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The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intra-luminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.

The subject device (CrossPoint TransAccess Catheter) is substantially equivalent in intended use and/or method of operation to the original CrossPoint TransAccess Catheter (K013363).

This device is a medical catheter and not an AI/ML device. Therefore, the requested information regarding AI/ML device performance metrics, such as ground truth, expert adjudication, sample sizes for training/test sets, and MRMC studies, is not applicable. The provided text is a 510(k) summary for a medical device called the CrossPoint® TransAccess® Catheter. This document asserts the device's substantial equivalence to a predicate device and reports on in-vitro testing.

Here's the breakdown of the information relevant to the device as presented in the document:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided document. The document only mentions "in-vitro testing."
• Data Provenance: Not specified. The testing was "in-vitro," meaning conducted in a controlled environment outside of a living organism, but no details on where or how these tests specifically were conducted are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable to the provided document. The device's performance was assessed through in-vitro testing, not against expert ground truth derived from clinical images or patient data.

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

• This information is not applicable. The evaluation was based on in-vitro testing outcomes, not on subjective assessments requiring expert adjudication.

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

• This information is not applicable. The device is a physical catheter, not an AI or imaging interpretation software. No MRMC study was conducted or mentioned in this context.

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

• This information is not applicable. The device is a physical medical instrument, not a standalone algorithm.

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

• The concept of "ground truth" as typically used for AI/ML performance evaluation (e.g., expert consensus interpretations, pathology results for imagery) is not directly applicable here. The "ground truth" for this device's performance would be engineering specifications and functional benchmarks met during in-vitro testing to demonstrate its ability to facilitate catheter placement and provide ultrasound images.

8. The sample size for the training set

• This information is not applicable. The device is a physical catheter, not an AI/ML model that requires a training set.

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

• This information is not applicable, as there is no training set for a physical medical device.

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