The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.

Device Description

The Imation™ Trimatic™ Digital System is intended for use as a system to convert radiographic films into a digitized format for use in a hospital or other clinical image management system. The digitized image receives patient and exam information and is then forwarded into a DICOM compliant image management system. The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-rays.

AI/ML Overview

The provided text describes a medical device, the Imation™ Trimatic™ Digital System, and its 510(k) submission for clearance. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or AI effectiveness.

The "Performance Data" section lists voluntary standards related to safety (UL, IEC), laser safety (21 CFR 1040, IEC), and electromagnetic compatibility (EN standards). It does not describe any performance metrics for image quality, diagnostic accuracy, or clinical outcomes that would be typical acceptance criteria for a medical imaging device.

Therefore, many of the requested sections regarding acceptance criteria, performance, and study design cannot be extracted from the provided text.

Here's what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
UL1950 (Safety of Information Technology Equipment)	Conforms to standard
21 CFR1040 (Laser Safety Standards)	Conforms to standard
IEC825 (Laser Safety Standards)	Conforms to standard
EN60601-1-2 Class A (Electro-Magnetic Compatibility)	Conforms to standard
EN55011 1991-97 (Radiated and Conducted Immunity)	Conforms to standard
EN55014-1 1993-97 (Conducted Immunity)	Conforms to standard
EN61000-4-2 1995 (Electro-Static Discharge)	Conforms to standard
EN61000-4-3 1996 (Radiated Radio-frequency)	Conforms to standard
ENV 50204 1995 (Immunity to RF Telephone Emissions)	Conforms to standard
EN61000-4-4 1995 (Electronic Fast Transfer)	Conforms to standard
EN61000-4-5 1995 (Surge)	Conforms to standard
EN61000-4-6 1996 (Conducted immunity)	Conforms to standard
EN61000-4-8 1993 (Power Frequency Magnetic Field)	Conforms to standard
EN61000-4-11 1994 (Power Line Fluctuation)	Conforms to standard
Faithfully digitizing standard x-rays	"The digitizer has the resolution capable of faithfully digitizing standard... x-rays." (Implied performance)
Faithfully digitizing mammographic x-rays	"The digitizer has the resolution capable of faithfully digitizing... mammographic x-rays." (Implied performance)
Digital image 12 bit depth	"The digital image has 12 bit image depth" (Technical specification met)
DICOM 3.0 format	"The digital image... is in Dicom 3.0 format." (Technical specification met)
Scan rate and spot size adjusted for film type	"The scan rate and spot size are adjusted depending on the film type" (Technical specification met)
Accurately capture 5 line pairs per mm for standard films	"accurately capture either 5 or 10 line pairs per mm for standard... films" (Technical specification met)
Accurately capture 10 line pairs per mm for mammographic films	"accurately capture either 5 or 10 line pairs per mm for... mammographic films" (Technical specification met)

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

Not provided. The document focuses on regulatory compliance, safety, and technical specifications, not a clinical test 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):

Not provided. This information would be relevant for an AI or diagnostic performance study, which is not described.

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

Not provided.

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:

No MRMC study was done or reported. This device is a digitizer, not an AI-assisted diagnostic tool. The document explicitly states: "Digital images generated by the Trimatic Digital System are interpreted by competent medical practitioners, offering ample opportunity for competent human intervention where warranted." This indicates no AI assistance for interpretation is part of this device.

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

Not applicable/Not provided. The device is a digitizer; it does not perform standalone diagnostic algorithms.

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

Not applicable/Not provided. The ground truth for the listed performance data relates to compliance with engineering and safety standards, and whether technical specifications (like resolution, bit depth) are met. It does not involve diagnostic ground truth.

8. The sample size for the training set:

Not applicable/Not provided. This device is a film digitizer, not an AI model requiring a training set.

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

Not applicable/Not provided.

Summary

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JAN 25 1999

Image /page/0/Picture/1 description: The image shows the logo for Imation, a company that was spun off from 3M. The logo features a hand holding a wand, with a trail of plus signs and dots emanating from the wand. The text "IMATION" is written in a bold, sans-serif font below the wand and hand. The phrase "Borne of 3M Innovation" is written in a smaller font below the company name.

Imation Corp. 1 Imation Place Oakdale, MN 55128-3414 612 704 4000 phone 800 537 4675 fax

510(k) Summary

Nov 25, 1998

Imation Corp. 1 Imation Place Oakdale MN 55128-3414 Contact: Stephen G. Slavens 1 Imation Way DIS-4B-75 Oakdale MN 55144-3414 Phone: 651-704-3536 FAX: 651-704-4469

Device:	Trade name:	Imation™ Trimatic™ Digital System
	Common name:	PACS System
	Classification name:	Image Processing System LLZ
		21 CFR 892.2020 Class II

Predicate device:

The Imation™ Trimatic Digital System is comprised of cleared or exempt devices with the exception of the digitizer, which is identical to the digitizer in clearance (K982785) except for minor film feeding hardware and communication software.

Description and Intended Use of Device:

Technological Characteristics:

The Imation™ Trimatic™ Film Digitizer uses a laser scanner to scan and digitize the film image. The digital image has 12 bit image depth and is in Dicom 3.0 format. The scan rate and spot size are adjusted depending on the film type to accurately capture either 5 or 10 line pairs per mm for standard and mammographic films, respectively.

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Performance Data:

Voluntary standards used in the design of the subject device(s) are:
UL1950		Safety of Information Technology Equipment
21 CFR1040		Laser Safety Standards
IEC825		Laser Safety Standards
EN60601-1-2 Class A		Electro-Magnetic Compatibility
EN55011	1991-97	Radiated and Conducted Immunity
EN55014-1	1993-97	Conducted Immunity
EN61000-4-2	1995	Electro-Static Discharge
EN61000-4-3	1996	Radiated Radio-frequency
ENV 50204	1995	Immunity to RF Telephone Emissions
EN61000-4-4	1995	Electronic Fast Transfer
EN61000-4-5	1995	Surge
EN61000-4-6	1996	Conducted immunity
EN61000-4-8	1993	Power Frequency Magnetic Field
EN61000-4-11	1994	Power Line Fluctuation

Conclusion:

The Imation™ Trimatic™ Digital Imaging System has no patient contact, does not control or monitor patient medical status. Digital images generated by the Trimatic Digital System are interpreted by competent medical practitioners, offering ample opportunity for competent human intervention where warranted.

Imation believes the subject device is safe and effective based on comparison to the predicate device, on prior clearance of devices incorporated in this system and by conformance to the above design standards.

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2017-02-04 11:12:13

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 1999

Stephen G. Slavens Regulatory Affairs Manager Imation Corp. 1 Imation Place Oakdale, MN 55128-3414

Re: K984252

Imation™ Trimatic™ Digital System Dated: November 25, 1998 Received: November 27, 1998 Regualtory class: II 21 CFR 892.2030/Procode: 90 LMA

Dear Mr. Slavens:

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 legally marketed predicate 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 (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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation 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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting 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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ATTACHMENT 2

Statement of Indications for Use:

510(K) Number (if known):	K984252
---------------------------	---------

Device Name: Imation™ Trimatic™ Digital System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109) OR

Over-the- Counter Use_

David C. Seaman

(Division Sign-Off) ovision of Reproductive, Abdominal, El ud Radiological Vk) Number

Regulation Number and Section

§ 892.2030 Medical image digitizer.

(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.