The Raven is a free standing device used to print diagnostic images for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

Device Description

The device accepts electrical image signals and produces hard copy images. The image signal source may be digital formatted image data from image readers or unformatted image data from other imaging modalities (e.g. CT, MRI). The image signal source may be analog or digital. The Helios Laser Imager uses the information in the image signals digitally record diagnostic images and patient data on a proprietary product specific medical imaging media. The Helios does not use conventional light-sensitive silver halide photographic media, requires no dark room, film processor, processing chemicals, water, drainage, or dryer ventilation. It produces no chemical waste, and requires no space for chemical storage.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Helios Laser Imager." This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving device performance against specific acceptance criteria for an AI algorithm. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in this document.

Here's an analysis based on the information provided, highlighting the differences in context:

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

The document describes modifications to an existing device (Helios Laser printer, K912073) and asserts that these modifications do not change the technology or safety of the Helios printer and that the new version ("Helios Laser Imager 1417") is without question substantially equivalent to its predecessor and is safe and effective for its intended use.

The "performance" described relates to the system's ability to accept image signals and produce hard copy images, and improvements in throughput and cost efficiency. However, there are no specific, quantifiable acceptance criteria or reported device performance metrics in the way one would expect for an AI algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, the closest to "criteria" are general statements about safety and equivalence.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Maintain Safety	"The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern..." "These modifications do not change the technology or safety of the Helios printer."
Maintain Effectiveness for Intended Use	"The Helios 'C' is without question substantially equivalent to its predecessor and is safe and effective for its intended use." "The device does not impact the quality or status of the original acquired image data."
Compatibility with Image Signals and Production of Hard Copy	"The device accepts electrical image signals and produces hard copy images." "The Helios Laser Imager uses the information in the image signals digitally record diagnostic images and patient data on a proprietary product specific medical imaging media." (No specific metrics on image quality are provided, but the statement implies successful image creation.)
Increased Throughput	"First is the increased number of lasers to allow the simultaneous printing of 2 lines of image data; thus increasing the throughput." (No specific numerical increase in throughput is provided, but the increase is stated.)
Improved Cost Efficiency and Reliability	"The mechanical sheet feeder has been improved for increased cost efficiency and reliability." (No specific metrics on cost reduction or reliability improvement are provided, but the improvement is stated.)
Compliance with Regulatory Standards	"The device complies with the relevant international and national Safety Standards. It has been manufactured in compliance with ISO9000 and the Quality System Regulation [21 CFR 820]." (This refers to general manufacturing and safety standards, not AI performance criteria.)

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

This document describes a hardware device modification, not an AI algorithm. Therefore, there is no concept of a "test set" of patient data for evaluating an AI's performance. The "testing" referred to would be internal engineering verification and validation of the hardware and software functionality, not medical image analysis performance.

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. As there's no AI algorithm being evaluated for diagnostic accuracy, there's no "ground truth" to establish from medical images or expert consensus. The function of the device is to print images accurately, not to interpret them. The document mentions that "The output of the device is evaluated by additional trained professionals allowing sufficient review to afford identification and intervention in the event of a malfunction," but this is about quality control of the printed output, not diagnostic ground truth.

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

Not applicable for the reasons mentioned above.

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 an imager, a hardware component for displaying medical images, not an AI-powered diagnostic tool. An MRMC study is not relevant here.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. There is no diagnostic ground truth established for this device, as its function is to print images, not to provide diagnostic interpretations.

8. The sample size for the training set:

Not applicable. This is a hardware device, not an AI algorithm requiring a training set of data.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Sterling Diagnostic Imaging. The word "STERLING" is in large, bold, sans-serif font, with the registered trademark symbol next to the "G". Below that, in a smaller font, are the words "Diagnostic Imaging". Above the logo is the number K973028 in a handwritten style.

OCT 28 1997

Summary of Safety and Effectiveness

Helios Laser Imager

CLASSIFICATION NAME:	Although this device has not been formally classified by FDA, it has been categorized as 90LMC and is regulated as Class II Tier I
COMMON/USUAL NAME:	Multi-Format Imager
TRADE/PROPRIETARY NAME:	Helios Laser Imager 1417
ESTABLISHMENT No.	1043882
PERFORMANCE STANDARDS:	The device complies with the relevant international

and national Safety Standards. It has been manufactured in compliance with ISO9000 and the Quality System Regulation [21 CFR 820].

SYSTEM DESCRIPTION:

More detailed information regarding the Helios can be found in the preliminary System Specification included in Section 2 as well as Section 4.

EQUIVALENCE INFORMATION:

This submission is for a modification of the previously cleared Helios Laser printer (K912073).

Sterling Diagnostic Imaging, Inc. 10 South Academy Street Mailbox 120 P.O. Box 19048 Greenville, SC 29602-9048

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August 11, 1997 Page - 2

There are two primary differences between the new version of the Helios, referred to as "C" during development, and its predecessor. First is the increased number of lasers to allow the simultaneous printing of 2 lines of image data; thus increasing the throughput. Secondly, the DICOM print server previously located external to the device has now been incorporated into the system.

to the aforementioned modifications, two non-significant addition In madifications are being incorporated into the "C" design. The mechanical sheet feeder has been improved for increased cost efficiency and reliability. The electronics modules have also been consolidated.

These modifications do not change the technology or safety of the Helios printer. The intended use and indications also remain unchanged. The Helios "C" is without question substantially equivalent to its predecessor and is safe and effective ffor its intended use.

SAFETY INFORMATION:

The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per the August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".

The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by additional trained professionals allowing sufficient review to afford identification and intervention in the event of a malfunction. The device does not impact the quality or status of the original acquired image data.

Sterling Diagnostic Imaging feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence within a reasonable time period. In the event that additional information is required, please contact the undersigned or Ms. Debra Hutson.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HU" are arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Timothy W. Capehart Manager of Regulatory Affairs and Compliance Sterling Diagnostic Imaging, Inc. 10 South Academy Street Mailbox 120 P.O. Box 19048 Greenville, SC 29602-9048

Re: K973028 Helios Laser Imager 1417 Dated: August 11, 1997 Received: August 14, 1997 Unclassified Procode: 90 LMC

OCT 2 8 1997

Dear Mr. Capehart:

We have reviewed your Section 510(k) notification of intent to market the device 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 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 probibitions 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 (OS) 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 begine your device as described in your 5100k) 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 (30) 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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K973028 510(k) Number (if known) :

Device Name :

Helios Laser Imager

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel li. Sypon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Deyi 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use ___________

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.