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The EQUISTREAM™ Iong-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion, and apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters greater than 40cm are intended for femoral vein insertion.

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The provided text describes a 510(k) premarket notification for the EQUISTREAM™ Long-Term Hemodialysis Catheter Family. However, it does not include information about acceptance criteria or a study proving the device meets specific performance metrics in the way that an AI/ML device submission would.

The document primarily focuses on demonstrating substantial equivalence to an existing predicate device (HemoSplit® Long-Term Hemodialysis Catheter, K030020). The concept of substantial equivalence in 510(k) means that the new device is as safe and effective as a legally marketed predicate device. This is typically achieved by showing similar technological characteristics, intended use, and safety/performance testing without raising new questions of safety or effectiveness.

Therefore, I cannot provide the requested information as it pertains to an AI/ML device's performance study with acceptance criteria, sample sizes, ground truth establishment, or expert reviews. The provided text is for a traditional medical device (catheter) regulated under the 510(k) pathway, which primarily relies on comparison to a predicate device rather than de novo performance studies with acceptance criteria in the context of AI/ML.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Device Performance: These are not explicitly stated for the EQUISTREAM™ catheter in a quantifiable manner (e.g., sensitivity, specificity, accuracy). The document states "the subject EQUISTREAM™ catheters met the minimum requirements that are considered adequate for its intended use" and "Based on the indications for use, technological characteristics, and safety and performance testing, the subject EQUISTREAM™ catheters met the minimum requirements that are considered adequate for its intended use and is substantially equivalent...". This implies that the device performed comparably to its predicate in relevant tests, but the specific metrics are not detailed.
• Sample Size (Test Set) & Data Provenance: Not applicable in this context. The "test set" for a traditional device like this would involve bench testing for material properties, flow rates, durability, etc., not a clinical data set for algorithm performance.
• Number of Experts & Qualifications: Not applicable. Ground truth establishment with experts is a concept for AI/ML device validation.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Study: Not applicable, as this is for evaluating human performance with and without AI assistance.
• Standalone Performance: While the catheter's standalone performance was assessed (e.g., flow rates, material compatibility), these are not presented with quantitative "acceptance criteria" and results in the provided summary.
• Type of Ground Truth: Not applicable in the AI/ML sense. The "ground truth" for a catheter would be its physical and mechanical properties confirmed by engineering and material tests, and its clinical performance monitored post-market.
• Sample Size (Training Set): Not applicable, as this is not an AI/ML device.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (catheter) demonstrating substantial equivalence to a predicate, not an AI/ML device submission with performance metrics against acceptance criteria.

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