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The CROSSER CTO Recanalization System indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy.

The CROSSER Catheter is only intended for use with the CROSSER Generator. Refer to the CROSSER Generator Manual of Operations for proper use.

The CrossER® Catheter is a high frequency mechanical recanalization system designed for recanalization of obstructed peripheral arteries. The system consists of an electronic CROSSER® Generator, Foot Switch, high frequency Transducer, and CROSSER® Catheter. The CrossER® CTO Recanalization catheter, which is intended for one procedure only, is connected to the CROSSER® Generator through the high frequency Transducer. The Foot Switch is used to activate the CROSSER® Recanalization System. The CROSSER® Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated to the tip of the CROSSER® Catheter.

The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) summary for a medical device (CROSSER CTO Recanalization Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It describes the device, its indications for use, and a summary of nonclinical performance testing related to a new marking system.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance in the context of clinical outcomes or diagnostic accuracy.
2. Details on sample sizes for test sets, data provenance, or information about retrospective/prospective studies.
3. Information about experts, ground truth establishment, or adjudication methods.
4. Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with/without AI assistance.
5. Details on standalone algorithm performance.
6. The type of ground truth used (e.g., pathology, outcomes data).
7. Sample sizes for training sets.
8. How ground truth for training sets was established.

The performance testing mentioned (GEOALIGN® Marking Legibility, Dimensional Analysis, Durability, Compatibility) are all non-clinical tests focusing on the physical characteristics and performance of the device's new marking system, not on its clinical effectiveness or diagnostic accuracy which would typically involve the kind of data you are asking for.

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