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The BD Recanalization System (console and footswitch) and Crosser iQ™ Ultrasonic CTO Device are indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.

Crosser iQ™ Ultrasonic CTO Device: The Crosser iQ™ Ultrasonic CTO Device is intended for use only with the BD Recanalization System (console and footswitch).

BD Recanalization System: The BD Recanalization System (console and footswitch) is intended for use only with the Crosser iQTM Ultrasonic CTO Crossing Device.

The BD Recanalization System (Console and Footswitch) includes a non-sterile, reusable console with an integrated roller pump and user interface, as well as a footswitch. The footswitch can be used as an alternative to the hand-controlled activation of the Crosser iQ™ Ultrasonic CTO Device. The console delivers ultrasonic energy to the Crosser iQ™ Ultrasonic CTO Device. The console is comprised of a molded outer housing and internal structural components to support and protect the electro-mechanical components, including the internal generator. The user interface includes an LCD screen to display images for guiding system preparation and use. The back of the console includes an AC power control switch and clamp assembly to allow the user to secure the console to an IV pole before the procedure and remove after, if desired. The roller pump delivers sterile saline for irrigation from a saline bag through the Crosser iQ™ Ultrasonic CTO Device saline tubing to the tip of the crossing catheter. The saline bag is not included with the BD Recanalization System. In addition to initial package labeling is present on both the front and back of the console to aid the user in identifying console interface features.

The Crosser iQ™ Ultrasonic CTO Device is a single use crossing catheter, consisting of a catheter assembly, handle, power cord, and saline tubing with spike set. The Crosser iQ™ Ultrasonic CTO Device is connected to the console via the power cord, through which AC power is converted into high frequency ultrasonic mechanical vibrations to the tip by a transducer within the Crosser iQ™ CTO Device handle. The Crosser iQ™ Ultrasonic CTO Device includes the GeoAlign™ Marking System along the working length of the catheter assembly, with a hydrophilic coating over the distal portion of the working length. 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 1 cm increment bands with an accuracy within ± 1 mm. The distance from the distal catheter tip is labeled in 10 cm increments. Thicker bands denote the midway point (5 cm) 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 reqarding 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. The GeoAlign™ Marking System provides an approximation that may not be an exact representation of the actual distance traveled intravascularly and should be confirmed under fluoroscopy. The GeoAlign™ Marking System includes non-radiopaque white markings and are designed to be utilized outside the sheath.

The provided text describes the Crosser iQ™ CTO Recanalization System and its performance data to demonstrate substantial equivalence to a predicate device. It includes information on a summative usability study and an animal study.

Here's the extracted information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of discrete acceptance criteria with numerical performance metrics for the summative usability study or the animal study. Instead, it states high-level conclusions:

2. Sample sized used for the test set and the data provenance

• Summative Usability Study:

  • Sample Size: 15 physicians and 15 technologists (total 30 participants).
  • Data Provenance: Not explicitly stated, but implies a simulated environment given the description of "simulated CTO procedure."

• Animal Study:

  • Sample Size: 9 animals (non-diseased porcine, with each animal receiving six individual/non-overlapping treatments).
  • Data Provenance: Not explicitly stated, but implies laboratory setting for a GLP animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Summative Usability Study: The "participants" (15 physicians and 15 technologists) were the users being evaluated, not establishing ground truth. The study assessed their use of the device. Qualifications are implicitly "physicians" and "technologists."
• Animal Study: The document mentions "necropsy for gross examination" and "histological analysis" by unspecified personnel, but does not detail "experts" establishing ground truth in the way one might for diagnostic AI. The "ground truth" here is the biological/physiological response observed and assessed by the study's protocol and investigators.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not explicitly mentioned for either study.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human readers improving with AI assistance. This device is a physical medical device (catheter system), not an AI-powered diagnostic tool.

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

This question is not applicable. The device is a physical medical device, not an algorithm. Its performance is inherent in its physical and mechanical operation, guided by human operators.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Summative Usability Study: The "ground truth" was likely defined by the success or failure of participants to complete tasks as outlined in the Instructions for Use (IFU) and the evaluation of safety outcomes, likely assessed by observers/evaluators of the study.
• Animal Study: The "ground truth" was established through direct observation during the study, gross examination at necropsy, and histological analysis of tissues.

8. The sample size for the training set

This question is not applicable. The device is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms.

9. How the ground truth for the training set was established

This question is not applicable. There is no training set for this type of device.

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