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As a part of a radiographic system, the Pixium 4343RCE is intended to acquire digital radiographic images. The Pixium 4343RCE is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

The pixium 4343RCE is a Stationary x-ray system that converts x-ray patterns into electrical signals. The signals are converted into visible images for use in medical diagnosis. In the device, a cesium iodide scintillator absorbs the input x-ray photons. The scintillator in turn emits visible spectrum photons that illuminate an array of photodetectors that create an electrical charge representation of the x-ray input. A matrix scan of the array converts the integrated charges into a modulated electrical signal.

The detector is permanently installed and intended to be integrated into an x-ray system, where it constitutes an x-ray receptor for direct x-ray imaging. It is electrically powered by and connected with the x-ray system. The device is connected to the Philips Eleva Workspot to create a complete x-ray imaging chain, and it is intended to be used in Philips x-ray systems such as the DigitalDiagnost.

The provided text describes the Philips pixium 4343RCE, a stationary x-ray system. The document is a 510(k) summary for premarket notification to the FDA, asserting substantial equivalence to a predicate device (Philips pixium 4343RC, K131483).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present specific numerical acceptance criteria (e.g., minimum DQE, MTF values that must be met) for the pixium 4343RCE, nor does it provide a direct side-by-side comparison of claimed performance data against such defined criteria. Instead, the acceptance criteria are implicitly stated as demonstrating similar performance to the predicate device and compliance with various standards. The "Discussion" column in the comparison table serves as the "reported device performance" against the implicitly accepted criterion of not negatively impacting safety or effectiveness compared to the predicate.

Here's a table summarizing relevant performance metrics and the discussion provided, which indicates how the device meets (or is considered to meet) implied acceptance criteria of non-inferiority or slight improvement:

The study that proves the device meets the acceptance criteria is detailed as "Non-clinical verification and validation tests." These tests cover the intended use, technical claims, requirement specifications, and risk management results. The document explicitly states: "Non-clinical verification and validation test results demonstrate that the pixium 4343RCE... Meets the acceptance criteria and is adequate for its intended use." The basis for this is "compliance with the aforementioned international and FDA-recognized consensus standards and device specific guidance document" and showing "identical or equivalent technological characteristics," "equivalent diagnostic capability," and no "new potential hazards or safety risks" compared to the predicate.

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

The document does not specify a separate "test set" in the context of data used for a clinical performance evaluation, as it explicitly states that no clinical study was required. The non-clinical verification and validation tests are performed on the device itself (hardware and software) and against established technical specifications and standards (e.g., ISO, IEC, NEMA, FDA guidance). Therefore, there is no mention of a "sample size" of patient data or "data provenance" (country of origin, retrospective/prospective) for a clinical test set.

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

Since no clinical study was conducted, there was no "test set" of patient data requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable as no clinical test set requiring adjudication was used.

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

Not applicable. The device is a digital x-ray detector, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or mentioned.

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

This refers to the performance of the device itself (the x-ray detector) as a standalone component without human interpretation being part of the primary evaluation. The "Summary of Non-clinical Performance Data" and the "Comparison" tables effectively serve as the standalone performance assessment. The device's performance metrics (MTF, DQE, SENR, image readout speed, etc.) are evaluated directly for the detector. The conclusion is that "the device is as safe, as effective, and performs as well or better than the predicate device" in terms of its technological characteristics and ability to produce images.

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

For the non-clinical performance evaluation, the "ground truth" is based on technical specifications, international and FDA-recognized consensus standards, and device-specific guidance documents. For instance, the MTF and DQE values are compared against those of the predicate device, with the implicit ground truth being that comparable or improved values demonstrate equivalent performance.

8. The sample size for the training set

Not applicable. The document describes an x-ray detector, not an AI algorithm that requires a training set of data.

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

Not applicable as there is no training set mentioned for this device.

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