DIGITAL IMAGING SYSTEM by CAMTRONICS, LTD.

The provided text is a 510(k) summary for the Camtronics Digital Imaging System, submitted in 1995. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a clinical study for device performance against specific metrics. Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary is comparing the features and specifications of the new device to predicate devices to argue for substantial equivalence, not against pre-defined acceptance criteria for performance.

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

This information is not provided. The document explicitly states: "Performance data: Not required for determination of substantial equivalence for this class of device." This indicates that a formal study with a test set and associated data provenance was not conducted or submitted for this specific regulatory pathway.

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):

This information is not provided. Since performance data and a test set are stated as "not required," there would be no ground truth establishment by experts for such a study.

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

This information is not provided. As no test set performance data was required or provided, there would be no adjudication method.

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:

This information is not provided. The device described is a "Digital Imaging System," a Picture Archiving and Communications Device, intended for image acquisition, display control/image processing, input/output control, and patient data management. It predates the widespread concept of AI assistance in medical imaging and its primary function is not to interpret images or assist human readers in that capacity. Therefore, an MRMC study on reader improvement with AI assistance would not be applicable to this device or its regulatory submission context in 1995.

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

This information is not provided. Given the device's function as an imaging system, not an interpretive algorithm, a standalone performance study in the modern sense of AI algorithms would not have been relevant or conducted for this submission.

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

This information is not provided. As no performance study with a test set was required or presented, there is no mention of ground truth types.

8. The sample size for the training set:

This information is not provided. As this is a digital imaging system and not a machine learning algorithm in the modern sense, the concept of a "training set" as it relates to AI/ML would not apply. The device's functionality is based on established engineering principles for image acquisition, processing, and display.

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

This information is not provided. Similar to point 8, the concept of a training set and its associated ground truth establishment is not applicable to this type of device and its regulatory submission in 1995.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of the Camtronics Digital Imaging System to existing predicate devices based on feature comparison. It explicitly states that "Performance data: Not required for determination of substantial equivalence for this class of device." Therefore, the document does not contain information about acceptance criteria, performance studies, test/training sets, or ground truth establishment that would typically be found in submissions for devices requiring such data (e.g., AI/ML-driven diagnostic devices).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Camtronics Medical Systems. The logo consists of a stylized "C" shape on the left, with three horizontal lines inside. To the right of the "C" is the word "Camtronics" in a sans-serif font, with the words "MEDICAL SYSTEMS" in smaller letters below. The logo is black and white.

Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The sequence appears to be 'K954159'. The characters are written in a dark ink, and the background is white. The characters are somewhat stylized, with the '9' having a distinct loop at the top.

510(k) Summary

MAR 1 9 1996

Date prepared: August 28, 1995

Name of contact person: Robert Kriedermann

Device trade name: Digital Imaging System Common name: Digital Imaging System

Classification name: Medical Image Picture Archiving and Communications Device

Predicate substantially equivalent devices: Camtronics Ltd. Video Plus (K941979), Siemens Medical Systems Fluorospot H version 2 (K914525)

Device description: Digital image recording and display system fo use in a cardiac catheterization laboratory or radiography/fluoroscopy suite.

Intended use:

Image Acquisition .
. Display Control/Image Processing
Input /Output Control .
. Patient Data Management

Predicate device specifications comparison:

	Principal Device	Predicate Device	Predicate Device
Feature	Camtronics DigitalImaging System	Camtronics Video Plus(K941979)	Siemens Fluorospot Hversion 2 (K914525)
Matrix size	$512^2$ to $2068^2$	$512^2$ to $1024^2$	$1024^2$
Max. acquisition rate	60 fps	60 fps	8 fps
Bit depth	8, 10, or 12	8	8
Image storage	1 gigabyte minimum	1 gigabyte minimum	650 megabyte
Networking	yes	yes	yes
Supported procedures
Fluoro Acquisition	yes	yes	yes
Fluoro Loop Record	yes	yes	yes
Roadmapping FluoroAcquisition	yes	yes	yes
Spot Film Verification	yes	yes	yes
Digital Spot Acquisition	yes	yes	yes
Digital SubtractionAngiographyAcquisition (DSA)	yes	yes	yes
Peripheral AngiographyAcquisition (PERI)	yes	no	yes
Digital TomographyAcquisition (TOMO)	yes	no	yes
Rotational AngiographyAcquisition	yes	no	yes
ECG Gated Acquisition	yes	no	no
ECG Trace(s) Display	yes	no	no
Cine	yes	yes	no
Filmless Cine	yes	yes	no
Electrophysiology (EP)	yes	no	no
Synchronized BiplaneAcquisition	yes	yes	no

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Page 2 Camtronics Digital Imaging System 510(k) Summary August 28, 1995

	Principal Device	Predicate Device	Predicate Device
Feature	Camtronics DigitalImaging System	Camtronics Video Plus(K941979)	Siemens Fluorospot Hversion 2 (K914525)
Window/level	yes	yes	yes
Edge enhancement	yes	yes	yes
Zoom	yes	yes	yes
Roam	yes	yes	yes
Roadmapping	yes	yes	yes
Peak opacification	yes	yes	yes
Remask	yes	yes	yes
Pixel shift	yes	yes	yes
Annotation	yes	yes	no
Qualitative analysis	yes	yes	no

Predicate device specifications comparison (continued):

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ance data: Not required for determination of substantial equivalence for this class of device.

Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device

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).