Search Results

The Wildcat 5F Guidewire Support Catheter (Kittycat 2) is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and, other interventional devices. It may also be used to deliver sàline or contrast.

The Wildcat 5F Guidewire Support Catheter (Kittycat 2) is a 5F sheath and 0.014" guidewire compatible over-the-wire device. It consists of a catheter shaft with handle assembly at the proximal end and an atraumatic distal tip. The catheter is available in a working length of 150 cm. A locking luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.

The provided text describes the regulatory submission for the Wildcat 5F Guidewire Support Catheter (Kittycat 2) and its substantial equivalence to a predicate device. However, it does not contain a detailed study with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance. The document focuses on non-clinical performance testing to demonstrate the device's functionality and safety based on pre-determined product specifications and external standard requirements.

Therefore, many of the requested items cannot be extracted directly from the provided text.

Here is the information that can be extracted or inferred:

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

The document states that "All data fell well within pre-determined product specifications and external standard requirements." However, the specific quantitative acceptance criteria and the exact reported performance values are not detailed in the provided text. The non-clinical tests conducted include:

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

The document does not specify sample sizes for each test. The data provenance is not mentioned, but it refers to "non-clinical testing," which typically implies laboratory-based or in-vitro tests rather than human subject data.

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 as the study described is for a medical device (guidewire support catheter) and involves non-clinical performance testing, not diagnostic or image interpretation tasks requiring clinical expert review for ground truth.

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

This information is not applicable for the type of non-clinical device performance testing described.

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

No such study was conducted or mentioned in the provided text, as the device is a physical medical instrument, not an AI or diagnostic application.

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

This information is not applicable, as the device is a physical medical instrument and does not involve an algorithm.

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

For the non-clinical performance testing, the "ground truth" would be established by the pre-determined product specifications and external standard requirements for each test (e.g., a specific tensile strength value, a certain flexibility parameter, evidence of no leaks, etc.). This is not clinical ground truth.

8. The sample size for the training set

This information is not applicable, as no AI model or algorithm requiring a training set is involved.

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

This information is not applicable, as no AI model or algorithm requiring a training set is involved.

Ask a specific question about this device

The Wildcat 5F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline/contrast.

The Wildcat 5F Guidewire Support Catheter is a 5F sheath and 0.014" guidewire compatible over-thewire device. It consists of a catheter shaft with handle assembly at the proximal end an atraumatic distal tip. The catheter has a working length of 140 cm. A locking luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.

The provided text describes the nonclinical performance data for the Avinger Wildcat 5F Guidewire Support Catheter. It focuses on demonstrating equivalence to a previously cleared device (Wildcat 7F Guidewire Support Catheter) rather than establishing specific acceptance criteria with numerical targets.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of predetermined numerical acceptance criteria against which device performance is measured. Instead, it states that:

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

• Sample Size:
  • For laboratory testing (tensile, torque, coating integrity, compatibility): Not specified.
  • For porcine animal model: Not specified.
• Data Provenance: The document does not specify the country of origin of the data for either the laboratory tests or the animal study.
• Retrospective or Prospective: Not specified, but given the context of design verification testing and animal studies, it is implied to be prospective testing.

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)

Not applicable. This device is a medical instrument (catheter), and its performance evaluation does not involve establishing ground truth from expert interpretation in the way an AI diagnostic device would. The "ground truth" here is the physical and biological performance against established standards and in-vivo functionality.

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

Not applicable. Adjudication methods are typically associated with human-read studies, particularly in the context of diagnostic AI, to resolve discrepancies in expert interpretations. This document describes physical and biological performance tests.

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. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This document describes the nonclinical performance of a guidewire support catheter, not a diagnostic AI system.

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

This question refers to AI algorithm performance. This document describes the performance of a physical medical device. The "standalone performance" of the device is described as its ability to meet specifications in laboratory tests and perform successfully in an animal model.

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

The "ground truth" for this device's evaluation is primarily:

• Engineering Specifications: Pre-determined product specifications for tensile, torque strength, and coating integrity, derived from ISO 10555-1.
• Biocompatibility Standards: Requirements set forth in EN ISO 10993-1.
• In-vivo Functionality: Successful performance in a well-defined porcine animal model representing a discrete vascular bed.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; it's a physical medical instrument. Therefore, there is no "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.

Ask a specific question about this device