Search Results

The SIDEKICK® and USHER® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.

The SIDEKICK® and USHER® Support Catheters are single lumen catheters with a standard luer fitting hub and separate attachable hemostatic valve to support the CROSSER® CTO Recanalization Catheters 14S and S6. The product hub identifies SD for SIDEKICK® Catheter, USH for USHER® Catheter, A for Angled and T for Tapered in addition to the sheath profile and working length in centimeters. A guidewire introducer is provided to facilitate the guidewire passage through the optional hemostatic valve. The guidewire introducer shaft color matches the shaft color of the recommended support catheter.

The SIDEKICK® Catheter is available in straight, angled, tapered and non-tapered configurations in 70cm and 110cm working lengths. The USHER® Catheter is tapered and is available in straight and angled configurations in 83cm and 130cm working lengths. The SIDEKICK® and straight USHER® Catheters have a single radiopaque marker 1mm from the distal tip. The angled USHER® Catheter configurations have three radiopaque markers at the distal tip for enhanced visualization of the catheter tip and angle under fluoroscopy. The third proximal radiopaque marker is located 15mm from the distal tip.

The GEOALIGN® Marking System has been added to the device. The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.

The provided text describes a 510(k) premarket notification for the SIDEKICK® and USHER® Support Catheters, focusing on the addition of the GEOALIGN® Marking System. This is a medical device submission, and the "acceptance criteria" and "device performance" mentioned in the request refer to the performance testing of the device for regulatory approval, not typically the performance of an AI algorithm or a clinical study in the traditional sense.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table with acceptance criteria thresholds and discrete performance values in the way one might expect for an AI algorithm. Instead, it describes general performance testing and concludes that the device is "comparable" and "substantially equivalent" to the predicate device.

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

The document does not specify the exact sample sizes used for each of the performance tests (e.g., how many catheters were tested for marking legibility, durability, or dimensions). It refers generally to "nonclinical tests." The data provenance is internal testing performed by the manufacturer, Bard Peripheral Vascular, Inc., in the USA (Tempe, Arizona). These are laboratory and engineering tests, not clinical data from patients. The study is not a clinical study; it's a non-clinical, benchtop performance evaluation.

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

This information is not applicable to the type of testing described in the document. The "ground truth" here is defined by engineering specifications, measurement standards, and regulatory requirements (e.g., ISO 10993 for biocompatibility), not by expert consensus on clinical data. No "experts" were used in the sense of clinical reviewers to establish ground truth for a test set.

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

This is not applicable. The tests performed are objective, measurable non-clinical tests (e.g., dimensional measurements, durability tests, biocompatibility assays). There is no "adjudication" in the sense of conflicting expert opinions on a clinical outcome.

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 document is for a physical medical device (support catheters), not an AI algorithm. Therefore, no MRMC study or assessment of human readers with/without AI assistance was performed or described.

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

Not applicable. This document is for a physical medical device (support catheters), not an AI algorithm.

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

The "ground truth" for the performance tests is based on:

• Engineering specifications and design requirements: For dimensional accuracy, legibility, and durability.
• Established scientific and regulatory standards: Such as ISO 10993-1:2009 CORR 1 for biocompatibility.

8. The sample size for the training set:

Not applicable. This document describes the testing of a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as there is no AI algorithm training set.

Ask a specific question about this device

The Sidekick® and Usher® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.

The Sidekick® and Usher® Support Catheters are single lumen catheters with a standard luer fitting hub and separate attachable hemostatic valve. The catheters are recommended to support the Crosser® CTO Recanalization Catheters 14S/14P and S6.

The Sidekick® Support Catheter is available in straight, angled, tapered and non-tapered configurations in 70cm and 110cm effective lengths. The Usher® Catheter is tapered and is available in straight and angled configurations in 83cm effective lengths. The Sidekick® and straight Usher® Catheters have a single radiopaque marker 1mm from the distal tip. The angled Usher® Support Catheter configurations have three radiopaque markers at the distal tip for enhanced visualization of the catheter tip and angle under fluoroscopy. The most proximal radiopaque marker is located 15mm from the distal tip.

The product hub identifies SD for Sidekick® Catheter, USH for Usher® Catheter, A for Angled and T for Tapered; in addition to the sheath profile and effective length in centimeters. A guidewire introducer is provided to facilitate the guidewire passage through the optional hemostatic valve. The guidewire introducer shaft color matches the shaft color of the recommended support catheter.

The provided text describes the Sidekick® and Usher® Support Catheters and their 510(k) submission for substantial equivalence. It outlines various performance tests conducted to demonstrate their safety and effectiveness compared to predicate devices. However, the document does NOT contain information related to an AI/ML powered device, therefore no information about acceptance criteria or studies based on AI model performance are relevant.

Table of Acceptance Criteria and Reported Device Performance

The document describes several in vitro tests and biocompatibility tests conducted, and it generally states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Sidekick® and Usher® Support Catheters are comparable to the predicate devices and performs at least as safely and effectively as the legally marketed device." and that the devices "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leak rate) and the reported device performance values against these criteria are not detailed in the provided 510(k) summary. The document simply lists the types of tests performed.

The study proving the device meets acceptance criteria appears to be a series of in vitro performance and biocompatibility tests, as well as shelf-life stability testing. The document states that these tests were performed "Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures" and "in accordance with ISO 10993-1:2009".

Regarding the specific questions about AI/ML device testing criteria:

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

   • This information is not applicable as the document describes a traditional medical device (catheter), not an AI/ML powered device that would use a test set of data. The "test set" in this context refers to the physical units of the catheters and packaging tested in the various in vitro and biocompatibility studies. The specific number of units tested for each in vitro test is not provided. The provenance of the data is that it was generated from "in vitro" testing and "in-vivo" biocompatibility testing (referring to animal studies, typically).

2. 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 device is not an AI/ML powered diagnostic or image analysis tool. Ground truth is not established by human experts in this context. The "ground truth" for catheter performance is defined by engineering specifications, regulatory standards, and established test methods.

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

   • This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert panel reviews for AI/ML models to resolve discrepancies or establish ground truth. For physical device testing, the outcome is typically pass/fail based on objective measurements against pre-defined engineering specifications.

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:

   • This information is not applicable. MRMC studies are designed to evaluate the impact of AI on human reader performance for diagnostic tasks. This device is a catheter, not an AI system for clinicians.

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

   • This information is not applicable. This device is a physical catheter, not an algorithm.

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

   • For this traditional device, the "ground truth" is based on engineering specifications, established regulatory standards (e.g., ISO, ASTM), and internal test protocols designed to ensure the device performs as intended and is safe. The comparison is made against the performance of predicate devices.

7. The sample size for the training set:

   • This information is not applicable. As this is not an AI/ML device, there is no "training set."

8. How the ground truth for the training set was established:

   • This information is not applicable, as there is no training set for a device of this nature.

Ask a specific question about this device