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The Approach CTO Microwire Guide is intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature and is also indical for the intraluminal placement of percutaneous catheters or other therapeutic devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

The Approach® CTO Microwire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a core mandril and a distal spring coil. The Approach® CTO Microwire Guide is available with an outside diameter of 0.014 inches and lengths ranging from 135 - 300 centimeters. The flexible tip portion of the wire guide is straight with tip loads ranging from 6 - 25 grams.

The Approach® CTO Microwire Guide is supplied with an insertion cannula which facilitates the insertion of the wire guide through valve assemblies.

The Approach® CTO Microwire Guide is a packaged, sterile device intended for single patient use.

Here's a breakdown of the acceptance criteria and study information for the Approach CTO Microwire Guide, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

This device is not an AI/ML powered device, so some of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training ground truth was established) are not applicable as they relate specifically to AI device evaluation.

1. Sample size used for the test set and the data provenance:

   • Animal Model: The document states "All (100%) of the test articles evaluated..." implying multiple devices were tested, but a specific number "n" for the test set is not provided.
   • Cadaver Model: Similar to the animal model, "All test articles evaluated..." is mentioned, but a specific number for the test set is not provided.
   • Data Provenance:
     • Animal Model: Prospective in vivo study.
     • Cadaver Model: Prospective ex vivo study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a physical medical device, and its performance was evaluated through direct observation and measurements in animal and cadaver models, not by expert interpretation of data to establish a "ground truth" in the AI sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance was assessed based on observable and measurable physical parameters in the animal and cadaver models.

4. 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: Not applicable. This is not an AI device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

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

   • Animal Model: Direct observation of device performance (preparation, introduction, pushability, trackability, flexibility, radiopacity, withdrawal, reintroduction, interaction with supporting devices) and absence of adverse events (perforations or dissections) in a simulated clinical environment.
   • Cadaver Model: Direct observation of device performance (preparation, introduction, pushability, trackability, radiopacity, interaction with supporting devices) and successful navigation/crossing of stenotic lesions.

7. The sample size for the training set: Not applicable. This is not an AI device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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