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The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a catheter accessory device intended for the minimally invasive removal of tunneled long term catheters. The Cuffed Catheter Removal Device is indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French

Symmetry Surgical Single Use Cuffed Catheter Removal devices are sold as sterile, single use devices, unless otherwise noted. The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a tool for minimizing surgical trauma associated with catheter removal. The device jaws are normally in the closed position. The device is equipped with a trigger, a button located on the handle, actuated feature that opens the jaws. Upon release of the trigger, the jaws return to the normally closed position with a spring assist mechanism. The Single Use Cuffed Catheter Removal Device has no locking mechanism. During use the jaws are opened outside the patient and allowed to close around the catheter. The catheter then serves as a guide for moving the closed tip down into the catheter tunnel. When cutting the catheter cuff, the jaws may be activated to allow for tissue dissection and release which will then ease the catheter removal. The opening of the jaws in vivo are limited by the constraint of the surrounding tissue tunnel as well as the design limit of no more than a maximum angle of 57°.

The provided text describes a 510(k) submission for the Symmetry Surgical Single Use Cuffed Catheter Removal Device. This submission primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and performance testing. Crucially, clinical data was not required for this device, and therefore, the information typically associated with studies proving device performance against acceptance criteria for AI/ML devices is not present.

The document outlines an animal study and biocompatibility testing as the basis for substantial equivalence, but it does not detail specific acceptance criteria or performance metrics in a way that aligns with the request for AI/ML device evaluations.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it pertains to a physical medical device that did not require clinical trials for its 510(k) clearance due to its classification and the nature of its equivalence claim.

However, I can extract the available information that relates to performance assessment, even if it doesn't fit the typical "acceptance criteria" and "device performance" format for AI/ML.

1. Table of Acceptance Criteria and Reported Device Performance

As clinical data was not required and this is not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) is not applicable. Instead, the performance assessment focused on demonstrating safety and functional equivalence through non-clinical testing.

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

• Sample Size: Not specified for any specific performance test in the document. The document mentions "animal study and biocompatibility testing," but doesn't provide the number of animals or samples used.
• Data Provenance: The studies were non-clinical (animal study and biocompatibility testing). No country of origin for data is stated, but the submission is to the US FDA. The studies were likely prospective experimental tests, not retrospective analyses.

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

Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on image interpretation, pathology reports) was not established for this device. Performance was assessed through engineering and biocompatibility testing, not human expert evaluations of diagnostic output.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described as clinical data or human interpretive tasks were not required.

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 is a physical surgical instrument, not an AI/ML diagnostic aid. No MRMC study was conducted.

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

Not applicable. This is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be based on physical and biological standards and measurements as opposed to clinical outcomes or expert labels. This includes:

• Physical measurements against design specifications (e.g., jaw opening angle, compatibility with catheter sizes).
• Biocompatibility test results against established safety thresholds (e.g., cytotoxicity, sensitization, irritation as per ISO 10993).
• Animal physiological responses during the animal study, likely assessing tissue response, ease of removal, or absence of adverse events, compared to a control or predicate device (though specific outcomes are not detailed).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.

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

Not applicable. There is no training set.

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