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The Symphony 200 is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology).

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The provided document is a 510(k) clearance letter from the FDA for a device called "Symphony 9090 Remote Control Table." This document primarily addresses the FDA's determination of substantial equivalence and does not contain detailed information about acceptance criteria, device performance studies, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a study report or technical specification detailing performance metrics.

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The Pathfinder Mobile C-Arm is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, hip pnnings, and pacemaker implants).

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This 510(k) summary does not contain the detailed information necessary to complete the requested table and answer all the questions. The provided document is a notification of substantial equivalence for a medical device (Pathfinder Mobile C-Arm) and focuses on regulatory approval rather than a detailed study report.

Here's what can be inferred and what is missing based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The 510(k) clearance letter confirms that the device is "substantially equivalent" to predicate devices, but it does not detail specific performance characteristics or acceptance criteria used in a clinical or technical study.

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

• Sample size for test set: Not available in the document.
• Data provenance (country of origin, retrospective/prospective): Not available in the document. It's common for 510(k) submissions to reference studies, but the details of those studies are not typically included in the clearance letter itself.

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

Not available in the document. The clearance letter does not describe any human expert review process for a test set.

4. Adjudication method for the test set:

Not applicable/Not available. Since details of a test set and ground truth establishment are not provided, an adjudication method cannot be determined.

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. This device is a Mobile C-Arm, which is an imaging hardware device, not an AI or software-based diagnostic algorithm that would typically involve human readers interpreting images with or without AI assistance. Therefore, an MRMC comparative effectiveness study in the context of AI assistance is highly unlikely for this type of device.

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

Not applicable. This device is a hardware imaging system, not a standalone algorithm.

7. The type of ground truth used:

Not available/Not applicable. As the document does not describe a study involving a "ground truth" for diagnostic accuracy, this information cannot be extracted. The substantial equivalence determination for this type of device typically relies on demonstrating that the new device performs as intended and is as safe and effective as a legally marketed predicate device, often through engineering, bench, and sometimes limited clinical testing for safety and basic image quality, rather than a diagnostic accuracy study with a rigorous ground truth.

8. The sample size for the training set:

Not applicable. As this is a hardware device and not an AI algorithm, there would be no "training set" in the context of machine learning.

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

Not applicable. See point 8.

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Ask a specific question about this device