The PMD Viewer Software is intended to provide off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150 Doppler ultrasound studies on a PC. PMD Viewer may only be operated independently, as a software-only product. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.

Device Description

This device is a software-only version of the Spencer Technologies digital Transcranial Doppler ultrasound system, the TCD100M/PMD150, and is described as the PMD Viewer.

The modification of the TCD100M/PMD150 implemented in the PMD Viewer provides physicians and technologists with the same data viewing, playback, and report generation features of the TCD100M/PMD150 off-line on a standard PC utilizing Windows XP SP2 or VISTA. All software features can be controlled with a standard keyboard and wheel mouse. Because it can read the proprietary binary file formats of the predicate (parent) device, the TCD100M/PMD150, the PMD Viewer displays images without any compression, duplicating the original quality of the images on the TCD100M/PMD150.

AI/ML Overview

This 510(k) summary is for a software-only medical device (PMD Viewer) that displays previously acquired ultrasound data. As such, the acceptance criteria and study data provided in the document focus on ensuring the software accurately reproduces the data from the original device without degradation.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic task. This is because the PMD Viewer is a display and review tool, not a diagnostic algorithm that makes interpretations or classifications.

Instead, the acceptance criteria are implicitly met by demonstrating that the PMD Viewer accurately replicates the functionality and image quality of the predicate (parent) device (TCD100M/PMD150) when viewing its proprietary binary file formats. The core acceptance criterion is accurate and faithful reproduction of the original data and images without degradation or alteration.

The reported device performance is described as:

"Because it can read the proprietary binary file formats of the predicate (parent) device, the TCD100M/PMD150, the PMD Viewer displays images without any compression, duplicating the original quality of the images on the TCD100M/PMD150."
"All functions for the review of the PMD device files are the same as reviewing the files on the predicate (parent) device, TCD100M/PMD150, with respect to intended use and indications for use, principles of operation, and technological characteristics and design."

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

The document does not specify a separate "test set" in the context of diagnostic performance. Instead, it refers to the ability of the PMD Viewer to read and accurately display "the proprietary binary file formats" of the TCD100M/PMD150. This implies that the testing involved using existing data files generated by the predicate (parent) device.

Sample Size: Not explicitly stated, as the nature of the device (viewer) means the "test set" is the range of files it's designed to read. The implication is that it can handle any file generated by the TCD100M/PMD150.
Data Provenance: Not explicitly stated (e.g., country of origin). The data would be "previously acquired information on cerebral arterial blood flow velocity measurements and the occurrence of micro-embolic signals" from TCD100M/PMD150 studies. It is implied to be retrospective, as it's "previously acquired" data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the traditional sense for a diagnostic AI. The "ground truth" for this device is the fidelity of the displayed data compared to the original data on the TCD100M/PMD150. This is a technical validation, not a clinical diagnostic validation requiring expert interpretation for ground truth. The validation would involve technical verification to ensure that data displayed on the PMD Viewer is identical to how it appears on the TCD100M/PMD150, likely performed by engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical adjudication required for a software viewer that simply displays existing data.

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 applicable. The PMD Viewer is a standalone software for viewing and playback, not an AI or CAD (Computer-Aided Detection/Diagnosis) system that assists human readers in diagnostic tasks. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the PMD Viewer is a standalone software product in the sense that it operates independently on a standard PC to display data. However, it's not a standalone prescriptive algorithm or AI that provides a diagnosis. Its standalone performance is defined by its ability to accurately read and display the proprietary file formats without degradation, replicating the functionality of the original device. This is implicitly what the substantial equivalence claim is based upon.

7. The Type of Ground Truth Used

The "ground truth" for the PMD Viewer is the original, uncompressed digital data and the visual representation of that data as it appears on the TCD100M/PMD150 diagnostic ultrasound system. Essentially, the ground truth is the primary source data itself, and the PMD Viewer's task is to reproduce that ground truth faithfully.

8. The Sample Size for the Training Set

Not applicable. The PMD Viewer is not an AI/machine learning algorithm that requires a "training set." It is a software application designed to read and display specific file formats.

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

Not applicable, as there is no training set for this type of software.

Summary

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5. 510(K) SUMMARY

K092204

A. Submitter

Spencer Technologies 701 16th Avenue Seattle, WA 98122 USA 206-329-7220

B. Establishment Registration Number: 3033518

C. Contact

OCT - 8 2009

Name	Tony Williams
Title	VP Quality Assurance/Regulatory Affairs
Telephone:	206-329-7220 x118
FAX:	206-329-7230
Email:	williamstc@spencertechnologies.com

D. Submission Date: 16 July 2009

E. Trademark and Common Name

Spencer Technologies PMD Viewer

F. Classification of the device

Classification Name	Picture Archival and Communications System
Classification Panel	Radiology
CFR Number	21 CFR 892.2050
Device Class	Class II
Product Code	LLZ

G. Predicate Device

The PMD Viewer, addressed in this premarket notification, is substantially equivalent to the following commercially available devices:

Manufacturer	Trade Name	510(k) No	Product Code
Acuson Corporation	CSV12 Software Viewer	K022896	90 LLZ
Spencer Technologies	TCD 100M/PMD150 DiagnosticUltrasound System	K002533	90 IYN

Note: In this document we refer to the Acuson Viewer as the "predicate device", and to the PMD Viewer as the "predicate (parent) device".

H. Device Description

This device is a software-only version of the Spencer Technologies digital Transcranial Doppler ultrasound system, the TCD100M/PMD150, and is described as the PMD Viewer.

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-Intended Use

PMD Viewer is intended to provide the same data viewing, playback, and report generation features of its predicate (parent) device, TCD100M/PMD150, Doppler ultrasound studies, offline on a standard PC. The data consists of previously acquired information on cerebral arterial blood flow velocity measurements and the occurrence of micro-embolic signals in the cerebral arterial blood flow. PMD Viewer operates exclusively as a stand-alone software product on a standard PC. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.

J. Technological Characteristics and Substantial Equivalence

PMD Viewer is a medical image device that is used with computer hardware in a picture archiving and communications system user environment. It has the same intended use and technical characteristics as the predicate device, the Acuson Corporation CSV12 Software Viewer, listed above. 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 the images and information being displayed and printed.

PMD Viewer utilizes commercially available computer platforms and operating systems (Microsoft Windows XP/Vista) as does the predicate CSV12 Software Viewer. PMD Viewer does not produce any original medical images. All functions for the review of the PMD device files are the same as reviewing the files on the predicate (parent) device, TCD100M/PMD150, with respect to intended use and indications for use, principles of operation, and technological characteristics and design. It is comparable in key safety and effectiveness features. Studies may be transmitted in DICOM or native TCD100M/PMD150 format, to an integrated magnetooptical drive, or over a network.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized eagle. The eagle is depicted with three stripes forming its body and wings, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Tony Williams VP Quality Assurance/Regulatory Affairs Spentech, Inc. Doing Business as Spencer Technologies 701 16th Avenue SEATTLE WA 98122

OCT = 8 2009

Re: K092204

Trade/Device Name: PMD Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 16, 2009 Received: July 22, 2009

Dear Mr. Williams:

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); medical device reporting of medical

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Page 2 -

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATION FOR USE

510(k) Number (if known): K092204

Device Name: PMD Viewer

Indications for Use:

Prescription Use X (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)

Arvin M. White

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

510(k) Number K092204

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).