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DI-2000 is intended to utilize a scanner and software interface to digitize either radiology film or computed radiography exposed phosphor plates.

DI-2000 is a DICOM 3.0 compliant radiological digitization application.

DI-2000 enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class.

Supports scanning of films or phosphor plates in batch mode prior to entering patient information. Once scanned, images can be sent to multiple destinations.

A detailed description of each of all functions is contained in the Functional Requirements Specification, included as Appendix B. The following feature comparison provides an easy way to identify the changes between the initial 510(k) for DICOM Client submitted December 1995, and this addendum for DI-2000.

The provided document is a 510(k) Summary for a medical device (DI-2000 DICOM Client) submitted in 1998. It details the device's features, comparisons to equivalent devices, and information regarding safety and effectiveness. However, it does not explicitly contain a study designed to prove specific acceptance criteria with reported device performance metrics in the way a modern clinical or performance study report might.

Instead, the document primarily focuses on establishing substantial equivalence to legally marketed predicate devices and outlining the software's functionality and hazard analysis. The "Test Data and Conclusions" section refers to "Appendix B," which is not provided in the input, but based on the context of a 510(k) submission from 1998 for PACS components (which are considered accessories to medical imaging devices), it is highly unlikely to contain a multi-reader, multi-case study with human readers or detailed standalone algorithm performance.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Based on the provided text, specific, quantitative acceptance criteria with corresponding performance metrics are not explicitly stated or presented in a table format. The document describes the device's features and its compliance with standards, implying that meeting these features and standards constitutes "acceptance."

The key "performance" aspect discussed is related to image compression, specifically Wavelet compression. The document describes the technical methodology of Wavelet compression, its mathematical underpinnings, and asserts that it can achieve "no appreciable effect on image quality" when performing lossless compression. It also states that "After an image has undergone a wavelet transform, an effort is made to detect those regions of the transform which have little or no contrast. Once such a region has been identified, it is quantized (stored with fewer bits of precision than those parts of the transform which appear important). It is in the quantization steps that all loss occurs. Once quantization is performed, it is not possible to retrieve the original, higher presentation." This describes the mechanism of lossy compression and implies a trade-off between compression ratio and original image fidelity.

Given the absence of a direct table, I can infer some "acceptance criteria" from the product's features and standards, and the "reported device performance" as implied functionalities:

Study Information (Based on Available Text):

The document does not describe a detailed scientific study with specific performance metrics such as accuracy, sensitivity, or specificity. Instead, it seems to rely on:

• Hazard Analysis: To identify, evaluate, and mitigate risks.
• Feature Comparison: Demonstrating equivalence to predicate devices based on shared and improved features.
• Compliance with Standards: Adherence to established industry and regulatory standards.
• Assertions of Functionality: Stating what the software "can do" or "supports."

Here's an breakdown based on your requested points, highlighting what is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: As detailed above, explicit quantitative criteria and performance results in a table are not provided. The "acceptance criteria" are inferred from the stated functionalities and compliance needs.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The document mentions "Test Data and Conclusions" are in Appendix B (which is missing). However, the general tone of the document, focusing on software features and DICOM compliance for a PACS component, suggests that "test data" would likely pertain to functional testing and adherence to DICOM standards rather than clinical image-based performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. This information is typically found in studies evaluating image interpretation or diagnostic accuracy, which is not the primary focus of this submission for a DICOM client software.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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 study was not done or described. This type of study is associated with AI-powered diagnostic aids, which is not what the DI-2000 DICOM Client (a PACS component for digitization and transfer) is.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study (in a diagnostic sense) was not done or described. The "Image Processing Algorithm" feature mentioned would likely refer to general image display adjustments rather than a diagnostic algorithm. The primary "algorithm" discussed is image compression (JPEG and Wavelet), where the performance is described in terms of its technical mechanism and effect on image size and, anecdotally, "no appreciable effect on image quality" for lossless compression.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. As there's no mention of a diagnostic performance study, there's no ground truth explicitly defined for such a purpose. For functional testing, the "ground truth" would be the expected behavior of the software according to its design specifications and DICOM standards.

8. The sample size for the training set: Not applicable/Not specified. This device is a DICOM client software, not an AI/Machine Learning model that would require a "training set" in the conventional sense of pattern recognition or diagnostic algorithms. Its development would involve software engineering and testing.

9. How the ground truth for the training set was established: Not applicable/Not specified. See point 8.

Conclusion:

The provided 510(k) summary for the DI-2000 DICOM Client focuses on demonstrating substantial equivalence through feature comparison, adherence to standards, and a hazard analysis for a software accessory to medical imaging systems. It does not present a detailed clinical or performance study with quantified acceptance criteria and measured device performance metrics in the way modern AI/CADx devices often do. The "Test Data and Conclusions" are referred to an Appendix (B) which is not available, but given the nature of the device and the submission date (1998), it's highly improbable that it would contain the type of study details requested.

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