This premarket notification covers the LAN and WAN teleradiology concept (transmission), and study information distribution functions. The CompuMed DICOM client is an on-site (LAN) or offsite (WAN or dial up) station for viewing patient information and images and reporting.

Device Description

The CompuMed DICOM client is a viewing station manufactured by CompuMed, Inc. The CompuMed DICOM client is an on-site (LAN) or offsite (WAN or dial up) station for viewing patient information and images and reporting. It supports industry standard information transmission and communication protocols.

AI/ML Overview

This document is a 510(k) summary for the CompuMed DICOM Client, submitted in 1995. It primarily focuses on demonstrating substantial equivalence to existing teleradiology products and does not contain the detailed performance study information requested.

Therefore, I cannot populate the table or answer most of your specific questions because the provided text does not include the type of information you are asking for regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted and why other questions cannot be answered:

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

Cannot be provided. The document does not define specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity, image quality parameters) nor does it report the device's performance against such criteria. The submission focuses on substantial equivalence based on intended use and technical characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be provided. The document does not describe a performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Cannot be provided. No reference to a test set or ground truth establishment by experts is made.

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

Cannot be provided. No test set or expert adjudication 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:

Cannot be provided. This document is for a DICOM client (a viewing station and communication software), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

Cannot be provided. The device is a viewing station and communication software, not a standalone diagnostic algorithm.

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

Cannot be provided. No performance studies or ground truth definitions are mentioned.

8. The sample size for the training set:

Cannot be provided. The device is not an AI/machine learning model, so there is no concept of a "training set."

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

Cannot be provided. Irrelevant as it's not an AI/ML model.

Summary of available information from the document:

Device Name: CompuMed DICOM Client
Intended Use: LAN and WAN teleradiology concept (transmission), and study information distribution functions. Viewing patient information and images and reporting.
Technological Characteristics: DICOM conformant, low-cost viewing workstation for on-site and off-site viewing and reporting.
Substantial Equivalence Claimed Against:
- CompuMed PC Teleradiology product
- Dejarnette Teleshare
- Line Imaging WinRad
- SIENET DRC (Magic View workstation)
Rationale for Substantial Equivalence: "The CompuMed DICOM client products have the same intended use and similar technical characteristics as the devices listed above."
Safety and Effectiveness Concerns: "The device labeling contains instructions for use. It includes indications for use and cautions. This information provides for safe and effective use of the device."

This 510(k) submission is a "pre-AI era" filing and therefore does not contain the types of performance study details now common for AI/ML-based medical devices.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

I. GENERAL INFORMATION

Establishment: Address: .
Registration Number:
. Contact Person:

CompuMed Inc 1200 No El Dorado Place C300 Tucson AZ 85715

2029024

Loren Larsen Manager, Regulatory Submissions 520-544-0544 FAX 520-296-2555

Date of Submission Preparation .
Device Name:
Trade Name: ● Classification:
for PACS (Picture Archiving

December 5, 1995

CompuMed DICOM Client No formal classifications have been issued and Communication Systems) or PACS components. For purposes of determining substantial equivalence, they have been considered to be accessories to medical imaging devices.

Performance Standards: .

None established under Section 514 of the Food, Drug, and Cosmetic Act

II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

. Device Description and Intended Use: This premarket notification covers the LAN and WAN teleradiology concept (transmission), and study information distribution functions.
The CompuMed DICOM client is a viewing station manufactured by CompuMed, Inc. The CompuMed DICOM client is an on-site (LAN) or offsite (WAN or dial up) station for viewing patient information and images and reporting. It supports industry standard information transmission and communication protocols.
Technological Characteristics: The LAN and WAN (Teleradiology) products described are DICOM conformant. The CompuMed DICOM client is a low-cost viewing workstation for on-site and off-site viewing and reporting.
. General Safety and Effectiveness Concerns: The device labeling contains instructions for use. It includes indications for use and cautions. This information provides for safe and effective use of the device.
Substantial Equivalence:

CompuMed DICOM client December 5, 1995 CONFIDENTIAL

510(k) Premarket Notification Page 44

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The CompuMed DICOM client addressed in this premarket notification, is
substantially equivalent to the following commercially system is and ochparited DICOM client addressed in this premarket notification,
subscription to the following commercially available devices:

CompuMed PC Teleradiology product .
Dejarnette Teleshare
Line Imaging WinRad
SIENET DRC (Magic View workstation)

The CompuMed DICOM client products have the same intended use and similar
technical characteristics as the devices listed above the occilipanted DICOM client products have the same
company consisteristics as the devices listed above.

Phillip Beuer

Signature

12/12/95
Date

CompuMed DICOM client

December 5, 1995 CONFIDENTIAL

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.