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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.

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.

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:

1. 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."
2. Sample Size for Test Set and Data Provenance: No information provided.
3. Number of Experts and Qualifications: Not mentioned.
4. Adjudication Method: Not mentioned.
5. 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.
6. 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.
7. 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.
8. Sample Size for Training Set: Not applicable as this is a hardware device, not a machine learning model.
9. 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

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.

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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.

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.

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.

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DIGITIZER DIRECTOR is a DICOM compatible software package which enables any medical facility personal computer (PC) with adequate memory and the appropriate film digitizer to perform secondary image capture of films using the Howtek film digitizer family. DIGITIZER DIRECTOR does not have any image compression capability. DIGITIZER DIRECTOR is an integrated DICOM network product which translates the images from proprietary digitizer format to DICOM format and sends them on to another DICOM application.

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 queries the designated DICOM 3.0 database as each patient record is created. Association is made with the patients already existing in the database. New patient information is required when no association is made. When patient information is complete, the entire patient record is sent to a designated DICOM entity, such as a database or viewing station. DIGITIZER DIRECTOR is a Microsoft Windows NT or Windows 95 based application.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DIGITIZER DIRECTOR device, structured as requested:

Device Name: DIGITIZER DIRECTOR

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics. The core of the submission revolves around demonstrating substantial equivalence to a predicate device (Star Technologies FISS) by matching functional characteristics.

Key Observation: The "acceptance criteria" are primarily based on functional equivalence to the predicate device and adherence to industry standards (DICOM 3.0, ISO 9001) for software development. There are no performance metrics like accuracy, sensitivity, specificity, or processing speed reported as one might find in AI/CAD substantial equivalence. This is characteristic of older 510(k) submissions for devices primarily focused on data conversion and transmission rather than diagnostic interpretation or complex image processing.

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

The document does not specify a numerical sample size for a "test set" in the context of typical algorithm validation. The validation described is more focused on software functionality and its ability to convert and transmit images, rather than evaluating diagnostic performance on a dataset of patient images.

• Sample Size: Not specified as a discrete number of cases or images.
• Data Provenance: Not specified. The testing described appears to be internal software validation rather than clinical data testing.

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

• Number of Experts: Not applicable/not specified.
• Qualifications of Experts: Not applicable/not specified.

This type of "ground truth" and expert review is typically associated with diagnostic algorithms that provide interpretative outputs. Since the DIGITIZER DIRECTOR's function is conversion and transmission, it does not generate diagnostic findings that would require expert-established ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

Similar to point 3, adjudication is not relevant for this type of software.

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

• MRMC Study: No.
• Effect Size: Not applicable.

The device is a teleradiology system for image capture, conversion, and transmission. It is not an AI/CAD device intended to assist human readers in making diagnoses. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Study: Yes, to the extent that it describes "Extensive testing of the software package has been performed by programmers, by nonprogrammers and by potential customers." This testing would have evaluated the software's ability to correctly perform its intended functions (image capture, DICOM conversion, transmission) independently, without a human actively interpreting the output in a diagnostic capacity. However, this is functional testing, not a diagnostic performance study.

7. Type of Ground Truth Used

The concept of "ground truth" in the diagnostic sense (e.g., pathology, longitudinal outcomes) is not applicable to this device. The "truth" for this device's validation is whether it correctly converts proprietary digitizer formats to DICOM 3.0 and transmits them without affecting image quality. This is a functional correctness truth, not a diagnostic truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not specified.

This device is not an AI/machine learning model that undergoes a training phase with a specific dataset. It is a software application designed for specific functional tasks.

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

• Ground Truth Establishment for Training Set: Not applicable.

As it's not an AI/ML model, there is no "training set" or ground truth established for training. The "truth" for software development would be based on functional specifications and DICOM 3.0 standards.

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The device is used in generating digital signals from medical radiographs. The digital signals are intended for use in PACS and tele-radiology.

The device is a transparency, charge coupled device (CCD) scanner which can be used to digitize radiographs or X-ray film. The digitizer reads gray digital information from the image and sends the raw data file to a host computer, for use with a Picture Archiving and Communication (PAC) System or teleradiology software package currently in the market place as separately approved third party software packages or complete PAC system. The user interface for the film digitizer resides in the host application software program. The 960 creates a digital image file from transparent originals. The digital image file is expressed in either 8 or 12 bit grav level file format. The digitizer is connected to a host computer (either PC, Mac or UNIX) via SCSI II. There is no "activate" button the 960. To start an image capture operation, the user must activate the digitizer user interface on the host computer. Overall, The 960 uses a film fed drive which transports the film over the camera as it digitizes the image. Each scan line is captured by the charge coupled device (CCD). The scan line of data is normalized and calibrated to align the response from individual CCD receptors. The image data signal is converted from analog to digital format on the OCP board. The digital signal is then sent to the host via the SCSI II connection with the host computer.

The provided text describes a 510(k) summary for the Howtek 960 Film Digitizer. It outlines the device's characteristics and states that performance testing was conducted. However, the document does not contain specific details about acceptance criteria or the study that proves the device meets those criteria.

Instead, it makes a general statement: "The performance testing results for the 960 Film Digitizer demonstrated that the device meets its intended specifications and therefore, meets the requirements necessary for its intended use as a component of a PAC system or teleradiology software package." It also highlights that the 960 is superior in some performance characteristics (scan rates, density range, gray scale resolution, spatial resolving power) compared to its predicate device, the Howtek Scanmaster DX.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
• Sample size used for the test set and the data provenance: This information is not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method: This information is not present.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The device is a film digitizer, not an AI-assisted diagnostic tool for human readers.
• Standalone performance: While the device is "standalone" in the sense that it digitizes films, the document does not present quantitative standalone performance metrics. It's a component, not an interpretative AI.
• Type of ground truth used: This information is not present.
• Sample size for the training set: This information is not present.
• How the ground truth for the training set was established: This information is not present.

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Ask a specific question about this device