ultra has met all its specifications, demonstrating substantially equivalent performance to its predicate device, and is safe and effective for its intended use." The document states "the basic algorithms and original calculations have not changed" from the predicate device.

Missing Information:

Specific quantitative performance metrics (e.g., accuracy, precision, processing speed benchmarks, image quality metrics) that would typically constitute acceptance criteria for a new medical image processing device.
Measured performance values against those criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Non-clinical testing was performed for Verification and Validation testing" but does not specify a "test set" in the context of patient data or a clinical study. The testing seems to refer to internal engineering and software validation.

Missing Information:

Sample size for any test set involving patient data.
Data provenance (e.g., country of origin of data, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not describe any study that involved establishing ground truth with experts. The "results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions," but this refers to the intended use of the device, not a performance study where experts establish ground truth.

Missing Information:

Number of experts.
Qualifications of experts.

4. Adjudication Method for the Test Set

No adjudication method is described because no expert-based ground truth establishment is detailed.

Missing Information:

Adjudication method (e.g., 2+1, 3+1, none).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. The submission focuses on substantial equivalence to a predicate device rather than a comparative effectiveness study with human readers.

Missing Information:

Whether an MRMC study was done.
Effect size of human reader improvement with AI vs. without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an "image processing and display workstation" that "provides software applications" to "process, analyze, and display medical images/data." The results are intended "as a tool, by a nuclear physician." This implies a human-in-the-loop system. While the "basic algorithms and original calculations have not changed" from the predicate, no standalone algorithm-only performance is independently reported as a primary safety and effectiveness metric. The "Summary of Testing" refers to verification and validation of the system against specifications.

Missing Information:

Explicit reporting of standalone algorithm performance.

7. The Type of Ground Truth Used

No particular type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for performance evaluation in the context of clinical accuracy. The "Summary of Testing" refers to meeting product specifications.

Missing Information:

Type of ground truth used for performance studies.

8. The Sample Size for the Training Set

No training set is mentioned. The device's "basic algorithms and original calculations have not changed" from the predicate device, suggesting a more traditional software development approach rather than a machine learning model that would require a distinct training set.

Missing Information:

Sample size for the training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not applicable.

Missing Information:

How ground truth for the training set was established.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the 510(k) summary):

The provided 510(k) summary for K993946, PEGASYS Ultra, describes a primary method of demonstrating safety and effectiveness through substantial equivalence to a predicate device (PEGASYS Nuclear Medicine Imaging Computer, K892358).

Key Points from the document:

Acceptance Criteria: Not explicitly defined in terms of clinical performance metrics. The implicit acceptance criterion is that the device "met all its specifications, demonstrating substantially equivalent performance to its predicate device, and is safe and effective for its intended use."
Study Design: The "Summary of Testing" states that "Non-clinical testing was performed for Verification and Validation testing." This typically refers to internal software and hardware testing to ensure the device functions as designed and meets internal engineering specifications.
- The document emphasizes that "the basic algorithms and original calculations have not changed" from the predicate device. The improvements are in "upgraded hardware" and an "enhanced user interface," increasing "speed" and general sophistication.
Proof of Meeting Criteria: The claim of meeting criteria is based on:
- Verification and Validation testing against ADAC Laboratories' internal procedures and specifications.
- The assertion that the core image processing algorithms and calculations are the same as those in the legally marketed predicate device.
- The FDA's decision of substantial equivalence through the 510(k) process, which relies on comparing the new device's intended use and technological characteristics to a predicate, and finding them similar enough that the new device raises no new questions of safety or effectiveness.

It is important to note that for a traditional 510(k) cleared device like this from 2000, particularly a workstation for image processing, the level of detailed clinical performance data (like sensitivity/specificity against a gold standard, or MRMC studies) was not typically required in the same way it might be for a novel diagnostic algorithm or AI-powered device today. The focus was on demonstrating that the new device performs its intended functions comparably to existing, proven technology.

Summary

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510(k) SUMMARY

K993946

Submitter name:	ADAC Laboratories, Inc.
Submitter Address:	540 Alder DriveMilpitas, CA 95035
Submitter Telephone:	(408) 468-3766
Submitter Fax:	(408) 468-3050
Contact Person:	Janice Brown
Date Summary Prepared:	February 23, 2000

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510(k) SUMMARY

Device trade name:	PEGASYS Ultra
Common name:	Nuclear Medicine Imaging Workstation
Classification name:	Picture Archiving and Communications System(per 21CFR section 892.2050)
Predicate Devices:	PEGASYS Nuclear Medicine Imaging Computer, K892358

Device Description:

Intended Use:

Summary of Technological Characteristics Compared to Predicate Devices:

The predicate device is the "PEGASYS" Nuclear Medicine Imaging Computer, Class II, K892358/A. The FDA determined "PEGASYS" (K892358/A) was substantially equivalent to devices marketed prior to May 28, 1976, the enactment date of the Medical Device Amendments. Both the PEGASYS "Ultra" and the "PEGASYS" Nuclear Medicine Imaging Computer are workstations with SUN UNIX based computers, high resolution graphics and image display consoles for use with ADAC software image processing applications. Both devices use menus and allow the qualified operator to define regions of interest. The PEGASYS "Ultra" software and hardware is more sophisticated, and has progressed with the field of computers and nuclear medicine, but,

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the basic algorithms and original calculations have not changed. The functions have been built into the monoliths and protocols in use today, and in conjunction with the upgraded hardware have added speed and an enhanced user interface for the processing of nuclear images, which aid the physician towards a suggestive diagnosis. Additionally, the acquisition software portion has been removed to a separate computer system and is no longer a part of the base Pegasys software.

Summary of Testing

Non-clinical testing was performed for Verification and Validation testing. Testing were completed in compliance with ADAC Laboratories procedures to demonstrate that the Pegasys "Ultra" has met all its specifications, demonstrating substantially equivalent performance to its predicate device, and is safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

19 2000 MAR

Janice E. Brown, RAC Corporate Director, Regulatory Affairs ADAC Laboratories 540 Alder Drive Milpitas, CA 95035

Re:

K993946 Pegasys Ultra Dated: February 23, 2000 Received: February 25, 2000 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Ms. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the inclusions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Aproval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requirition (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission you micht have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 requilation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510 (k) NUMBER (IF KNOWN) : __ K993946

DEVICE NAME: __ PEGASYS Ultra

INDICATIONS FOR USE:

Pegasys Ultra is a nuclear medicine image processing and display workstation that provides software applications used to process, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use_ (Optional Format 1-2-96)

David A. Segner
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT 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).