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The Valvulotome by Koven Valvulotome is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.

The Valvulotome by Koven is a medical device that has a deployable assembly with multiple deployable cutting blades and guide fins which permit continual centralizing, and alignment of the cutting blades within the lumen of the vein as the valves are being cut. The device includes a handle operatively associated with this deployable assembly through a catheter operated by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position. The Valvulotome by Koven consists of three main parts; the handle, the catheter and the cutter head.

The provided text describes a medical device, the "Valvulotome by Koven," and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria, device performance metrics, or details of a study that would typically quantify its performance against such criteria.

The 510(k) summary primarily focuses on:

• Device Description: What the device is, its parts, and materials.
• Intended Use: For excising or disrupting venous valves during in-situ vascular procedures.
• Substantial Equivalence: Comparison to a predicate device (Lemaitre Valvulotome II, K946352).
• Testing: It states that testing was done, including "laboratory bond strength testing of all joined elements" and "bench testing for the determination of adequacy and safety of the device for the disruption of valves in blood vessels of the leg." It concludes that the device "successfully completed all testing with positive end points achieved."

Missing Information:

The document explicitly lacks the following information required to answer your prompt adequately:

• Specific Acceptance Criteria: No quantitative thresholds or qualitative standards are defined for "successful completion."
• Reported Device Performance: No specific data (e.g., success rates, force measurements, blade sharpness metrics, time to complete a procedure, etc.) from the testing is provided.
• Study Design Details:
  • No sample size for test sets (e.g., number of valves tested, number of devices tested).
  • No data provenance (country, retrospective/prospective).
  • No mention of experts, ground truth establishment, or adjudication for any performance testing.
  • No MRMC study details or AI components.
  • No standalone algorithm performance (as it's a mechanical device).
  • No details on training set size or ground truth for a training set.

Therefore, based solely on the provided text, I cannot complete the requested tables and details.

The document's statement: "The Valvulotome by Koven successfully completed all testing with positive end points achieved" is a summary of the outcome, but it does not provide the underlying data or the specific criteria for "successful completion" that would be needed to fill the table. It indicates that some form of "adequacy and safety" was determined through bench testing related to disrupting valves, but the metrics are not specified.

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