The intended user of this device is a DICOM software package that will enable any hospital PC with adequate radiographic monitor and enough memory to be utilized with Radiological image viewer. This uson as the Lumisys, Lumiscan film Quality scanners, such as the Lambyo, . digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.

Device Description

The Film Express software is a DICOM software package that will enable any hospital PC with adequate radiographic monitor and enough memory to be utilized with Radiological image viewer. This uson as the Lumisys, Lumiscan film Quality scanners, such as the Lambyo, . digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.

AI/ML Overview

This 510(k) summary for K970652 does not contain the detailed information typically provided in a study to establish acceptance criteria and device performance. The device, "Film Express," is a teleradiology system (a DICOM software package) for archiving and transmitting radiological images. It explicitly states, "Software is only used for control purposes and has no bearing on image quality. There is no image processing used with this software." This strongly implies that the device is not an AI/CADe/CADx device that performs image analysis or provides diagnostic assistance.

Therefore, many of the requested categories for AI/CADe/CADx devices, such as "acceptance criteria and reported device performance" in the sense of diagnostic accuracy, ground truth, expert consensus, MRMC studies, or standalone performance, are not applicable in this context. The document focuses on demonstrating substantial equivalence to other teleradiology systems based on functional specifications and adherence to standards like DICOM.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not applicable:

Acceptance Criteria and Study for K970652: Film Express Teleradiology System

Based on the provided 510(k) summary, the "Film Express" software is a teleradiology system designed for archiving and transmission of radiological images. It explicitly states that it "has no bearing on image quality" and "no image processing is used with this software." Therefore, its "acceptance criteria" and "device performance" are focused on its functionality, adherence to standards, and safety as an image management system, rather than diagnostic accuracy or image analysis.

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

Since this is not an AI/CADe/CADx device, the "acceptance criteria" revolve around functional equivalence and compliance, not diagnostic metrics. The "performance" is demonstrated through functional specifications and comparison to predicate devices.

Acceptance Criteria (Inferred from Substantial Equivalence and Device Description)	Reported Device Performance (From Specifications and Comparison Chart)
Functional Equivalence: Ability to perform core teleradiology functions.	Graphical User Interface: Yes
Scanner Support: Compatibility with specified radiological quality scanners.	Scanners Supported: Radiological Quality scanners, such as Lumisys 20/50/75/85/100/150/200
Patient Demographics Handling: Ability to manage patient data.	Patient Demographics: Yes
Display Resolution Support: Capable of displaying images at common resolutions.	Display Resolution: 1024x768
Communication Protocol: Adherence to standard communication protocols.	Communications: TCP/IP
Image Review Functions: Essential image manipulation capabilities.	Image Review: Flip/Rotate/Pan/Zoom
Temporary Image Storage: Provision for temporary image storage.	Temporary Image Storage: Yes
Platform Compatibility: Operates on common computing platforms.	Platform: PC
Image Compression Support: Ability to handle common image compression formats.	JPEG: Yes
DICOM Printing: Support for DICOM Basic Printing.	DICOM Basic Printing: Yes
DICOM Conformance: Adherence to DICOM standard, especially for compression identification.	Images compressed are properly identified as specified by the DICOM standard; compression identification remains with the image.
Safety: No expectation of death or injury due to software failure.	"No software component... whose failure or latent design flaw would be expected to result in death or injury to a patient."

2. Sample size 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 in the 510(k) summary. The document mentions "Extensive testing of the software package has been performed by programmers, by non-programmers, and by potential customers," but it does not specify a quantifiable "test set" in terms of images or patient cases, nor does it detail data provenance. The testing appears to be functional and user acceptance testing rather than a clinical study with a specific image sample set.

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 applicable/not provided. As the device does not perform image analysis or provide diagnostic information, there is no "ground truth" to be established by experts in the context of diagnostic accuracy. The testing focused on functional integrity and adherence to technical standards.

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

This information is not applicable/not provided. Given that the device does not involve diagnostic interpretation or ground truth establishment by experts, adjudication methods for clinical performance are irrelevant.

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 applicable. The "Film Express" is a teleradiology system for image management and transmission, not an AI or CAD system. Therefore, MRMC studies evaluating human reader performance with or without AI assistance are not relevant to this device.

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

This information is not applicable. The device is not an algorithm for image analysis. Its performance is its ability to manage and transmit images as intended.

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

This information is not applicable. As a teleradiology system without image analysis functions, there is no "ground truth" in the clinical diagnostic sense for this device. The "truth" for this device lies in its functional correctness (e.g., successful transmission, correct display, adherence to DICOM standards).

8. The sample size for the training set

This information is not applicable/not provided. This device is a software application, not a machine learning model that requires a "training set" in the AI sense. Its development involved traditional software development, testing, and validation.

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

This information is not applicable/not provided. As this is not an AI/ML device, there is no "training set" or "ground truth" established for it in that context.

Summary

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K970652

510(k) SUMMARY

Company Identification 1.1
MAY - 2 1997

Mitra Imaging, Inc. 115 Randal Dr. Waterloo, Ontario, Canada N2V 1C5 Tel: (519) 746-2900 Fax: (519) 746-3745

Official Correspondent 1.2
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116
Date of Submission 1.3
February 21, 1997
Device Name 1.4
Classification Name:

, PACS

Common/Usual Name:

Teleradiology System

Proprietary Name:

Film Express

Substantial Equivalence 1.5
The Film Express software is substantially equivalent to the Lumisys DICOM TOOLKIT, Imageshare 910, or Statview.

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Device Description and Intended Use 1.6

The intended user of this device is a DICOM software The Intended user of this dovies any hospital PC with adequate package that will enable any nooplar is a radiographic monitor and enough memory to be utilized with Radiologicalimage viewer. This uson as the Lumisys, Lumiscan film Quality scanners, such as the Lambyo, .
digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.

Software Development 1.7
Mitra certifies that the Film Express software is designed, i Mitra centifies that the i minuted according to written developed, tested and valuation identify individuals within the procedures. These processible for developing and approving organization responsible for and testing, validation testing product specifications, county and vesting, and in this product is and fleid maintenance. This command only and does not affect image quality.
Substantial Equivalence Comparison Chart 1.8

Specification	Film Express	DICOM Toolkit	Imageshare/FD (910)	Statview/DX
Graphical User Interface	Yes	Yes	No	Yes
Scanners Supported	RadiologicalQuality scanners,such as Lumisys20/50/75/85/100/150/200	50, 75, 150, 200	50, 75, 100, 150, 200	50, 75, 100
Patient Demographics	Yes	Yes	Yes	Yes
Display Resolution	1024x768	1024x768	N/A	800x600,1024x768,1280x1024,1200x1600
Communications	TCP/IP	TCP/IP	TCP/IP	TCP/IP
Image Review	Flip/Rotate/Pan/Zoom	Flip/Rotate/Pan/Zoom	Flip/Rotate	Flip/Rotate/Pan/Zoom
Temporary ImageStorage	Yes	Yes	Yes	Yes
Platform	PC	PC	PC	PC
JPEG	Yes	No	Yes	No
DICOM Basic Printing	Yes	No	No	No

Substantial Equivalence Comparison Chart (Film Express)

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Safety and Effectiveness 1.9

In accordance with the provisions of the Safe Medical Device Act of 1990, Mitra Imaging, Inc. is providing a summary of safety and effectiveness information regarding the Film Express software.

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and indication for use.

The hardware components specified (but not supplied) are all "off the shelf" computer components.

Validation and Effectiveness:

Extensive testing of the software package has been performed by programmers, by non-programmers, and by potential customers. Software is only used for control purposes and has no bearing on image quality. There is no image processing used with this software.

Images that are compressed are properly identified in the image information as being compressed as specified by the DICOM standard. This compression identification remains with the image for the entire life of the image.

Substantial Equivalence:

The Film Express software is a software package used for archiving and transmission of radiological images. The intended use and technological characteristics of the system are similar to the Dejarnette, Imageshare 910 Film Digitizing Acquisition Station. Any differences between the Film Express software and the equivalent device have no significant influence on safety or effectiveness.

Its is our conclusion that there is no software component that we know of in the Film Express software whose failure or latent design flaw would be expected to result in death or injury to a patient.

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.