The Olicon Imaging Systems, NT Archive Systems stores and retrieves digital images together with information about the DICOM standard network protocol. communicates with other devices via the DICOM standard network protocol.

Device Description

The NT ARCHIVE SYSTEM is a device for filing digital radiological images for storage and retrieval. The system design is layered with three storage technologies; magnetic, magneto-optical and DLT tape.

AI/ML Overview

This document is a 510(k) summary for the Olicon Imaging Systems, Inc. NT Archive Systems. It describes a digital archive system for medical images.

Based on the provided text, the device described is a digital archive system for medical images, not a medical device that diagnoses or treats conditions. Therefore, concepts like "acceptance criteria" related to diagnostic accuracy, "device performance" in terms of clinical outcomes, "sample sizes" for test sets of patients, "ground truth" derived from expert consensus or pathology, or "multi-reader multi-case (MRMC) comparative effectiveness studies" are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (Olicon Archive K922164) based on its technological characteristics, indications for use, and compliance with general regulatory standards.

Here's a breakdown of the requested information based on the provided text, indicating where the information is not applicable (N/A) for this type of device:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (as implied by the 510(k))	Reported Device Performance (as stated in the 510(k))
Storage and retrieval of digital radiological images	The NT Archive System is a device for filing digital radiological images for storage and retrieval. The system design is layered with three storage technologies; magnetic, magneto-optical and DLT tape.
Archival of medical images with associated information	The NT Archive Systems will be used to digitally store medical images for archival together with information about the images.
Communication via DICOM standard network protocol	Communicates with other devices via the DICOM standard network protocol.
Compliance with Federal Performance Standards (21 CFR, part 1000)	The NT Archive is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
Manufactured in accordance with voluntary standards	The NT Archive has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
Hazard analysis conducted	The submission contains the results of an hazard analysis. All potential hazards have been classified as MINOR.
Substantially equivalent to predicate device (K922164)	The NT Archive is basically an update of the current Olicon Archive (K922164). The submitter certifies the device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence.

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

N/A. This device does not involve a "test set" in the sense of clinical data or patient images for performance evaluation of a diagnostic algorithm. It's an archiving system. The "test" would be functional testing of the software and hardware for storage and retrieval, which is not detailed in this summary.

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)

N/A. Ground truth for clinical interpretation is not applicable as this is an archiving system, not an interpretive device.

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

N/A. Adjudication methods are not applicable as there is no "test set" for clinical evaluation.

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

N/A. MRMC studies are not applicable as this is an archiving system, not a diagnostic AI system intended to assist human readers.

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

N/A. The concept of "standalone performance" for an algorithm for clinical interpretation is not applicable here. The device itself is "standalone" in its primary function of archiving, but its performance is measured by its functional capabilities (storage, retrieval, DICOM compatibility) rather than diagnostic accuracy. The document states: "Images and information being stored and retrieved are interpreted by a physician, providing ample opportunity for competent human intervention," indicating the device's role is to support, not replace, human interpretation.

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

N/A. No clinical ground truth is applicable. The "ground truth" for this device would be whether it accurately stores and retrieves the digital images as intended.

8. The sample size for the training set

N/A. There is no "training set" in the context of machine learning or AI as this device is an archive system.

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

N/A. Not applicable, as there is no training set mentioned or implied for this type of device.

Summary

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DEC - 2 1997

5 1 0(k) Summary of Safety and Effectiveness

for the Olicon Imaging Systems, Inc. NT Archive Systems

This 5 1 0(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

4 September, 1997

Submitter's Information:

Olicon Imaging Systems, Inc. 120 Columbia Avenue, Suite 600 Aliso Viejo, CA 92656 phone: (714) 360-1830 (714) 362-1522 fax:

Trade Name, Common Name, Classification:

Trade Name - Olicon Imaging Systems, Inc. ARCHIVE SYSTEMS Common Name - Digital Archive Internal Company Names - NT Archive, 02Archive, Archive,

Predicate Device:

OLICON IMAGING SYSTEMS, INC. Device: RAYTEL DIGITAL IMAGING SYSTEMS K922164 510(k) Number: 05/08/92 Date Received: 01/21/93 Decision Date: Substantially Equivalent Decision: Panel Code device reviewed by:Radiology Panel Code device classified by:Radiology LMD Product Code: Class II Classification:

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510(k) Summary of Safety & Effectiveness (continued)

Device Description:

Indications for Use:

The NT Archive Systems will be used to digitally store medical images for archival together with information about the images. The typical users are trained medial professionals.

Technological Characteristics:

The device does not contact the patient, nor does it control any life sustaining devices. Images and information being stored and retrieved are interpreted by a physician, providing ample opportunity for competent human intervention.

The NT ARCHIVE is a Microsoft Windows NT system that is basically an update of the current Olicon Archive (K922164) which is UNIX Solaris based. The NT Archive will provide a 3 tier storage system with built in backup file redundancy.

Conclusion:

I certify that the 510(k) Pre-Market Notification for the above referenced device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to Olicon Imaging Systems, Inc. Archive Svstem - K922164.

The NT Archive is subject to and in compliance with the Federal 1. Performance Standards, defined in 21 CFR, part 1000.
The NT Archive has been and will be manufactured in accordance with 2. the voluntary standards listed in the enclosed voluntary standard survev.
The submission contains the results of an hazard analysis. All potential ദ. hazards have been classified as MINOR.

Signature

Richard L. Paulsen CEO. Olicon Imaging Systems, Inc.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olicon Imaging Systems, Inc. c/o Herman Oosterwijck OTech , Inc. 6741 Grant Avenue Plano, Texas 75024

K973463 NT Archive Systems Dated: September 4, 1997 Received: September 12, 1997 Regulatory class: Unclassified Procode: 90 LMB

DEC - 2 1997

Dear Mr. Oosterwijck:

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 the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 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 Act. 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 (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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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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510(k) Number:

Device Name: Olicon Imaging Systems, Inc. - NT Archive Systems

Indications For Use:

The Olicon Imaging Systems, NT Archive Systems stores and retrieves The Olicon Imaging Oystems, NY ... .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . digital images together with information about the DICOM standard network protocol.
communicates with other devices via the DICOM standard network protocol.

Typical users of this system are trained professionals, including but not Typical users of this, nurses and medical technicians.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Elmer A. Sperry

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_197.340

Olicon Imaging Systems, Inc. NT Archive 510(k)

Regulation Number and Section

§ 892.2010 Medical image storage device.

(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(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.