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PodSKAN HF Diagnostic X-Ray System is intended for use by the qualified and trained clinicians or radiographers for generating X-rays of feet. It can be used for adults and paediatrics.

PodSKAN is not intended for Mammography and Fluoroscopy Applications.

PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A wall socket with 120 VAC or 240 VAC, 50/60 Hz. The technology incorporates feedback circuits to ensure highest accuracy & reproduceability of X-Ray output. It consists of

• . Tube head assembly (including collimator and goniometer)
• Base foot platform and side handle for patient support .
• External console and Hand switch .

PodSKAN HF diagnostic X-ray system can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software. Skanray recommends using 510(k) cleared flat panel detectors with AED functionality wired or wireless of size 10"x12" or 14"x17"and image acquisition systems to maintain compliance and quality

The provided document is a 510(k) summary for the PodSKAN HF Diagnostic X-ray System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, the acceptance criteria and study details as requested (sample size, data provenance, ground truth establishment, MRMC study, standalone performance) are not explicitly present in the provided text. The document refers to compliance with various IEC standards and FDA performance standards (21 CFR 1020.30-1020.31) but does not present a specific study with defined acceptance criteria and reported device performance in a tabular format as requested for a diagnostic AI/medical device.

However, I can extract the relevant information regarding performance and compliance from the document and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with "acceptance criteria" and "reported device performance" in the context of a diagnostic accuracy study. Instead, it discusses compliance with regulatory standards and compares technical specifications to predicate devices.

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 states: "The validation testing, which includes sample clinical images, demonstrates compliance to the diagnostic quality imaging performance when used with 510k cleared detector and imaging software for the intended application."
• No specific sample size for a test set (e.g., number of images/patients) is provided.
• No data provenance (country of origin, retrospective/prospective) is mentioned.
• This device is an X-ray system (hardware), not an AI diagnostic algorithm. The "validation testing" with "sample clinical images" appears to be for general image quality assessment of the hardware, not for diagnostic accuracy of an AI.

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

• Not applicable/Not mentioned. Since this is a submission for an X-ray hardware system, not an AI diagnostic algorithm, the concept of "ground truth" for diagnostic labels established by experts is not discussed in the provided text. The performance data focuses on compliance with physical and electrical standards for X-ray generation and image quality.

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

• Not applicable/Not mentioned. This information is typically relevant for studies evaluating the diagnostic accuracy of a software algorithm, particularly when establishing a consensus ground truth. It is not discussed for this X-ray hardware system.

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 MRMC comparative effectiveness study was performed or mentioned. The device is an X-ray system, not an AI software intended to assist human readers.

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

• Not applicable. This refers to the standalone performance of an AI algorithm. The PodSKAN HF Diagnostic X-ray System is hardware.

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

• Not explicitly defined/Not applicable in the typical sense for a diagnostic algorithm. For an X-ray hardware system, "ground truth" would relate to the physical and radiation output accuracy relative to established standards (e.g., kV accuracy, mAs reproducibility, HVL), as well as the ability to produce images of "diagnostic quality," which is assessed qualitatively or against established phantom images/standards rather than disease-specific pathology or outcomes data in this context.

8. The sample size for the training set

• Not applicable. The device is hardware, not a machine learning model that undergoes a training phase.

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

• Not applicable. As above, this is hardware, not an AI/ML system requiring a training set with established ground truth.

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