The intended use of DIGITIZER DIRECTOR: Image Compression Module is as a DICOM image compressor that will enable any hospital or medical facility PC with adequate memory and the appropriate film digitizer to send images to other DICOM entities such as viewing stations and databases in an efficient manner. The compression algorithms used are fully supported by the DICOM 3.0 Standard.

Device Description

DIGITIZER DIRECTOR: Image Compression Module is an expansion module to Digitizer Director. The module provides a compression solution which uses compression algorithms which are fully supported by DICOM. Digitizer Director is a DICOM 3.0 compliant secondary image capture application for the Howtek family of film digitizers, It is a query / retrieve service class provider (QRSCP). DIGITIZER DIRECTOR and the Image Compression Module are Microsoft Windows NT or Windows 95 based applications.

AI/ML Overview

This document describes a Teleradiology System, specifically an "Image Compression Module" for the Digitizer Director. The submission primarily focuses on the device's functionality as a DICOM image compressor and its substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific, quantifiable acceptance criteria such as performance metrics (e.g., compression ratio, image quality preservation thresholds, speed targets for compression/decompression).

Instead, the "Validation of Effectiveness" section states: "Extensive testing of the software package has been performed by programmers, by nonprogrammers and by potential customers."
And also, under "Summary Statement of Safety and Effectiveness," it notes: "Software is only used for control purposes and has no bearing on image quality. There is no image processing or compression used with this software." (This contradicts the device name and intended use, which clearly state it's an "Image Compression Module" that uses "compression algorithms").

Given the contradiction and lack of specific performance metrics, it's impossible to create a table of acceptance criteria and reported device performance as requested. The device is being cleared based on its function as a DICOM image compressor that is fully supported by the DICOM 3.0 Standard, and its substantial equivalence to a predicate device (Applicare RadWorks) that also uses JPEG compression in DICOM format. The key "performance" claimed is compliance with DICOM 3.0 and the use of supported compression algorithms.

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

Sample Size for Test Set: Not specified. The document vaguely mentions "Extensive testing" and "nonprogrammers and by potential customers" but provides no numbers of images, cases, or users.
Data Provenance: Not specified. There is no mention of the country of origin of the data or whether it was retrospective or prospective.

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

Number of Experts: Not specified. The document mentions "nonprogrammers and by potential customers" but does not define them as "experts" in the clinical sense, nor does it quantify how many were involved or their qualifications. Given the device's function as a compression module, clinical experts might not have been deemed necessary if the claim was simply about adherence to standards and not about diagnostic accuracy.
Qualifications of Experts: Not specified.

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

Not specified. No adjudication method is mentioned.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported. This device is an image compression module, not an AI diagnostic tool.
Effect Size: Not applicable.

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

Standalone Performance: The documentation implies a form of standalone performance was assessed in terms of software functionality and DICOM compliance. The statement "Software is only used for control purposes and has no bearing on image quality. There is no image processing or compression used with this software" is highly contradictory to the device's name and intended use, which is an "Image Compression Module" that uses "compression algorithms." If we assume the intended meaning, the "testing of the software package" by programmers and non-programmers implies evaluating the compression algorithms' functionality (e.g., successful compression and decompression, compliance with DICOM JPEG) without human interpretation of the compressed images for diagnostic purposes. However, no specific metrics or studies for this standalone performance (e.g., compression ratio, fidelity) are provided.

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

Ground Truth: Given the nature of the device as a compression module, the "ground truth" likely related to the technical correctness of the compression and DICOM compliance, rather than clinical ground truth (e.g., disease presence). For example, a successful compression and decompression resulting in an image that is still DICOM compliant and visually/digitally consistent with the original would be the "ground truth" for its function. However, the specific methodology for establishing this is not detailed.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This document describes a software module for image compression, not a machine learning or AI model that requires a "training set." The software uses established JPEG compression algorithms supported by DICOM.

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

Ground Truth for Training Set: Not applicable, as no training set for a machine learning model is mentioned.

Summary

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FOI 510(k) Summary

K973081

In conformance with Section 513(l)(3) of the Food, Drug, and Cosmetic Act, Howtek Incorporated hereby submits with this Premarket Notification an adequate summary of any information.

1.1 Submission Date:	August 6, 1997	NOV - 5 1997
1.2 Owner / Operator:	Howtek Incorporated21 Park AvenueHudson, New Hampshire 03051
1.3 Official Correspondent:	M. Russell LeonardChief Operating Officer
1.3 Device Common / Usual Name:	Teleradiology System
1.4 Device Trade Name:	DIGITIZER DIRECTOR: Image Compression Module
1.5 Classification Name:	PACSClass IITeleradiology DevicePAC Peripheral Device
1.6 Predicate or LegallyMarketed Devices:	Applicare, BVIRadWorks#K962699

1.7 Describilion of Device:

. .

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1.8 Intended Use:

1.9 Software Development

Howtek certifies that the DIGITIZER DIRECTOR: Image Compression Module software is designed, developed, tested and verified according to ISO 9001 procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software used in this product is used for teleradiology and / or image storage only and does not effect image quality.

2.0 Statement of Substantial Equivalence

Function of Variable	HowtekDIGITIZER DIRECTOR	ApplicareRadWorks
Input	Digital Image from raw data	Digital Image from raw data
Function Performed	Conversion to DICOM 3.0Format	Conversion to DICOM 3.0Format
Output	Sent image to specifiedDICOM application	Sent image to specifiedDICOM application
Store and Forward Option	Yes	Yes
Image buffering duringNetwork Downtime	Yes	Yes
JPEG Compression	Yes	Yes

Substantial Equivalence Chart (DIGITIZER DIRECTOR)

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Summary Statement of Safety and Effectiveness

In accordance with the provisions of the Safe Medical Device Act of 1990, Howtek, Inc. provides this summary of safety and effectiveness information regarding DIGITIZER DIRECTOR.

1.1 General Safety and Effectiveness

The device labeling contains instructions for use and indications for use.

The hardware components specified ( but not supplied) are all off-the-shelf computer components.

1.2 Validation of Effectiveness

Extensive testing of the software package has been performed by programmers, by nonprogrammers and by potential customers. Software is only used for control purposes and has no bearing on image quality. There is no image processing or compression used with this software.

1.3 Substantial Equivalence

Howtek's DIGITIZER DIRECTOR: Image Compression Module is used to compress secondary capture images in DICOM JPEG format. RadWorks uses IJG JEPG as well and sends the image in DICOM format. Any differences between the device and the predicate device have no significant influence on the safety or effectiveness of the product.

It is our conclusion that there is no software component that we know of in the Howtek DIGITIZER DIRECTOR: Image Ocmoression Module Application whose failure or latent system design flaw would be expect on the within thath or injury to trip sich ti

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized representation of human figures, with three abstract profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1997

M. Russell Leonard Chief Operating Officer Howtek, Inc. 21 Park Ave. Hudson, NH 03051

Re:

K973081 Digitizer Director: Image Compression Module -H04059 - Rev 2.0 Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Mr. Leonard:

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, 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 (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 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.

W. Liao 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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Attachment C Indications For Use Statement

510(k) Number(if Known): イクフ 3つ8/

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinnit A. Grayson

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices

510(k) Number K973081

Prescription Use:X

ﺎ .

Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(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).