CD-R STATION AND VRS-2000 by ELECTROMED INTL., LTD.

CD writer (CD-R STATION) is intended solely for the engraving of DICOM compliant images from a local area network and the CD reader (VRS-2000) is used for viewing the images either from the CD or directly from a local area network.

The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R Station and VRS-2000 are used only for running the software and to temporarily buffer the images / reports to and from the CD and local area network.

Device Description

The CD-R STATION & VRS-2000 is comprised of two principle assemblies: a personal computer and a monitor. The CD-R STATION is to be interfaced to a local area network to receive DICOM compliant images which may then be recorded onto a CD. The VRS-2000 is a stand alone station which reads DICOM compliant images from a CD and displays them on a computer monitor. The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R STATION & VRS-2000 are used only for running the software and to temporarily buffer the images / reports which are to and from the CD.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ELECTROMED CD-R STATION & VRS-2000:

Disclaimer: The provided document is a 510(k) summary from 1997-1998 for a CD writer and reader for digital cardiac images. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the modern sense of medical device validation. Therefore, many of the requested points, particularly those related to clinical performance metrics and detailed study design (like sample sizes for a test set, expert involvement, and ground truth establishment for diagnostic accuracy), are not present in this document. The focus of this 510(k) is on the device's technical specifications and intended use being similar to existing cleared devices, and its safety and effectiveness without raising new questions.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically seen in modern diagnostic device submissions with specific sensitivity/specificity thresholds is not explicitly detailed in this 510(k) summary for the CD-R STATION & VRS-2000. This device is a component of a Picture Archiving and Communication System (PACS), specifically for writing and reading DICOM-compliant images to and from CDs for transport and viewing. Its acceptance criteria would primarily revolve around its ability to:

Successfully write DICOM-compliant images to a CD.
Successfully read DICOM-compliant images from a CD.
Display recorded images on a monitor.
Maintain image quality during writing, reading, and display comparable to the source.
Interface correctly with a local area network to receive DICOM images.
Meet safety standards (e.g., electrical safety).
Function without introducing new questions of safety or effectiveness compared to predicate devices.

The document does not provide a quantitative table of these criteria or specific metrics of "performance." Instead, it asserts equivalence based on the device's intended use and technological characteristics.

Study Information (Based on the provided document)

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

As explained above, explicit quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) and corresponding reported performance metrics are not provided in this 510(k) summary. The "performance" described is largely functional equivalence to predicate devices and adherence to standards like DICOM.

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

Test Set Sample Size: The document does not specify a sample size for a test set in the context of diagnostic performance evaluation. The "testing" implied would be functional testing to ensure DICOM compliance, successful writing/reading, and display, rather than a clinical performance study with "cases."
Data Provenance: Not applicable in the context of clinical data for a performance study. The data involved would be DICOM cardiac images from a local area network. No mention of country of origin or retrospective/prospective nature is made for any performance study data.

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

Not applicable/Not mentioned. This information would be relevant for a diagnostic performance study where expert interpretation is used to establish ground truth for a test set. This 510(k) is for a data transport/viewing device, not a diagnostic algorithm that interprets images.

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

Not applicable/Not mentioned. Adjudication methods are used in diagnostic performance studies to resolve discrepancies in expert interpretations. This is not the type of study presented here.

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. An MRMC study was not conducted (or at least not described in this summary). This device is a basic CD writer/reader for images, not an AI-assisted diagnostic tool.

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

Not applicable. This device is hardware and software for data handling, not an algorithm performing a diagnostic task in a standalone manner. Its function is to facilitate image transport and viewing for human interpretation, not to interpret images itself.

7. The type of ground truth used:

Not applicable. Ground truth (e.g., pathology, outcomes data) is established for diagnostic devices to verify their accuracy. For this device, the "ground truth" would simply be confirmation that the image written to the CD is identical to the source image, and that the image read from the CD and displayed is identical to what was written. This validation would be technical, not clinical diagnostic ground truth.

8. The sample size for the training set:

Not applicable. The device is not based on a machine learning model that requires a training set of data.

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

Not applicable. As no training set is used, no ground truth was established for it.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image is a black and white logo. The logo is circular and contains a stylized image of a structure that resembles a bridge or a tower. The structure is composed of geometric shapes, including triangles and horizontal lines. The background of the logo is black, and the structure is white.

ELECTROMED INTERNATIONAL

310, boul. Industriel, St-Eustache (Quebec) Canada J7R
Tel.: (514) 491-2100 Fax: (514) 491-4138

Certified

K974255

510(k) NOTIFICATION (CD-R STATION, VRS-2000)

Page: 1

JAN 27 998

APPENDIX C (510(k) SUMMARY)

510(k) SUMMARY

SUBMITTER: Electromed International 310 Industrial Blvd. St. Eustache, Quebec Canada J7R 5R4 Tel.: (514)-491-2100 Fax. (514)-491-4138

PREPARED BY: James Riedl

CLASSIFICATION NAME: Componet of "Picture Archiving and Communication System, CFR 892.2050 (CLASS II)"

COMMON OR USUAL NAME: CD writer and CD reader stations of digital cardiac images

PROPRIETARY NAME: CD-R STATION & VRS-2000

PREVIOUSLY MARKETED DEVICE TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED:

Sony Medical System's "Cinenet Cardiac Image Network" (K924708) and Diagnostic Archive's "Cardiac Image Management System (CIMS)" (K925961)

The CD-R STATION & VRS-2000 represents the first generation of Electromed International's CD writer and CD reader stations of digital cardiac images, Componets of "Picture Archiving and Communication System, CFR 892,2050 (CLASS II)". The Cinenet Cardiac Image Network, and the Cardiac Image Management System are complete systems which comprise of the following functions: image archiving; processing; analysis, management; and analysis. The CD-R STATION & VRS-2000 is intended solely for the engraving of DICOM compliant images from a local area network onto a CD, and for the viewing of the recorded images on the CD.

The CD-R STATION & VRS-2000 is comprised of two principle assemblies: a personal computer and a monitor. Unlike the Cinenet Cardiac Image Network which uses digital videocassettes as the archiving media, the CD-R STATION & VRS-2000 does not archive at all. The CD-R STATION is to be interfaced to a local area network to receive DICOM compliant images which may then be recorded onto a CD. The VRS-2000 is a stand alone station which reads DICOM compliant images from a CD and displays them on a computer monitor. The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R STATION & VRS-2000 are used only for running the software and to temporarily buffer the images / reports which are to and from the CD. Only the images of a single patient can be transferred to a single CD, whereas the Cinenet Cardiac Image Network incorporates a Data Storage Library for archival which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval.

October 24, 1997

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image is a black and white logo. The logo is a circle with a design inside of it. The design appears to be a bridge or some other type of structure. The structure has a trapezoidal base and a triangular top.

ELECTROMED INTERNATIONAL
310, boul. Industriel. St-Eustache (Quebec) Canada J7R 5R4

Image /page/1/Picture/2 description: The image shows a logo or emblem with the text "Certified ISO 9001 Certified" arranged in a stacked format. The text is in a bold, slightly distorted font, giving it a textured appearance. The word "Certified" appears twice, once at the top and once at the bottom, sandwiching "ISO 9001" in the middle.

510(k) NOTIFICATION (CD-R STATION, VRS-2000)

Page: 2

APPENDIX C (510(k) SUMMARY)

The CD-R STATION & VRS-2000 is to be connected to a 115/230V (+10%), 50/60Hz, 2.6/1.3A power source.

The configurable and add-on options being offered with the CD-R STATION & VRS-2000 is a CD label printer and a optional mobile cart.

Since the CD-R STATION & VRS-2000 can receive information and images in a DICOM compliant format, via a local area network, a CD-R Station may be connected to a VIEW ARCHIVING STATION (510k #K971176) to record the previously archived images onto a transportable media (CD).

Since the options or combination of options, as stated above, are available as an integral part of the CD-R STATION & VRS-2000, the device will inevitably be offered in various configurations while maintaining the intended use and technological characteristics presented here within.

The CD-R STATION & VRS-2000 does not in any way raise new questions of safety or effectiveness, when used as labeled, in comparison to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James Riedl Quality Director Electromed International 310 boul. Industrial St. Eustache (Quebec) Canada J7R 5R4

Re:

K974255 CD-R Station and VRS-2000 Dated: November 3, 1997 Received: November 13, 1997 Regulatory class: Unclassified Procode: 90 LMD

JAN 27 1998

Dear Mr. Riedl:

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 indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 notification submission does not affect any obligation you might 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 beeing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu
Lillian Yin, Ph.D.

Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

01/20/98 TUE 13:45 FAX 301 480 4224

CDRH DRAERD

Page_ of

510(k) Number (if known):

CD-R Station and VRS-2000 Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

David L. Benson

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.