The Raven is a free standing device used to print diagnostic images on a polyester base for viewing on a standard view box and/or print reports and referral quality images on paper. 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 analog or digital formatted image data from image readers or unformatted image data from other imaging modalities (e.g. CT, MRI). The Sterling Raven Dry Imager uses the information in the image signals to control discrete elements in a print head which writes on the translating paper or Medical Imaging Film, a thermal recording media. The Raven has no laser, cathode ray tube, or optics. Like the predicate devices, the Raven does not use conventional light-sensitive silver halide photographic media, and thus 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.

The major elements are the film magazine, transport mechanics, imaging electronics, and head.

AI/ML Overview

The provided text, a 510(k) submission for the Sterling Raven Dry Imager, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a formal study with defined acceptance criteria and performance results in the manner typically seen for new diagnostic algorithms.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) that a study would aim to meet for a new diagnostic device. Instead, the "acceptance criteria" are implicitly focused on the functional equivalence and safety compared to predicate devices. The reported "performance" is primarily a description of the device's capabilities and its similarity to existing, cleared devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence:
- Produces hard copy images from medical image data	- Accepts electrical image signals and produces hard copy images. Image signal source may be analog or digital formatted from image readers or unformatted from other modalities (e.g., CT, MRI).
- Produces monochrome (black-and-white) gray-scale images	- Subject device produces monochrome (black-and-white) gray-scale images from medical image data.
- Uses thermal recording media	- Uses coated 7mil sheet film and/or paper (polyester) for recording the image, a thermal recording media.
- Does not require chemicals/darkroom	- Requires no dark room, film processor, processing chemicals, water, drainage, or dryer ventilation. Produces no chemical waste, requires no space for chemical storage.
- Software functionality for interfacing and control	- Software component for interfacing to image data and controlling hardware during printing is equivalent to the software used in predicate devices.
Safety and Effectiveness Equivalence:
- No patient contact	- Has no patient contact.
- Does not control, monitor, or affect patient-contacting devices	- Does not control, monitor, or affect any devices directly connected to or affecting such a patient-contacting device.
- Allows for human intervention in case of failure	- Images generated by the subject device are observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.
- Performance similar to predicate devices	- While technologically different (ink deposition vs. laser), the performance of the subject device is similar to that of the predicate. Conclusion: "the subject devices are as safe and effective as the predicate device." The Raven can print diagnostic images on a polyester base for viewing on a standard view box.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not mention a specific "test set" or a sample size of medical images used for a performance study. This is expected given the nature of a 510(k) for an imager rather than a diagnostic algorithm. The assessment is based on the device's mechanical and output characteristics, and comparison to existing technology.
Data Provenance: Not applicable, as no image-based test set is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts/Qualifications: Not applicable. There is no mention of experts establishing ground truth for a test set of images. The "ground truth" for this device likely revolves around objective physical properties of the printed image (e.g., density, resolution, uniformity) which would be assessed using measurement tools and visual inspection by engineers/quality control, rather than clinical experts.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable, as no test set requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. The text does not mention an MRMC study. The device is a "dry imager," meaning it generates physical prints. The focus is on the quality of these prints being comparable to those from predicate imagers, not on improving human reader performance with AI assistance. There is no AI component mentioned in the context of diagnostic interpretation.
Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

Standalone Study: No. The Sterling Raven Dry Imager is a hardware device for printing images, not a diagnostic algorithm. Its performance is intrinsically linked to the physical output. While it has a software component for interfacing and control, this software itself is stated to be "equivalent to the software used in the predicate devices," suggesting no novel algorithmic performance study was needed or performed.

7. Type of Ground Truth Used:

Type of Ground Truth: For a device like an imager, the "ground truth" would be related to the physical characteristics of the printed output compared to the input digital image, and against the performance of predicate devices. This would likely involve:
- Objective physical measurements: Densitometry (for gray-scale accuracy), spatial resolution tests (line pairs per mm), modulation transfer function (MTF), uniformity measurements.
- Visual comparison: Comparing printed images from the Raven to those from predicate devices or reference prints for fidelity, contrast, and overall diagnostic quality when viewed by trained personnel.
- Functional validation: Ensuring all interfaces work correctly and the device reliably prints without error.
The document implies that these types of characteristics were assessed to deem the "performance... similar to that of the predicate."

8. Sample Size for the Training Set:

Sample Size: Not applicable. The Sterling Raven Dry Imager is a printing device, not a machine learning model, so there is no "training set" in the context of AI development. The device's operation is based on established engineering principles and thermal printing technology.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment: Not applicable, as there is no training set.

Summary

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Summary of Safety and Effectiveness

Trade Name, Common Name, Classification

NOV 1 0 1997 972660

The device trade name is Sterling Raven Dry Imager. The device common names is medical image printer. While officially unclassified, the predicates are assigned to regulatory classification II and are categorized as Multi-Format Cameras, 90LMC.

Predicate Device

Sterling identifies the predicate devices as the Sterling Lynx LP400 Laser Imager (K912073 August 28, 1991) and the 3M Dry View 8700 Laser Imager. FDA's accession number for the Premarket notification for the predicate devices are K912073 and K945475 respectively. FDA cleared the marketing of the predicate devices in letters dated August 28, 1991 and March 9, 1995.

The primary differences between the devices is that the Raven will deposit ink onto the printing surface while the predicate utilizes a laser print head to affect a film coating or a laser to expose silver halide film.

The software component of the Raven is used for interfacing to the image data as well as controlling hardware components during the actual printing process. Software utilized within the Raven is equivalent to the software used in the predicate devices.

Description of the Device

The major elements are the film magazine, transport mechanics, imaging electronics, and head.

Intended Use

The intended use of the Imager is the production of hard copy images from medical image data

Technological Characteristics

The subject device, as the predicate, produces monochrome (black-and-white) gray-scale images from medical image data. The media and the technological characteristics are different from routine laser printers. The Raven device uses coated 7mil sheet film and/or paper for recording the image.

The predicate devices expose the film by translating it past a directly modulated scanning laser diode source. The action of the laser causes the image to be recorded in the media. The Raven print head differs from the predicates' in that it physically places the black dye onto the medium rather than attempting to modulate an intermediate medium.

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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 Sterling Raven Dry Printer uses the information in the image signals to control discrete elements in a print head which writes on translating paper or Medical Imaging Media (polyester). The Raven has no laser, cathode ray tube, or optics. The Raven 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.

The major elements of the Printer are the film magazine, transport mechanics, imaging electronics, and print head.

Conclusion [21 CFR: 807.92(b)(3)]

As the predicates, the subject device has no patient contact, nor does it control, monitor, or effect any devices directly connected to or effecting such a patient contacting device. The images generated by the subject device is observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.

While technologically different, the performance of the subject device is similar to that of the predicate, we conclude that the subject devices are as safe and effective as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 10 1997

Timothy W. Capehart Manager of .Regulatory Affairs and Compliance Sterling Diagnostic Imaging Inc. P.O. Box 6101 Building 600/Mailbox 630 Newark, DE 197146101

Dear Mr. Capehart:

K972660 Raven Dry Printer Dated: October 21, 1997 Received: October 23, 1997 Regulatory class: Unclassified 21 CFR 892.1670/Procode: 90 LMC

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 inclosure) to devices marked in interstate commence 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 OS 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 vitro 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.

William 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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510(k) Number (if known) :

Device Name :

Raven Dry Imager

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NÉEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinit L. Aggarwal

(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 4972660 510(k) Number .

Prescription Use
(Per 21 CFR 801.109)

ﺴﻌ

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.