(20 days)
The TightRail and TightRail Mini Rotating Dilator Sheaths are intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects
The TightRail and TightRail Mini Rotating Dilator Sheaths are intra-operative devices. The devices consist of a proximal handle drive mechanism with a distal dilation sheath. Each rotating dilator sheath is packaged with an optional outer support sheath. The dilator sheath is advanced, withdrawn, and rotated about the lead, catheter, or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the dilation sheath. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal thereby facilitating removal of said object. For the TightRail the diameter sizes range from 9 French (F) to 13 F with a nominal effective length of 47.5cm. For the TightRail Mini, the diameter sizes range from 9 French (F) to 11 F with a nominal effective length of 15.5 cm.
I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets the acceptance criteria as requested. The document is a 510(k) summary for the Spectranetics TightRail and TightRail Mini Rotating Dilator Sheaths, which details their technological characteristics and testing performed for substantial equivalence to a predicate device.
Specifically:
- No acceptance criteria: The document lists various tests performed (e.g., Dimensional Verification, Tri Coil Tensile Test, etc.), but it does not provide specific acceptance criteria or thresholds for these tests.
- No device performance metrics: While it states "the subject device met all requirements as identified in the risk analysis," it does not report specific device performance metrics in a quantitative manner or in relation to defined acceptance criteria.
- No information on "AI" or "human readers": This device is a medical instrument (dilator sheath), not an AI-powered diagnostic or assistive tool. Therefore, there is no mention of AI, human readers, MRMC studies, effect sizes of AI assistance, or standalone algorithm performance.
- No ground truth, training/test sets, or expert details: For a medical device like this, which is an interventional tool, the concept of "ground truth" as typically applied to diagnostic AI models (e.g., pathology, expert consensus on images) is not directly relevant in the context of this 510(k) summary. The summary focuses on device functionality, materials, and mechanical performance rather than diagnostic accuracy. Consequently, there is no information about training sets, test sets, data provenance, number of experts, or adjudication methods for establishing ground truth.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K142546) based on similar design and performance without requiring preclinical or clinical data for this specific submission because the changes were considered minor (material of the trigger pin). The testing performed was generally for design verification and validation, ensuring the device functions as intended and safely, rather than evaluating diagnostic accuracy against a ground truth.
Therefore, I cannot fulfill the request to provide the table or the detailed information regarding acceptance criteria and study particulars in the context of an AI-driven device.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).