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ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during othopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except paediatric patients within the limit of the device.

ARCO FP-S is a mobile C-arm with the solid-state image detector "Flat Panel". It will be realized in 2 models, depending on the size of the detector: Model: ARCO FP-SR21 Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 21x21 cm, 1024x1024 pixel. Models: ARCO FP-SR30 Dual focus 0.3/0.6 mm, rotating anode X-Ray tube, generator nominal power 5 KW. Detector size 30x30 cm, 1536 x 1536 pixel. The system consists of: C-arm Stand, X-RAY MONOBLOC, rotating anode, FLAT PANEL DETECTORS: 2121cm or 3030cm, MONITOR LCD 27" QUAD HD format 16:9, CONTROL PANEL, X-RAY COLLIMATOR, SYSTEM CONTROLLER, X-RAY HAND SWITCH, ARTICULATED ARM FOR MONITOR SUPPORT, ANTISCATTERING GRID. Optional components include FOOTSWITCH, two-foot pedal, LASER LOCALISER, Dose Area Meter, DSA Packages, I.R. remote controls, DICOM Classes, EXTERNAL VIDEO OUTPUT-Wireless transmission, DICOM DATA Wi-Fi transmission to Ethernet/PACS, NFC LOGIN, Wireless monitor trolley, model TROTTER W, for duplicating the image of the monitor on board.

The provided text describes a 510(k) premarket notification for a medical device called ARCO FP-S, a mobile X-ray device. The submission aims to demonstrate substantial equivalence to a predicate device (ARCO FP K182086). The study is primarily a non-clinical bench test and radiologist's image evaluation to confirm that the changes made to the device (specifically, the digital x-ray receptor panels) do not negatively impact its performance or safety compared to the predicate.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table format with pass/fail thresholds in the provided document. Instead, the document asserts "substantial equivalence" based on various performance specifications relative to the predicate device and the evaluation of image quality by a radiologist. The implicit acceptance criterion is that the performance of the ARCO FP-S, especially concerning image quality, must be at least equivalent to, or better than, the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated in terms of a numerical count of images or cases. The document mentions a "Radiologist's Images evaluation" where the radiologist reviewed "the still and moving images acquired by the newer digital receptor panels." It does not specify how many images or what types of images were reviewed.
• Data Provenance: The images were "acquired by the newer digital receptor panels" (PaxScan), implying they are current acquisitions using the modified device. The document does not specify the country of origin or whether the data was retrospective or prospective. Given it's a bench test, the images were likely acquired in a controlled setting for testing purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: One ("A Board Certified Radiologist").
• Qualifications of Experts: "Board Certified Radiologist." No specific information about years of experience is provided.

4. Adjudication method for the test set

• Adjudication Method: Not applicable or "None" in the typical sense of multiple readers and consensus. A single Board Certified Radiologist evaluated the images.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly stated or described. The evaluation involved a single radiologist reviewing images to confirm diagnostic quality, not a comparison of human readers with and without AI assistance. The device itself is a C-arm X-ray system, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable for this device as it is an X-ray imaging system, not an AI algorithm performing diagnostic interpretations. The "performance" being evaluated is the quality of the raw images produced by the system.

7. The type of ground truth used

• Type of Ground Truth: "Expert consensus" in a limited sense, as it was the subjective assessment of a single Board Certified Radiologist who determined the images were of "good and acceptable diagnostic quality." This is essentially expert opinion on image interpretability for diagnostic purposes. It is not pathology, outcomes data, or an objective gold standard.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The ARCO FP-S is a hardware device (X-ray system) with upgraded software. There is no mention of a machine learning component requiring a "training set" of images for an AI algorithm. The software upgrade is described as "FUNCTIONALLY IDENTICAL" to the predicate's software.

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

• Ground Truth for Training Set: Not applicable, as there is no specified training set for a machine learning algorithm.

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