Images can be sent to it via the DICOM protocol, from modalities or other devices that are sources of medical images.
Images can subsequently be queried and retrieved via the DICOM protocol, to imaging workstations and other processing devices.
Internally, Vault is optimized to provide secure storage for a very large number of images, and to provide rapid retrieval on demand. To that end, Vault includes high capacity storage media, and has implemented hierarchical storage management software to manage cache storage effectively.

Device Description

Image Vault is a software package which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Image Vault is a PC-based, DICOMcompliant PACS device that is able to send & receive, display, store, and archive DICOM non-compressed and JPEG-compressed images. Images can be archived using standard magnetic tapes. It also has the ability to read/write a collection of images to/from CD-R media in a method defined by DICOM.

Images can be viewed using a simple display utility, for the purposes of properly identifying patients and their corresponding studies, and is not intended to be used for diagnosis.

Image Vault uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Image Vault.

AI/ML Overview

The provided document is a 510(k) summary for the Mitra Imaging, Inc. "Image Vault" device, submitted in 1997. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical performance studies usually associated with new technologies or higher-risk devices.

Therefore, many of the typical acceptance criteria and study details requested in your prompt (like specific performance metrics, sample sizes for test and training sets, number and qualifications of experts, MRMC studies, and detailed ground truth establishment) are not present in this document. The device is a PACS Image Archive System/Teleradiology System, which primarily deals with storage and viewing of images, not diagnostic interpretation or algorithm-driven analysis of medical images.

Here's an attempt to answer your questions based solely on the provided text, highlighting what information is available and what is missing.

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the format of quantitative performance metrics for a specific clinical task. Instead, the device's "performance" is demonstrated through a comparison chart showing its specifications against a predicate device, focusing on functional equivalence.

Table of Acceptance Criteria and Reported Device Performance

Criterion/Specification	Image Vault (Reported Performance)	Predicate Device (Kodak Cardiac Archive Station CAS 6000)
Graphical User Interface	Yes	Yes
Patient Demographics	Yes	Yes
Display Resolution	1024x768	1024x768
Communications	TCP/IP	TCP/IP
Image Review (Features)	Flip/Rotate/Pan/Zoom/Sequential	Flip/Rotate/Pan/Zoom/Sequential
CD Writers Supported	Yamaha CDR400, Yamaha CDR100	Kodak PCD Writer 600
CD Labeling	Yes	Yes
Temporary Image Storage	Yes	Yes
Image Archiving (Hard Disk)	Yes	Yes
Image Archiving (Magnetic Tape)	Yes	No
Magnetic Tape Drives Supported	ADIC Scalar 218, ADIC Scalar 448	No
Platform	PC	PC
DICOM compliance verification	Images compressed are properly identified per DICOM standard. (Implied)	Not explicitly stated, but assumed for equivalence.

Note: The "acceptance criteria" here are inferred from the comparison chart as the functional specifications and capabilities deemed equivalent to the predicate device. The performance is the Image Vault meeting these specifications.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Extensive testing of the software package has been performed by programmers, by non-programmers, and by potential customers." This indicates validation testing, but no specific sample size (e.g., number of images, number of patient studies) for a formal test set is provided.
- Data Provenance: Not specified. It's unclear if specific medical image datasets were used for validation, and if so, their origin (country, retrospective/prospective). The device handles "cardiac images," but no specific details about the types or sources of these images for testing are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This device is an archive/display system, not intended for diagnostic interpretation by users. Its functionality relates to storing, retrieving, and displaying images, not generating diagnostic output that would require "ground truth" to be established by medical experts for performance evaluation. The "potential customers" who tested the software are mentioned, but their qualifications and role in establishing ground truth are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Given the nature of the device and the lack of a defined "test set" for diagnostic performance evaluation, an adjudication method for ground truth is not mentioned.
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. This device is an image archive and display system; it does not incorporate AI or assist human readers in diagnostic tasks. Its purpose is to store and retrieve images, with a simple display utility "not intended to be used for diagnosis."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is software for PACS archive and display; it does not involve algorithms for standalone diagnostic performance. The validation focused on the software's ability to "send & receive, display, store, and archive DICOM... images." It is stated that "software is only used for control purposes and has no bearing on image quality. There is no image processing used with this software."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not specified. As the device's function is archiving and display, not diagnostic interpretation, the concept of "ground truth" for clinical accuracy is not relevant in this submission. Validation focused on functional correctness (e.g., proper storage, retrieval, display of images, DICOM compliance). The statement "Images that are compressed are properly identified in the images information as being compressed as specified by the entire DICOM standard" implies that DICOM standard compliance served as a form of "ground truth" for specific functionalities.
The sample size for the training set:
- Not applicable/Not specified. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It is a software package for data management.
How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML algorithm is described.

Summary

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K974102

P 1/4

JAN < U 1998

510(k) SUMMARY of Safety and Effectiveness

1.1 Company Identification
Mitra Imaging, Inc. 115 Randall Drive Waterloo, Ontario, Canada N2V IC5 Tel: (519) 746-2900 Fax: (519) 746-3745
1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116
1.3 Date of Submission
October 31, 1997
1.4 Device Name
CCCCCCCCCGGGG

Classification Name: Common/Usual Name: PACS Image Archive System/ Teleradiology System Image Vault

Proprietary Name:

Substantial Equivalence 1.5
The Image Vault software is substantially equivalent to the Kodak Cardiology Digital Archive & Review System (Cardiac Archive Station, CAS 6000), K960043.

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K974102 2/4

1.6 Device Description and Intended Use

Images can be viewed using a simple display utility, for the purposes of properly identifying patients and their corresponding studies, and is not intended to be used for diagnosis.

Image Vault uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Image Vault.

1.7 Software Development

Mitra certifies that the Image Vault software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software used in this product is used for cardiology and storage only and does not affect image quality.

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K974102

Substantial Equivalence Comparison Chart 1.8

Substantial Equivalence Comparison Chart (Image Vault)

Specification	Image Vault	Kodak Cardiac Archive Station CAS 6000
Graphical User Interface	Yes	Yes
Patient Demographics	Yes	Yes
Display Resolution	1024x768	1024x768
Communications	TCP/IP	TCP/IP
Image Review	Flip/Rotate/Pan/Zoom/Sequential	Flip/Rotate/Pan/Zoom/Sequential
CD Writers Supported	Yamaha CDR400Yamaha CDR100	Kodak PCD Writer 600
CD Labeling	Yes	Yes
Temporary Image Storage	Yes	Yes
Image Archiving (Hard Disk)	Yes	Yes
Image Archiving (Magnetic Tape)	Yes	No
Magnetic Tape Drives Supported:	ADIC Scalar 218ADIC Scalar 448	No
Platform	PC	PC
	Yes	Yes

Safety and Effectiveness 1.9

In accordance with the provisions of the Safe Medical Device Act of
the same with the providing a summary of safety and In accordance with the provisions of the Summary of safety and 1990, Mitra Imaging, Inc. Is providing a Sammary
effectiveness information regarding the Image Vault 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
entify of the software commerce and by potential customers. Extensive testing of the soltware passes and by potential customers.
programmers, by non-programmers, and by potential customers. programmers, by non-programmers, and by p on any posses and has no bearing on Software is only used for control purposso and has and master in this software.
image quality. There is no image processing used with this software.

Images that are compressed are properly identified in the images Images that are compressed are propenty tierhinet in the DCOM standard.
information as being compressed as specified by the entire information as being compressed as spoolibus by and the entire life of the image.

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K974102

Substantial Equivalence:

The Image Vault software is a software package used for archiving cardiac images and for writing to CD-ROM media. The intended use and technological characteristics of the system are similar to the Kodak Cardiac Archive Station CAS 6000. Any differences between the Image Vault 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 Image Vault software whose failure or latent design flaw would be expected to result in death or injury to a patient.

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Image /page/4/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/4/Picture/4 description: The image shows the text "JAN 20 1998" in a bold, sans-serif font. The text is arranged horizontally, with the month abbreviation "JAN" on the left, followed by the day "20", and then the year "1998". The text is black against a white background.

Mitra Imaging, Inc. c/o Gary J. Állesbrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116

Re:

K974102 Image Vault Dated: October 31, 1997 Received: October 31, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Allesbrook:

We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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 (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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 begin marketing 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 vitry diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions 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. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K974102

510(k) Number (if known):

Device Name: Image Vault

Indications for Use:

Vault is intended to act as a long term storage device (archive) for medical images.

Vault is a networked device that acts as a DICOM Storage Service Class Provider (SCP):

Images can be sent to it via the DICOM protocol, from modalities or other devices that are sources of medical images.
[ Images can subsequently be queried and retrieved via the DICOM protocol, to imaging workstations and other processing devices.
O Internally, Vault is optimized to provide secure storage for a very large number of images, and to provide rapid retrieval on demand. To that end, Vault includes high capacity storage media, and has implemented hierarchical storage management software to manage cache storage effectively.

Users:

The Vault will be located in a hospital department. The expected users are as follows:

Service personnel for installation, configuration and support.

[ System administrator within the department, who in many cases will be chief technologist or other designated clinical staff.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 901.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Gerrit C. Seymon

510(k) Number

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

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.