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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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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 intraluminal, 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 CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity or specificity thresholds). Instead, the performance claims are qualitative and relate to the device's intended function and safety.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the "in-vitro testing and animal studies." It only refers to "results of in-vitro testing and animal studies."
• Data Provenance: The studies mentioned are "in-vitro testing" and "animal studies." No country of origin is specified, and the studies are inherently prospective in nature (designed and conducted to gather specific data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. Given the nature of "in-vitro testing and animal studies," ground truth would likely be established through direct observation, physiological measurements, or histological analysis, rather than by human expert interpretation in the same way it would be for a diagnostic AI.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method. This type of method (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation of medical images where disagreements need to be resolved. For in-vitro and animal studies, objective measurements or observations form the "ground truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The device described (CrossPoint TransAccess Catheter) is a physical medical device (catheter with ultrasound imaging capability), not an AI algorithm intended for diagnostic interpretation to be used with or without human assistance. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. As noted above, this device is not an AI algorithm. Its performance is related to its physical function and the quality of the ultrasound images it provides, not algorithmic interpretation.

7. The Type of Ground Truth Used

Based on the description of "in-vitro testing and animal studies," the ground truth would likely be established through:

• Direct Observation: For catheter placement and manipulation.
• Physiological Measurements: To assess efficacy and safety in animal models.
• Histological Analysis or Other Pathology: For evaluating tissue effects or confirming findings in animal studies.
• Engineering Measurements/Specifications: For in-vitro performance (e.g., image resolution, catheter flexibility).

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the device is a physical medical device, not a machine learning or AI algorithm 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.

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