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Percutaneous insertion kit designed to provide physicians with a dual wire technique for use with Spire Biomedical, Inc.'s Pourchez XpressO™ and Pourchez RetrO™ catheters only.

The "SafeTrac Dual Wire Insertion Kit" provides an alternative method for chronic hemodialysis catheter placement by using an over the wire technique dilating and inserting either the Pourchez RetrO and XpressO catheters over a guidewire percutaneously. The introducers consist of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist dilation. The hub proximal end has a female luer lock configuration. An optional hub collar may be used to attach the dilator to the catheter. The kits come with two quidewires, two 5F dilators, a 6F, 14F and 16F sheath/dilators in five different lengths. Each kit consists are to be supplied sterile and for single use only. The kits are to be sold in boxes of five.

The provided document does not describe an acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, the document is a 510(k) premarket notification summary for a medical device called the "SafeTrac Dual Wire Insertion Kit." The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove performance against specific acceptance criteria through a performance study.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Data: The document explicitly states under the "Performance Data" section: "There are no performance criteria for the devices to be included with Spire Biomedical, Inc.'s SafeTrac Dual Wire Insertion Kit." This means no specific performance metrics (like accuracy, sensitivity, specificity, etc.) were established or tested against.
• Substantial Equivalence, Not Performance Study: The entire submission is focused on demonstrating that the SafeTrac Dual Wire Insertion Kit is "substantially equivalent" to existing, legally marketed devices (predicate devices). This typically involves comparing design, materials, intended use, and technological characteristics, rather than conducting a new performance study with clinical endpoints.
• No "Device Performance" Reported: Since no performance study was conducted or acceptance criteria defined, there is no "reported device performance" to tabulate.
• No "Test Set," "Training Set," or "Ground Truth": These concepts are relevant for studies that involve data analysis, machine learning algorithms, or diagnostic performance evaluation, which are not applicable to this 510(k) submission for an insertion kit.
• No "Experts" for Ground Truth or Adjudication: As there's no data-driven study, there's no need for experts to establish ground truth or for adjudication methods.
• No "MRMC Comparative Effectiveness Study" or "Standalone Performance": These types of studies are for evaluating the effectiveness or diagnostic accuracy of a device, which is not the scope of this particular submission.

In summary, the provided document focuses on regulatory clearance through substantial equivalence, not on a detailed performance study with acceptance criteria.

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