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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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SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.

SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.

SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.

The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults.

SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.

SKANMOBILE consists of following sub-assemblies:

1. Tube head
2. SKANMOBILE trolley

SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows:

1. Touchscreen operator console.
2. Modified brake mechanism for wheels
3. Modified cassette tray to house the cassette / flat panel detectors.

Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices.

The provided text does not contain information about specific acceptance criteria or an internal study demonstrating that the device meets those criteria. Instead, it focuses on the device's substantial equivalence to predicate devices, compliance with regulatory standards, and summarizes non-clinical performance data.

Therefore, I cannot populate the table of acceptance criteria or provide details about a study proving the device meets acceptance criteria as described in your request. The document explicitly states that "clinical studies are not required" for this submission, further indicating the absence of a study focused on proving specific performance metrics against pre-defined acceptance criteria in a clinical setting.

However, I can extract information related to the device's performance, testing, and ground truth establishment in a general sense based on the provided text, especially concerning the evaluation of the flat panel detectors which are a key component.

Here's an analysis of what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

As mentioned, explicit acceptance criteria are not presented in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to various electrical, safety, and image quality standards (DQE, MTF).

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

• Test Set Sample Size: Not specified in terms of number of images/patients.
• Data Provenance: Not specified. It mentions testing was done "both in-house and by outsourcing to appropriate third-party vendors." The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

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

• The document states that "The quality of the images obtained from the subject devices were analysed by a radiographer and a radiologist and it was found the images were of good quality which were easily read by the radiologist".
• Number of experts: At least one radiographer and at least one radiologist ("a radiographer and a radiologist").
• Qualifications: "radiographer" and "radiologist." No specific years of experience are mentioned.

4. Adjudication method for the test set:

• Not specified. The text simply says "analysed by a radiographer and a radiologist." It does not describe a formal adjudication process (e.g., 2+1, 3+1).

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 done. The device described is a mobile X-ray system, not an AI-assisted diagnostic tool for image interpretation.

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

• Not applicable as this is an X-ray imaging system, not an algorithm for image interpretation. The "software/firmware" described primarily controls the operation of the device and integrates with image acquisition software.

7. The type of ground truth used:

• For image quality, the ground truth was "expert consensus" implicitly, as it was determined by the analysis of a radiographer and a radiologist who found the images to be of "good quality" and "easily read."
• For technical specifications (DQE, MTF, electrical safety, etc.), the "ground truth" or reference was compliance with various international standards (IEC, ISO, NEMA, ASTM, 21 CFR).

8. The sample size for the training set:

• Not applicable. The document discusses a physical X-ray device and its control software. There is no mention of a "training set" for an AI or machine learning algorithm. The software development "has been executed as per the requirements of ISO 62304" and undergone "software validation & verification," not machine learning training.

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

• Not applicable, as there is no training set for an AI/ML algorithm mentioned.

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