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The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use.

The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use. The system is based on a fixed size scanning spot and is characterized by high spatial resolution and a wide gray scale dynamic range. This is achieved with a high intensity spot of light derived from a solid-state laser that is scanned across the plate as the plate is moved perpendicular to the beam scan. As the laser scans the plate, the phosphor's stored x-ray attenuated equivalent energy is released as a different light wavelength. The emitted light is collected and digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav.

The LUMISCAN 135 houses a plate transport system, optics module and reading electronics. Separate from the LUMISCAN 135 is the eraser unit, Lumisys 135E, which incorporates high intensity lamps with a light-tight lid for returning the phosphors to zero.

The LUMISCAN 135 uses a solid state laser diode as the beam source. The laser is conditioned by a lens for beam forming and coupled to a fiber. From the fiber, the energy is directed to a scanning galvanometer. The galvanometer has a mirror that is oscillating precisely across the width of the plate and irradiating the plate with laser light. As the light impinges the plate, stored energy from the plate is emitted and collected in an integrating cylinder. The collected light is detected by a photomultiplier, converted to an analog signal which is logarithmically amplified, corrected for spatial variations in the integrating cylinder, and then digitized by an A/D converter.

The provided document does not contain explicit acceptance criteria and a detailed study proving the device meets these criteria in the typical sense of a clinical trial or performance evaluation with specific metrics. Instead, it is a 510(k) summary for a medical device (Lumiscan 135 Phosphor Plate Digitizer), which aims to demonstrate substantial equivalence to previously marketed devices.

The document primarily focuses on:

• Device Description and Intended Use: Explaining what the device does and how it functions.
• Hazard Analysis and Safety Concerns: Addressing potential malfunctions and compliance with safety standards.
• Substantial Equivalence Comparison: Benchmarking key technical specifications of the Lumiscan 135 against predicate devices (Fuji FCR AC-3, Kodak System 400 Reader, Agfa ADC Digitizer).

Therefore, I cannot populate all the requested fields with specific values directly from the provided text, as this type of information is generally not included in a 510(k) summary focused on substantial equivalence. However, I can extract the comparative technical specifications which serve as a form of "performance comparison" for substantial equivalence.

Here's an attempt to answer based on the available information, noting where data is absent or implied by the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are typically derived from demonstrating that the device is as safe and effective as a predicate device. This is often shown through comparable technical specifications. The table below uses the comparative technical specifications presented in the document as a proxy for "reported device performance" and implied "acceptance criteria" (i.e., being comparable to or better than predicate devices in these aspects).

Note on "Acceptance Criteria": In a 510(k) context, "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must perform comparably in its intended use, typically through technical specifications and safety profile, rather than meeting a specific clinical accuracy threshold like an AUC or sensitivity/specificity.

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

The document does not describe a specific "test set" or a formal study with patient data for performance evaluation in the way a clinical trial would. The 510(k) process for this type of device relies heavily on demonstrating substantial equivalence through technical specifications, engineering testing, and adherence to safety standards. Therefore, "sample size" and "data provenance" for a clinical test set are not applicable or mentioned.

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

This information is not provided in the document as no specific test set or ground truth establishment process is described for clinical validation. The submission is focused on technical equivalence.

4. Adjudication Method for the Test Set

Since no clinical test set is described, an adjudication method is not applicable and not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. The document focuses on the technical specifications of the digitizer itself, not its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This concept is not directly applicable to a phosphor plate digitizer. The device's primary function is to digitize analog X-ray information from a phosphor plate into a digital image for display and interpretation by a human. Its "performance" is inherent in the quality of the digitized image, measured by metrics like resolution, gray scale, dynamic range, and digitizing speed, as outlined in the comparison table above. There isn't an "algorithm-only" interpretation performance.

7. The Type of Ground Truth Used

As there's no clinical performance study involving diagnosis or interpretation described, the concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) in that sense is not applicable to this 510(k) summary. The ground truth for the technical specifications would be engineering measurements and calibrations.

8. The Sample Size for the Training Set

The document does not describe a "training set" for an algorithm, as this is a hardware device (digitizer) and not an AI/ML algorithm that requires training data in the modern sense.

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

Since no training set for an algorithm is described, this question is not applicable.

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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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