IMAGEACCESS SYSTEM by STORCOMM, INC.

The intended use of the device is to allow storage and retrieval of medical images for purposes of assisting in the diagnosis and/or treatment of diseases.

Device Description

The ImageACCESS® system is a complete clinical image management system providing direct capture, retrieval, storage, and transmission of images, reports and patient demographics. These images include, but are not limited to, Flat film Radiology, computer Tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET). Images from such devices are directly recorded/retrieved on/from optical disk recorders.

AI/ML Overview

This document is a 510(k) premarket notification for the StorCOMM ImageACCESS system, which is a clinical image management system. The provided text primarily focuses on the administrative aspects of the 510(k) submission and FDA approval, rather than detailed performance study results or acceptance criteria for a new device.

Therefore, many of the requested categories about acceptance criteria and detailed study information cannot be extracted from this document as they are not present. This submission is for substantial equivalence to an existing device (K931454) and not for a novel device that requires extensive clinical performance studies as would be expected for, say, a new diagnostic algorithm.

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

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

Cannot be extracted. The document is a 510(k) summary for an image management system, not a diagnostic device with specific performance metrics like sensitivity or specificity. No acceptance criteria or performance data for such metrics are provided. The "performance" described is its function as an image management system (capture, retrieve, storage, transmission).

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

Cannot be extracted. No information on a "test set" in the context of diagnostic performance is mentioned. The device is a system for managing images, not for performing diagnostic tests on images itself.

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 extracted. This document does not describe studies that require expert-established ground truth for a test set.

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

Cannot be extracted. Not applicable, as no test set requiring 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 extracted. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

Cannot be extracted. This is an image management system, not an algorithm, so standalone performance in the sense of a diagnostic algorithm is not relevant or described.

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

Cannot be extracted. Not applicable, as no diagnostic performance study establishing ground truth is described.

8. The sample size for the training set

Cannot be extracted. This is not a machine learning or AI device that would typically have a training set.

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

Cannot be extracted. Not applicable, as no training set or ground truth for it is described.

In summary, the provided 510(k) document pertains to an image management system and emphasizes its substantial equivalence to a previously cleared device. It does not contain the detailed performance study information typically found for novel diagnostic devices, especially those incorporating AI or requiring clinical validation against a "ground truth."

Summary

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StorCOMM ImageACCESS 510(k) Premarket Notification 06/25/97 JAN - 2 1998 Premarket Notification [510(k)] Summary K973805 M. This summary document is being submitted in accordance with section 807.92(c). : ・・ The submitter of the 510(k) is: George M. Treiber, Vice President, Chief Technical Officer StorCOMM, Inc. 8849 San Jose Boulevard Jacksonville, FL 32217 904-731-1289 Voice 904-730-8587 Fax Date Summary Prepared: June 25, 1997 Device Subject to this 510(k): ImageACCESS® System Trade Name: Clinical Image Management System Common Name: Classification Name: Medical Image Digitizer, Proposed 21CFR 892.2050, Class II; FR Vol.61, No 232, 12/2/96

Comparison with Predicate Devices:

The device which is the subject of this 510(k), ImageACCESS®, is substantially equivalent to the same device before the current modifications which was authorized for marketing via 510(k) K931454, decision date 12/14/93.

Device Description:

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Indications for Use:

The intended use of the device is to allow storage and retrieval of medical images for purposes of assisting in the diagnosis and/or treatment of diseases.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

George M. Treiber Vice President, Chief Technical Officer StorCOMM: Inc. 8649 Baypine Road #7 Corporate Plaza Jacksonville, FL 32256

Re: K973805 ImageACCESS®, Clinical Image Management System Dated: September 25, 1997 Received: October 6, 1997 Unclassified Procode: 90 LMD

JAN - 2 1998

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Dear Mr. Treiber:

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 interstate 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, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Aproval), 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 vour device in the Federal Register. Please note: this response to your premarket notification 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 marked 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. Liao 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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510(k) Number (if known):	K973805
Device Name:	IMAGE ACCESS

Indications For Use:

The intended use of the device is to allow storage and retrieval of medical images for The michood abo of the diagnosis and/or treatment of diseases.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

William Yn

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

Prescription Use X
(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.