The Imation™ SE-204 laser imager is intended use as a high resolution 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-204 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to Digital Radiography and full view digital mammography for diagnostic use by medical radiologists and communications to referring physicians and their patients.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Imation™ SE-204 Laser Imager, a hard copy device for medical imaging. The focus of this submission is on demonstrating substantial equivalence to predicate devices, rather than a detailed artificial intelligence (AI) performance study. As such, information regarding AI-specific acceptance criteria, study design, and performance metrics (like F1 score, effect size in MRMC studies, etc.) is not present in the provided document.

The document primarily discusses the device's technical characteristics, intended use, and its equivalence to predicate devices in terms of spatial resolution and safety standards.

Here's an analysis of the provided information based on your request, highlighting what is present and what is missing due to the nature of the device and the submission:

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

Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Spatial Resolution: Comparable to predicate devices, with slightly higher dpi for the SE-204.	"The subject and the predicate Agfa devices are similar with respect to spatial resolution with SE-204 pixels giving slightly higher dpi." Also, "The subject device has been designed to have similar resolution as the predicate Agfa LR 5200 Laser Film Recorder, which has the indications for use of full view digital mammography and high resolution computed radiography."
Safety and Effectiveness: Meeting voluntary standards and internal specifications.	"Safety and effectiveness are assured via meeting voluntary standards, including IEC601-1, IEC601-1-1, IEC601-1-2, UL2601 and Imation™ SE-204 Engineering specification(Part B)."
Image Quality Consistency: Assurance of consistent image quality between input signals and output density.	"As with this predicate device, a test pattern generator and automatic image quality control(AIOC) system are incorporated to assure consistency between input signals and output density."
Software Functionality: Successful conclusion of field and internal tests for qualification, validation, and reliability for final production release.	"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."
No Patient Contact: The device should not have patient contact.	"The subject device, like the predicates, has no patient contact."

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

Not Provided. The document describes internal and field tests but does not specify sample sizes for image data or the origin/nature of that data. Given the device is a laser imager, the "test set" would likely refer to images processed and printed.

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 / Not Provided. For a laser imager, "ground truth" would relate to the fidelity of image reproduction, not diagnostic accuracy. The document mentions "medical personnel" reviewing images, implying human oversight, but no specific experts or their qualifications for establishing ground truth for testing the imager are described.

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

Not Provided / Not Applicable. Adjudication methods are typically for diagnostic accuracy studies, which is not the primary focus of this device's submission.

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 reported.

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

Not Applicable. This device is a laser imager, not a diagnostic algorithm; thus, "standalone" AI performance is not relevant. The device's "AIQC (Automated Image Quality Control)" is part of its internal software function, ensuring consistent output, not making diagnostic decisions.

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

Implied Technical Ground Truth. For a laser imager, the "ground truth" for performance evaluation would generally be the fidelity of the printed image to the digital input signal, in terms of resolution, density, and freedom from artifacts. This is assessed through objective measurements and visual inspection against known test patterns and objective physical standards rather than clinical outcomes or diagnostic interpretations. The document mentions "test pattern generator" and "AIQC" to ensure consistency.

8. The sample size for the training set

Not Applicable / Not Provided. This is a hardware device with an internal quality control system (AIQC), not a machine learning model that requires a "training set" in the conventional sense for diagnostic tasks. The AIQC likely involves calibration and control mechanisms, not a learning algorithm trained on a dataset for prediction.

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

Not Applicable / Not Provided. As above, a "training set" in the AI sense is not specified. The "ground truth" for the AIQC system would be defined by engineering specifications for image quality and consistency.

Summary

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K972822 510(k) Summary NOV 1 9 1997

Magnetic Resonance Diagnostic Device

July 28, 1997

Imation Corp.		Contact: Stephen G. Slavens
1 Imation Place		3M Center, 235-2B-23
Oakdale MN 55128		St. Paul MN 55144-1000
		Phone: 612-736-9536
		FAX: 612-736-3116
Device: Trade name:	Imation™ SE-204 Laser Imager
Common name:	Laser Printer

3M(Imation™) 8300 Laser Imager(K936152) Predicate devices: Agfa LR 5200 Laser Film Recorder(K964414)

Description And Intended Use of Device:

Classification name:

21 CFR 892.1000

Technological Characteristics:

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Performance Data:

An important performance characteristics for medical hard copy devices is spatial resolution. The subject and the predicate Agfa devices are similar with respect to spatial resolution with SE-204 pixels giving slightly higher dpi.

Safety and effectiveness are assured via meeting voluntary standards, including IEC601-1, IEC601-1-1, IEC601-1-2, UL2601 and Imation™ SE-204 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 affect any devices directly connected to or affecting 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.

The subject and predicate device DryView™ Model 8300 have both been designed to the same safety standard. As with this predicate device, a test pattern generator and automatic image quality control(AIOC) system are incorporated to assure consistency between input signals and output density. The subject device has been designed to have similar resolution as the predicate Agfa LR 5200 Laser Film Recorder, which has the indications for use of full view digital mammography and high resolution computed radiography.

Imation therefore concludes that the Imation™ SE-204 Laser Imager is as safe and effective as the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH" are written on the left side of the logo, and the words "USA" are written on the top right side of the logo. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 19 1997

Steven G. Slavens Regulatory Affairs Manager Imation Enterprises Corporation 3M Center, Bldg. 235-2B-23 St. Paul, MN 551441000

Re:

K972822 Imation SE-204 Laser Imager Dated: October 18, 1997 Received: October 21, 1997 Regulatory class: 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 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.

h. William Yu, Ph.D.

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): ----------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: Imation™ SE-204 Laser Printer

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	✓
OR	Over the Counter Use ______
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K972522

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.