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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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The PCR 5.2 System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The Philips PCR system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.

A PCR system consists of an image reader, one or more PCR User Terminals, and an Easy Vision PCR Printstation or optional EasyVision RAD workstation.

Imaging plates are exposed via conventional X-Ray devices. The imaging plates used in PCR systems are coated with a luminescent material which acts as an x-ray detector. It stores the x-ray image in the form of excited charge carriers. An exposed imaging plate is loaded into the image reader of the PCR system and the image stored on the imaging plate is scanned with a laser and converted to digital data. The digital X-ray image data is then routed to the EasyVision PCR Printstation or optional EasyVision RAD workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The PCR User Terminal is used for the scheduling of patients and exams.

The PCR User Terminal consists of a Pentium-based PC, a keyboard, an operator terminal with function keys, and an optional bar-code reader. PCR User Terminals may be interconnected via standard ethernet.

Three image reader types, currently AC2, AC3 and 9000, can be connected to the system in order to meet different requirements based on image plate size and throughput.

The EasyVision PCR Printstation is a workstation that provides image storage, display, printing and processing functions using a SUN computer. The optional EasyVision RAD workstation is also a SUN computer that provides the same functions as the Printstation but it also provides more storage capability and additional post-processing functions. Both workstations are able to export digital images to the network via the DICOM protocol.

Digital image data from the image readers are processed based on selection of either an UnSharp Masking (UM) algorithm or a Dynamic Range Reconstruction (DRR) algorithm.

This 510(k) summary for the Philips Computed Radiography (PCR) 5.2 system describes a device that digitizes X-ray images. The primary focus of the document is on establishing substantial equivalence to a predicate device and outlining its functions. Consequently, the document does not contain details about specific acceptance criteria, a dedicated study proving device performance against those criteria, or many of the specific study design elements you requested.

Here's an attempt to answer your questions based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in comparison to such criteria. Instead, it focuses on demonstrating compliance with general electrical safety and communication standards, and substantial equivalence to a predicate device.

The "Performance Standards" section notes:
"This device complies with the relevant national and international standards for electrical safety (UL-1950. IEC-601-1, and IEC-950) as well as the international standard for electromagnetic compatibility (IEC-601-1-2) and the ACR/NEMA DICOM Version 3.0 digital imaging communication standard."

The "Substantial Equivalence Information" section implies performance is acceptable if it's "substantially equivalent" to previously cleared devices. Specifically, it notes that the new DRR algorithm is "substantially equivalent" to the Unsharp Mask (UM) algorithm and the Dynamic Range Control (DRC) algorithm. It states: "Processing with DRR improves low contrast resolution."

Therefore, we can infer the implied acceptance criteria are:

• Compliance with cited electrical safety and EMC standards.
• Compliance with DICOM 3.0 standards.
• Substantial equivalence in performance to the predicate device (Philips PCR ACe system) and its associated algorithms (UM and DRC for image processing), with an improvement in low contrast resolution with the new DRR algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide any information regarding a test set, its sample size, or data provenance. The assessment appears to be based on engineering comparisons and references to existing cleared devices rather than a new clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text. There is no mention of ground truth establishment by experts for a test set.

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

This information is not available in the provided text.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an "Automatic Radiographic Film Processor" (Computed Radiography system), which digitizes X-ray images. While it performs "Image Processing" with algorithms like DRR, it is not described as an "AI" system in the contemporary sense, nor is there any mention of a study evaluating improvements in human reader performance with or without its assistance.

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

The document does not detail a standalone performance study. It describes the system's functions (image reading, processing, viewing, printing, storage, export) and emphasizes its equivalence to predicate devices. The claim "Processing with DRR improves low contrast resolution" is a statement about the algorithm's effect, but not presented as the result of a formal standalone performance study with metrics.

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

The document does not describe the establishment or use of ground truth for evaluating the device's image processing capabilities. The primary evaluation method seems to be through comparison and demonstration of "substantial equivalence" of its technological characteristics (including algorithms) to previously cleared devices.

8. The sample size for the training set

The document does not mention any training set size. As the device involves image processing algorithms like UnSharp Masking and Dynamic Range Reconstruction, these algorithms would have been developed and tuned, but the text does not refer to a "training set" in a machine learning context.

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

Not applicable, as no training set is mentioned in the context of device evaluation.

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