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The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.

The Double Flexible Tipped Wire Guides are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The Double Flexible Tipped Wire Guides are wire guides with a flexible distal and proximal end. Double Flexible Tipped Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

The Double Flexible Tipped Wire Guides, subject of this submission, have been modified from the predicate device, Heavy Double Flexible Tipped Wire Guide (K150802), to include additional lengths ranging from 30 to 260 centimeters, additional outside diameters ranging from 0.018 to 0.038 inches, and additional curve radii ranging from 0 to 3 millimeters.

The Double Flexible Tipped Wire Guides are manufactured using a stainless steel core wire, and stainless steel coils. Some configurations include an exterior coating on the coils.

The modifications to the Double Flexible Tipped Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures.

The Double Flexible Tipped Wire Guides are packaged, sterile devices intended for single use.

The provided text describes the Double Flexible Tipped Wire Guides. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each test mentioned (e.g., number of wire guides tested for fracture, tensile, etc.). It only states that the various tests were "performed" and that "all test articles evaluated" met acceptance criteria for the animal model.

Data provenance is not explicitly stated as retrospective or prospective, nor are countries of origin for the data. The tests are described as being performed "to demonstrate that the Double Flexible Tipped Wire Guides met applicable design and performance requirements."

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

This document does not describe a study involving human experts establishing ground truth for a test set. The evaluation is focused on the physical and biological performance of the medical device itself through standardized engineering and biocompatibility tests, and an animal model.

4. Adjudication method for the test set

Not applicable. This was not a study involving human interpretation or adjudication of results. The acceptance criteria were met based on direct measurements and observations during testing.

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

Not applicable. This is a medical device (wire guides) for diagnostic and interventional procedures, not an AI-assisted diagnostic tool. Therefore, no MRMC comparative effectiveness study involving human readers and AI assistance was conducted or would be relevant.

6. 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.

7. The type of ground truth used

The "ground truth" for the performance of the device was established by:

• Standardized Test Methods: Adherence to established international standards (BS EN ISO 11070:2014, BS EN ISO 10993-1:2009) and FDA guidance documents (FDA Coronary and Cerebrovascular Guidewire Guidance (1995)).
• Pre-determined Acceptance Criteria: Specific criteria were set for each test, and the device's performance was compared against these criteria.
• Acute Performance Evaluation in an Animal Model: This constitutes a form of "ground truth" reflecting real-world physiological conditions for device functionality.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

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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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