The Imation™ SE-196 laser imager is intended use as a high quality hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.

Device Description

The Imation SE-196 Laser Imager provides high quality hard copy film output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Imation™ SE-196 Laser Imager, formatted to address your specific questions.

It's important to note that the provided document is a 510(k) summary from 1997 for a laser imager, not a modern AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this type of submission for this particular device. The "Performance Data" section discusses traditional imaging characteristics rather than AI algorithm performance.

Acceptance Criteria and Study for Imation™ SE-196 Laser Imager (K972163)

The device described is a laser imager, which is a physical device for printing medical images. Its performance criteria are related to image quality reproduction, not diagnostic accuracy of an AI algorithm.

1. Table of Acceptance Criteria

Acceptance Criterion	Reported Device Performance
Spatial Frequency Response (DPI)	- Subject Device (Imation™ SE-196): 325 dpi (pixel size) - Predicate Devices: 325 dpi (pixel size) Similar to predicate devices.
Gray Scale Resolution	- Subject Device (Imation™ SE-196): 12 bit - Predicate Devices: 8 or 12 bit Equivalent to or better than predicate devices (only 12 bit, which is the higher end of predicate). Image properties are "same or better".
Density Uniformity	- Subject Device (Imation™ SE-196): Same or better than predicate devices. - Mechanism: Built-in density test patterns and AIQC (Automatic Image Quality Control) that maintains density uniformity over time and changes in film media. Image properties are "same or better".
Safety (Voluntary Standards Compliance)	- UL544 - IEC601-1 - IEC 825 - Imation™ SE-196 Engineering Specification (Part B) - Predicate Devices: Designed to UL1950. Subject device designed to UL1950 (same as predicate) and other applicable standards.
Reliability, Qualification, Validation	- Successfully concluded field test. - Successfully concluded internal tests for qualification, validation, and reliability. No specific numerical performance metric is given for these, but successful conclusion is stated as the criteria for final release.
AIQC (Automated Image Quality Control)	- Matches printing power with film characteristics to provide consistently high image quality. - Assure consistency between input signals and output density. This is a feature that contributes to image quality (density uniformity) and is incorporated in both subject and predicate devices.

Study Details:

The document describes "field tests and internal tests for qualification, validation and reliability." However, it does not provide detailed information about these studies in the context of AI/ML device evaluations. This is a traditional medical device submission, focusing on equivalence to predicate devices based on technological characteristics and functional performance related to image output quality.

2. Sample size used for the test set and the data provenance:

Not applicable / Not specified for an AI algorithm. This document describes a laser imager, a hardware device for printing images. The "performance data" refers to characteristics of the printed output, not a diagnostic algorithm's performance on a dataset of patient images.
The "field test" and "internal tests" would likely involve evaluating printed films, but the specific methodologies, sample sizes (of films or images), or data provenance (country, retrospective/prospective) are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The device is an imager, not a diagnostic AI tool. Ground truth in the context of an AI algorithm's diagnostic performance is not relevant here. The evaluation involves technical image properties, possibly assessed by engineering or quality control personnel against specifications.
Medical personnel review the images displayed by the device, and their "competent human intervention" is mentioned as a safety mechanism, but not as part of establishing a ground truth for a diagnostic algorithm.

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

Not applicable. This concept of adjudication is specific to evaluating diagnostic AI algorithms where expert consensus is needed to establish ground truth for ambiguous cases. It is not relevant to a laser imager's performance evaluation as 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:

No. This is not an AI-assisted diagnostic device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or would be relevant.

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

Not applicable. This device is a laser imager. It does not contain a standalone AI algorithm for diagnostic interpretation. Its "AIQC" is an Automated Image Quality Control system, managing printing power and film characteristics, not a diagnostic AI.

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

For the reported performance characteristics (spatial frequency response, gray scale resolution, density uniformity), the "ground truth" would be established through technical specifications, calibrated measurement tools, and industry standards for image quality. For example, dpi is measured directly, and gray scale is a technical specification of the digital-to-analog converter and laser modulation. Density uniformity would be measured using a densitometer against a calibrated test pattern. This is not medical ground truth like pathology or expert consensus.

8. The sample size for the training set:

Not applicable. The device is a laser imager, not an AI/ML algorithm that requires a training set of medical images. The "AIQC" system is likely rule-based or uses internal calibration data, not a "training set" in the context of deep learning.

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

Not applicable. As there is no AI/ML training set in the modern sense, the concept of establishing ground truth for it does not apply.

Summary

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510(k) Summary

K972163 SEP - 5 1997

June 1, 1997

Imation Corp. 1 Imation Place Oakdale MN 55128 Contact: Stephen G. Slavens 3M Center, 235-2B-23 St. Paul MN 55144-1000

Phone: 612-736-9536 FAX: 612-736-3116

Device:
Trade name:	Imation TM SE-196 Laser Imager
Common name:	Laser Printer
Classification name:	Magnetic Resonance Diagnostic Device21 CFR 892.1000

3M(Imation™) 8700 Laser Imager Predicate devices:

Description And Intended Use of Device:

Technological Characteristics:

The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. Modality data and printing functions are performed by the IMS(Image management System). User control is performed by a keypad or directly by the modality through the host control. Imation imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and exits the printer.

Software is used to control the image management and machine functions. AIQC(Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.

Performance Data:

Important performance characteristics for medical hard copy devices are spatial frequency response, gray scale resolution and density information. The subject and predicate devices are similar with respect to spatial frequency response with pixel size of both devices being 325 dpi. Gray scale resolution for the predicate is wither 8 or 12

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bit and 12 bit only for the subject device. Density uniformity of the subject device is the same or better than the predicate devices have built in density test patterns and AIQC (Automatic Image Quality Control) that maintains density uniformity over time and over changes in the film media.

Safety and effectiveness are key activities in the commercialization and are assured via meeting voluntary standards, including UL544, IEC601-1, IEC 825 and Imation™ SE-196 Engineering specification(Part B).

With the successful conclusion of both the field test and internal tests for qualification, validation and reliability, the Product Team will approve final release for production (including Software). After final approval, according to the established procedures, the software code label will be changed to production level label.

Conclusion:

The subject device, like the predicates, has no patient contact. The devices also do not control, monitor or otherwise effect any devices directly connected to or effecting the patient. Images displayed by the subject device and its predicates are reviewed by medical personnel, offering ample opportunity for competent human intervention in case of a malfunction or other failure.

Films imaged by the subject device display the same or better image properties in the areas of spatial and gray-scale resolution and in density uniformity as the predicate. As with the predicate devices, a test pattern generator and automatic image quality control(AIQC) system are incorporated to assure consistency between input signals and output density.

The subject and predicate device(s) have all been designed to the same safety standard, UL1950.

Imation therefore concludes that the Imation™ SE-196 Laser Imager is as safe and effective as the predicate device

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Image /page/2/Picture/0 description: The image shows a black and white logo for the Department of Health. The logo features a stylized bird-like symbol with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the symbol, with the letters oriented to be read from top to bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stephen G. Slavens Regulatory Affairs Imation Corp. 1 Imation Place Oakdale, MN 55128-3414 SEP - 5 1997

Re: K972163

Imation™ SE-196 Laser Imager Dated: June 1, 1997 Received: June 9, 1997 Unclassified : Procode: 90 LMC

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 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 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 yitro 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

htliau Yin

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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ATTACHMENT 2

Statement of Indications for Use:

510(K) Number (if known): K972163

Device Name: Imation™ SE-196 Laser Printer

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use × (Per 21 CFR 801.109)

Over the Counter Use

Vorris C. klairr

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

Regulation Number and Section

§ 892.2040 Medical image hardcopy device.

(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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.