The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching Archiving and Sommercess to previous imagery.

Device Description

The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5, SPARCstation 20, or UltraSparc) with pre-installed proprietary software, 2) the magnetic cache, a Sun SPARC storage Redundant Array of Inexpensive Disks (RAID) subsystem, and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox or a Digital Linear Tape (DLT) library. The RAID subsystem, combined with either the CD jukebox or DLT library, are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz.

AI/ML Overview

This document is a 510(k) summary for a PACS Storage Device, specifically the KODAK DIGITAL SCIENCE™ (KDS) Medical Image and Information Library (MIL). It primarily focuses on the device's technological specifications and its substantial equivalence to a predicate device, rather than clinical performance or studies involving human expertise. Therefore, many of the requested categories are not applicable or cannot be answered from the provided text.

Here's an breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the FDA's "substantial equivalence" determination. The performance is described in terms of technical specifications.

Feature / Criteria	Predicate Device (K960981)	This 510(k) Device (K972380)	Acceptance/Performance
Range of Storage	8 GB to 216 GB	12 GB - 20 TB	Improved storage capacity (within expected PACS archival capabilities)
Type of Interface	SCSI	SCSI	Equivalent
Type of Media	5.25" CD-Recordable	5.25" CD-Recordable or Digital Linear Tape (DLT)	Expanded media options (DLT added)
Jukebox Support	Yes, 150-CD	Yes, 150-CD or 588 DLT Cartridges	Enhanced jukebox capacity for DLT
Compression	Yes, lossless 2:1	Yes, lossless 2:1 or lossy to 50:1	Equivalent lossless, added lossy compression
DICOM Conformant	Yes, Native	Yes, Native	Equivalent, DICOM conformance is a key functional requirement
HIS/RIS Interface	Yes	Yes	Equivalent
Host Platform	Sun	Sun (SPARCstation 5, 20, or UltraSparc)	Equivalent
Database Structure	Distributed	Distributed	Equivalent
Indications for Use	Not explicitly stated	DICOM conformant archival product designed for use within a PACS	Functionally equivalent as an archive within a PACS
Regulatory Class	Class II	Unclassified (but later determined substantially equivalent for marketing)	Functionally equivalent to Class II predicate

Study Information:

The provided document describes a 510(k) premarket notification process, which determines "substantial equivalence" to a predicate device rather than conducting a new clinical study to establish performance against acceptance criteria in the same way a device with clinical efficacy claims would. The "study" here is essentially the comparison of features and technical specifications to the predicate device.

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

Not applicable. This is a technical comparison of device features, not a clinical study involving a test set of data or patient cases.

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)

Not applicable. No ground truth based on expert review or clinical data was established for a test set.

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

Not applicable. No test set requiring expert adjudication was used.

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

Not applicable. This device is a PACS storage and archival system, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a PACS storage and archival system; it does not contain a standalone algorithm for diagnostic or analytical performance that would be evaluated in this manner.

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

Not applicable. The "truth" in this context is the technical compliance with DICOM standards and the stated technical specifications, and the functional equivalence to the predicate device. This is assessed by comparing technical documentation and features.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a training set.

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

Not applicable. As there is no training set, there is no ground truth for it.

Summary

{0}------------------------------------------------

SEP 11 1997

Safety and Effectiveness Information 7.0

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS X972380

DATE PREPARED: June 23, 1996 I.

SUBMITTER: II.

Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8026

CONTACT PERSON: III.

Stan E. Tillman Director, Regulatory Affairs Health Imaging Division, Dallas (972) 454-1642

IV. DEVICE NAME:
Trade Name - KODAK DIGITAL SCIENCE™ (KDS) Medical Image and Information Library (MIL)

Common Name - PACS Storage Device (Archive)

V. DEVICE CLASSIFICATION
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750.
VI. PREDICATE DEVICE
Kodak Digital Science Medical Image and Information Library--K960981
VII. DESCRIPTION OF DEVICE
The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5, SPARCstation 20, or UltraSparc) with pre-installed proprietary software, 2) the magnetic cache, a Sun SPARC storage Redundant Array of Inexpensive Disks (RAID) subsystem, and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox or a Digital Linear Tape (DLT) library. The RAID subsystem, combined with either the CD jukebox or DLT library, are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz.

{1}------------------------------------------------

KODAK DIGITAL SCIENCE Premarket Notification

INDICATIONS FOR USE VIII.

COMPARISON OF FEATURES V.

K-number	This 510(k)	K960981
Range of Storage	12 GB - 20 TB	8 GB to 216 GB
Type of Interface	SCSI	SCSI
Type of Media	5.25" CD-RecordableorDigital Linear Tape (DLT)	5.25" CD-Recordable
Jukebox, Maximum	Yes, 150-CDor588 DLT Cartridges	Yes, 150-CD
Compression	Yes, lossless 2:1orlossy to 50:1	Yes, lossless 2:1
DICOM Conformant	Yes, Native	Yes, Native
HIS/RIS Interface	Yes	Yes
Host Platform	Sun	Sun
Database Structure	Distributed	Distributed

6/97

{2}------------------------------------------------

Image /page/2/Picture/16 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ 1997

Stan E. Tillman Director, Regulatory Affairs Eastman Kodak Company Health Imaging Division Medical Imaging Systems 18325 Waterview Parkway Dallas, Texas 75252

Re:

K972380 "Kodak Digital Science™ Medical Image Archive" Dated: June 23, 1997 Received: June 26, 1997 Regulatory class: Unclassified Procode: 90 LMB

Dear Mr. Tillman:

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 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 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 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

{3}------------------------------------------------

510(k) Number (if known): _K9723 3 80

Device Name: Kodak Digital Science™ Medical Image and Information Library (MIIL)

INDICATION FOR USE:

ﻨﻴﻨﺘﺎ

ﺴﻴﺔ

DICOM conformant archival product (storage library) designed for use within a Picture Archiving and Communications System (PACS).

(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 CRF 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Elinil A. Segerson

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972380

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.