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The TightRail Guardian Motorized Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

The TightRail Guardian Motorized Dilator Sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:

1. Drive Assembly
2. Dilation Extension Selection (DES) Assembly
3. Motor Drive Handle
4. Outer Sheath Accessory
5. Fish Tape Accessory
   The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for guidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

The provided text describes the regulatory clearance for the TightRail Guardian Motorized Dilator Sheath and does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML powered device evaluation.

The document is a 510(k) summary for a medical device (a motorized dilator sheath), outlining its intended use, design, and comparison to predicate devices for regulatory clearance. It focuses on demonstrating substantial equivalence to existing devices, not on evaluating the performance of an AI/ML model.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (as it relates to AI/ML metrics).
• Sample size and data provenance for an AI/ML test set.
• Number of experts and qualifications for establishing ground truth in an AI/ML context.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study results for AI vs. without AI assistance.
• Standalone algorithm-only performance.
• Type of ground truth used for an AI/ML model.
• Sample size for the training set of an AI/ML model.
• How ground truth for the training set was established for an AI/ML model.

The document lists various Design Verification and Validation Testing performed, such as Simulated Use Testing, Human Factors Evaluation, and Biocompatibility testing. These are typical engineering and safety tests for a physical medical device, not performance metrics for an AI/ML algorithm.

The statement "Preclinical and clinical data was not required to demonstrate substantial equivalence" further indicates that this is a traditional medical device clearance, not one involving extensive clinical trials or AI/ML performance evaluation studies against specific acceptance criteria for diagnostic/prognostic accuracy.

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