The Howtek Fulcrum Family consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Fulcrum is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications.

The Fulcrum Family does not include applications specific software (Picture Archiving and Communications (PAC) system, Teleradiology, or Computer Aided Detection (CAD) software). The manufacturer of the application software will determine specific indications for use. These third-party software packages or complete PAC systems are approved separately.

Device Description

The device is a transparency film digitizer and paper, charge coupled device (CCD) digitizer that can be used to digitize radiographs or paper reports. The digitizer reads digital gray scale information for each pixel deposits the raw data in the computer. The user interface for the digitizer resides in the applications software. There is no activate button on the digitizer. The activate button is provided trough the digitizer user interface which is part of the third party software package.

Overall the Fulcrum uses a drive, which transport the paper or film over the camera as it digitizes the image. Each scan line is captured by the chargecoupled device (CCD). The scan line of data is normalized and calibrated to align the response from each individual pixel. The image data signal is converted from analog to digital format by and A to D converter. The Fulcrum creates a digital image in either 16-bit, 12-bit or 8-bit raw format. The information is transmitted to the computer via USB II.

AI/ML Overview

The provided text is related to the 510(k) premarket notification for the "Howtek Fulcrum Family" film digitizer. However, it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a detailed study description.

Here's a breakdown of what can be extracted and what is missing:

What can be extracted/inferred:

Device Type: Film Digitizer
Purpose: Digitize radiographs/X-ray film and paper reports.
Intended Use for Radiographs: Primary, secondary, and over-reading applications.
Comparison: To a predicate device, the Howtek MultiRAD.
Claimed Performance: The Fulcrum is a "superior product" with "the same or better range and resolution" than the MultiRAD.
Study Existence: "The performance testing results for the Fulcrum demonstrated that the device meets its intended use specifications..."

What is missing entirely or in detail:

Detailed Acceptance Criteria Table: The document states that performance testing demonstrated that the device meets its intended use specifications, but it does not list these specifications (e.g., specific thresholds for resolution, density range, gray scale resolution, signal-to-noise ratio, etc.) nor provide the quantitative "reported device performance." It only uses qualitative comparative terms like "better" or "same or better."
Sample Size for Test Set and Data Provenance: No information provided.
Number of Experts and Qualifications: Not mentioned.
Adjudication Method: Not mentioned.
MRMC Comparative Effectiveness Study: Not mentioned, and highly unlikely for a film digitizer from this era. This type of study is more common for diagnostic AI algorithms directly impacting human reader performance. This device is a component.
Standalone Performance: While the document implies standalone performance testing of the digitizer's characteristics (resolution, density range), it doesn't present it as a formal "standalone study" in the context of an AI algorithm's diagnostic accuracy. It's a performance evaluation of the hardware's output.
Type of Ground Truth: Not specified for any performance testing. For a digitizer, ground truth would likely be based on objective physical measurements of the film and its digital representation, rather than medical outcomes or pathology.
Sample Size for Training Set: Not applicable as this is a hardware device, not a machine learning model.
How Ground Truth for Training Set was Established: Not applicable.

Based on the provided text, here is what can be filled out, with explicit notes about missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Conceptual)	Reported Device Performance
Specific quantitative thresholds for density range, gray scale resolution, spatial resolving power, scan rates.	"The Fulcrum family has the same or better range and resolution as the MultiRAD family."
Meets intended use specifications.	"The performance testing results for the Fulcrum demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use..."
Equivalent or superior performance to predicate device (Howtek MultiRAD).	"The Fulcrum is a superior product." "The Fulcrum is more than capable of providing equivalent performance than the MultiRAD."
Specific quantitative thresholds for various image quality metrics after digitization.	No specific quantitative metrics reported in the document.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified. (The document describes general "performance testing" but does not detail the dataset used for such testing.)

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

Not applicable/Not specified. The ground truth for evaluating a digitizer would likely involve objective physical measurements rather than expert interpretations of digitized images, as the device's role is to accurately convert analog to digital.

4. Adjudication method for the test set

Not applicable/Not specified.

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. An MRMC comparative effectiveness study was not conducted or mentioned. This type of study is relevant for AI algorithms that assist human interpretation, not for a standalone film digitizer. The device itself "does not include applications specific software (Picture Archiving and Communications (PAC) system, Teleradiology, or Computer Aided Detection (CAD) software)."

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

Yes, performance testing of the digitizer's characteristics (scan rates, density range, gray scale resolution, spatial resolving power) was implicitly done in "standalone" mode, as it's a hardware device. However, the exact methodology and quantitative results of this "performance testing" are not detailed in the provided text. The document states, "The performance testing results for the Fulcrum demonstrated that the device meets its intended use specifications."

7. The type of ground truth used

Inferred: For a film digitizer, the "ground truth" for performance testing would typically involve objective measurements of the original physical film characteristics (e.g., known optical density ranges, resolution patterns) and comparing them to the fidelity and accuracy of the digitized output. The document itself does not explicitly state the ground truth methodology.

8. The sample size for the training set

Not applicable. This device is a hardware film digitizer, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable.

Summary

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KOZ 1949

Image /page/0/Picture/1 description: The image shows the logo for Howtek. The logo features the word "Howtek" in a bold, sans-serif font, with the letters slightly spaced apart. To the right of the word is a graphic of a tornado or swirling cloud. The logo is simple and modern, with a clear and recognizable design.

AUG 1 2 2002

FOI 510(k) Summary

In conformance with Section 543(t)(3) of the Food, Drug, and Cosmetic Act, Howtek Incorporated hereby submits with this Premarket Notification an adequate summary of any information on safety and effectiveness.

Submission Date:	June 12, 2002
Owner/Operator:	Howtek Incorporated21 Park AvenueHudson, NH 03051
Device Common /Usual Trade Name:	Film Digitizer
Device Trade Name:	Fulcrum
Classification Name:	Digitizer, Film (90LMA)Class IITeleradiology DevicePAC Peripheral Device
Predicate or LegallyMarketed Devices:	Howtek MultiRAD, Film Digitizer

Description of Device:

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image in either 16-bit, 12-bit or 8-bit raw format. The information is transmitted to the computer via USB II.

Indications for Use:

The Fulcrum does not include applications specific software (Picture Archiving and Communications (PAC) system, Teleradiology, or Computer Aided Detection (CAD) software). The manufacturer of the application software will determine specific indications for use. These third-party software packages or complete PAC systems are approved separately.

Contraindications:

The Fulcrum will be marketed as a component to applications software development companies, who will incorporate the Fulcrum into their respective PAC or Teleradiology system. The software developer will be responsible for detailing the Contraindications for the PAC System (or Teleradiology software package) as a whole, including the Fulcrum.

Potential Complications:

The Fulcrum will be marketed as a component to applications software development companies, who will incorporate the Fulcrum into their respective PAC or Teleradiology system. The software developer will be responsible for detailing the Potential Complications for the PAC System (or Teleradiology software package) as a whole, including the Fulcrum.

Technological Characteristics or Proposed and Predicate Device:

The proposed Fulcrum has the same basic characteristics as the predicate Howtek MultiRAD. The MultiRAD was designed to digitize X-ray film or radiographs. In addition, the predicate device operates at lower scan rates, less density range, less gray scale resolution and less spatial resolving power. The Fulcrum is a superior product.

Performance Characteristics:

The performance testing results for the Fulcrum demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use as a component of a PAC or Teleradiology system.

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Conclusion:

Based on the information presented in this Premarket Notification. Howtek Incorporated believes that the proposed Fulcrum Family of film digitizers is substantially equivalent to the Howtek MultiRAD Family of film digitizers. The Fulcrum family is equivalent to the predicate film digitizer in regard to its intended use (i.e. it captures X-ray films or radiographs as part of a PAC system or Teleradiology software package). The technological characteristics are substantially equivalent in that thev are both CCD based film digitizers. The performance characteristics show that the Fulcrum family has the same or better range and resolution as the MultiRAD family. Therefore, the Fulcrum is more than capable of providing equivalent performance than the MultiRAD.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

Mr. W. Scott Parr CEO Howtek, Inc. 21 Park Avenue HUDSON NH 03051 Re: K021949 Trade/Device Name: Fulcrum Family Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: June 12, 2002 Received: June 13, 2002

Dear Mr. Parr:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdin

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko 2 1949

Image /page/5/Picture/1 description: The image shows the logo for Howtek. The logo consists of the word "Howtek" in a bold, sans-serif font, with a stylized image of a tornado or swirling cloud above and to the right of the word. The letters are black, and the tornado image is also black. There is a trademark symbol to the right of the word.

Indications for Use

Prescription Use

David A. Lyon

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number

Howtek, Inc. Company Confidential

Regulation Number and Section

§ 892.2030 Medical image digitizer.

(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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.