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The Jumong Series Stationary Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This device represents a new combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the digital panel. The purchaser can select from one of four configurations. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Varian (RAD-14), and the collimator is the Ralco R225 ACS DHHS. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2. All major components are either UL or CSA listed.

The provided text is a 510(k) summary for the "Jumong Series Stationary Radiographic System." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and performance data from a standalone study. Therefore, much of the requested information cannot be extracted directly from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for image quality or clinical performance that the device was tested against. Instead, it relies on demonstrating that the device meets general safety and performance standards, and that its components (like digital panels) are previously cleared. The "performance" assessment is framed as "bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device" and that the device "conforms to US Performance Standards" and various IEC/NEMA voluntary standards.

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

The document mentions that "Clinical images were provided," but does not specify the sample size, data provenance (e.g., country of origin), or whether they were retrospective or prospective. It explicitly states these images "were not necessary to establish substantial equivalence."

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

This information is not provided in the document. The phrase "clinical images were provided" suggests some form of evaluation but no details on expert involvement or ground truth establishment for a test set.

4. Adjudication Method:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on technical characteristics and safety/performance standards, rather than a clinical trial comparing human reader performance.

6. Standalone Performance Study:

The document implies that images were used to show the "complete system works as intended," suggesting some form of standalone evaluation. However, it does not describe a formal standalone performance study with specific metrics, acceptance criteria, or a detailed methodology. The "non-clinical testing" section primarily covers integration, bench, safety, and software validation.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any clinical image evaluation, given that the clinical images were "not necessary to establish substantial equivalence."

8. Sample Size for the Training Set:

This information is not applicable as the document describes a device (X-ray system), not an AI algorithm that would typically require a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as the document describes a device (X-ray system), not an AI algorithm.

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Sedecal "NOVA FA DR System" is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

"NOVA FA DR System" refers to a full Digital Radiography system consisting of: NOVA: Automatic Ceiling Suspension NBS: Tilting Vertical Wall Stand system with CXDI Canon Detectors 401C / 401C Compact / 55C / 501C (Option 1) NET: Elevating Table with CXDI Canon Detector (same detectors as Wall Stand) (Option 2) Flexi DT: Mobile Elevating Table SEDECAL SHF Generator Series, output powers: 50 kW / 65 kW / 80 kW Toshiba Tube: maximum heat dissipation: 300 kHU / 400 kHU Ralco Collimator: Manual / Motorized

Here's a breakdown of the acceptance criteria and study information for the Sedecal "NOVA FA DR System" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a modification to an existing X-ray system (K090279). The acceptance criterion for this modification is implicitly to demonstrate that the modified device is as safe and effective as the predicate device, with images of at least comparable quality.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "various human body structures (chest, skull, abdomen, extremities)" were acquired, but no number of cases or patients is provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study used "clinical images," implying prospective acquisition for the purpose of the study, but this is not explicitly confirmed. Given Sedecal is based in Spain, it's plausible the images were acquired there, but this is speculation.

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

• Number of Experts: One.
• Qualifications of Experts: "Board Certified Radiologist." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: None explicitly mentioned. With only one radiologist, there was no need for adjudication for consensus.

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 or AI comparative effectiveness study was performed or mentioned. This submission is for a modification to a digital X-ray system, not an AI-powered diagnostic tool. The focus is on the imaging system itself, not on reader performance improvement with or without AI.

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

• This is not applicable as the device is a digital X-ray system, not an algorithm, and its performance inherently involves human operation and interpretation.

7. The Type of Ground Truth Used:

• Ground Truth Type: Expert opinion/evaluation by a Board Certified Radiologist. The "good quality, high resolution, and clinically acceptable" assessment served as the ground truth for image quality.

8. The Sample Size for the Training Set:

• Not applicable/Not mentioned. This document describes a 510(k) for a hardware modification and new detectors, not an AI/machine learning algorithm that requires a training set. The "testing" refers to verification and validation of the hardware performance, software integration, and image quality.

9. How the Ground Truth for the Training Set Was Established:

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

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