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The PCR Eleva 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 PCR Eleva 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 Eleva consists of one or more workspots with PCR Eleva Software and one or more image plate readers. All components are connected via standard ethernet. The system complies with the ACR/NEMA DICOM Version 3 Digital Image Communication in Medicine Standard. 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 Eleva 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 Eleva workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The Eleva Workspot is also used for the scheduling of patients and exams. The Eleva Workstation consists of a PC, a keyboard, a monitor, and an optional bar-code reader.

The provided document is a 510(k) submission for the Philips PCR Eleva 1.2, a digital film processing system. It outlines the device's identification, predicate device, indications for use, and a summary of nonclinical tests. However, it does not contain the detailed information required to answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly within the context of AI performance or clinical efficacy studies.

This submission is a Special 510(k), which focuses on modifications to an existing device (Philips PCR 5.2). The core claim is that these modifications do not change the indications for use or alter the fundamental scientific technology, and therefore, the new device is at least as safe and effective as the predicate. The "study" referenced is primarily a verification and validation process against requirement specifications and risk management results, rather than a clinical trial demonstrating performance against specific clinical metrics.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document states: "All acceptance criteria for a product release according to our product release policy are met." However, it does not explicitly list the specific acceptance criteria or provide a table of reported device performance against those criteria. It generally refers to "requirement specifications and risk management results" and "software verification, validation and DICOM conformance testing" as areas where tests were performed.

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

This information is not provided in the document. The submission mentions "verification and validation tests were performed on the complete system," but it does not detail the nature of a specific test set (e.g., patient images), its sample size, or its provenance.

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 provided. As the submission primarily concerns system modifications and verification, and not a clinical performance study with human readers assessing images, the concept of "ground truth established by experts" for a test set in the clinical sense is not discussed.

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

This information is not provided.

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

There is no mention of an MRMC comparative effectiveness study, nor any discussion of AI assistance or its effect size on human readers. This submission predates widespread integration and evaluation of AI in medical imaging devices in this manner (2009). The device is described as a "digital film processing system," which digitizes X-ray images for viewing, storage, post-processing, and printing. It is not presented as an AI-powered diagnostic aid.

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

This information is not applicable/provided in the context of an AI algorithm. The device itself is a system for processing and managing images, not a standalone diagnostic algorithm.

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

The document does not detail how "ground truth" (in a clinical sense related to disease presence/absence) was established for any specific image test set. The "ground truth" in this context refers to the device's functional performance against its technical specifications and regulatory requirements, not clinical diagnostic accuracy.

8. The sample size for the training set

This information is not provided and is not applicable in the context of this device development, as it is not an AI-driven system that would typically undergo a "training" phase with a dataset of labeled clinical images.

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

This information is not provided and is not applicable for the reasons stated above.

In summary:

The Philips PCR Eleva 1.2 Special 510(k) submission describes updates to a Computed Radiography system. The "study" referred to is a series of nonclinical verification and validation tests (software, DICOM conformance, and assessment against requirement specifications and risk management results) ensuring the modified device remains as safe and effective as its predicate. It does not present clinical performance data, AI performance metrics, or details about expert-adjudicated test sets. The nature of this 510(k) (Special 510(k) for device modifications) means a full-scale clinical trial with specific performance metrics against a defined acceptance criterion and a large, expert-adjudicated test set was likely not deemed necessary by the manufacturer or required by the FDA at the time for this type of device modification.

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