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The Bard® AquaGuide™ Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.

The Bard® AquaGuide™ Ureteral Access Sheath is a twocomponent ureteral dilation system which contains multiple lumens for injection and aspiration of fluids as well as passage of endoscopes and related instruments. The auptram consists of a hydrophilic-coated introducer with female luer connector and a hydrophilic-coated dual-lumen sheath with multi-function access hub. The system is available in Introducer sizes 10-13, Sheath sizes 12-16 and lengths: 25 - 55cm.

The submitted text is a 510(k) summary for the Bard® AquaGuide™ Ureteral Access Sheath. It describes the device, its intended use, and states that performance data was submitted, but does not provide details on specific acceptance criteria or the results of a study demonstrating the device meets those criteria.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: Comprehensive acceptance criteria (e.g., specific dimensions, tensile strength, flow rates, biocompatibility test results, etc.) and quantitative or qualitative results against these criteria are not included.

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, the performance data would typically be generated from internal testing, possibly in vitro or bench testing. There is no mention of human clinical data or animal studies as a "test set" in the context of device performance testing. The document states it's "constructed of biocompatible materials," implying relevant testing was done, but details are absent.

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

• Number of Experts: Not applicable/Not specified. The performance data mentioned (biocompatibility, reduced hypervolemia) typically doesn't rely on expert ground truth in the same way an AI diagnostic device would. It's based on objective measurements and scientific principles.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/Not specified. As mentioned above, the type of "test set" for this device's performance data likely doesn't involve 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:

• MRMC Study: No. This device is a medical instrument (ureteral access sheath), not an AI diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For biocompatibility, the ground truth would be established through standardized in vitro and in vivo biocompatibility testing (e.g., ISO 10993 series). For "reducing the potential for hypervolemia," the ground truth would likely be established through fluid dynamics testing and potentially animal models demonstrating the efficacy of the additional lumen for fluid aspiration. The document does not provide details on these.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established:

• Ground Truth for Training Set: Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device and lacks the kind of detailed performance study information typically requested for AI/ML-based devices. It confirms the device's identity, intended use, and regulatory classification, but it does not present acceptance criteria or detailed study results in the format requested. The "Performance Data Summary" section is very brief and high-level.

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The Bard® AquaGuide™ Ureteral Conduit is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.

The Bard® AquaGuide™ Ureteral Conduit is a two-component ureteral dilation system which contains multiple lumens for injection and aspiration of fluids as well as passage of endoscopes and related instruments. The system consists of a hydrophilic-coated introducer with female luer connector and a hydrophilic-coated dual-lumen sheath with multi-function access hub. The system is available in three lengths: 25, 35 and 55cm and with either a 10Fr. Introducer with 12-14 Fr. sheath or a 12 Fr. Introducer with 14-16 Fr. sheath.

The provided text describes a 510(k) summary for the Bard® AquaGuide™ Ureteral Conduit, focusing on its substantial equivalence to a predicate device, the Applied Medical Ureteral Access Sheath Set. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of an AI-powered device.

The information provided is for a traditional medical device (a ureteral conduit), and the regulatory submission is based on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and intended use. Performance data summary in this context refers to the comparison of features, not a clinical study with quantitative performance metrics for AI.

Therefore, I cannot fulfill the request as it asks for details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI device performance, which is not present in the provided document.

Here's why the provided text doesn't fit the request:

• No AI Device: The device described is a physical medical instrument (Ureteral Conduit), not an AI-powered diagnostic or therapeutic system.
• No Quantitative Performance Metrics: The "Performance Data Summary" is a table comparing features like size ranges and materials to a predicate device. It does not include acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or reported device performance in those terms.
• No Clinical Study Details: There is no mention of a study design, sample sizes (for test or training sets), expert adjudication, ground truth establishment, or multi-reader multi-case studies, which are all typically associated with proving the performance of AI algorithms.
• Regulatory Pathway: The K030438 submission is a 510(k), which relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials to prove novel performance metrics (which would be more common for an AI device).

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