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The Power-TrialysisTM Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Power-Trialysis™ Short-Term Dialysis catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into three separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The distal (purple) lumen is completely independent from the two dialysis lumens and may be used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The distal lumen can also be accessed for blood draws and infusion of medications.

The provided text describes a 510(k) premarket notification for a medical device called the Power-Trialysis Short-Term Dialysis Catheter (K133456). This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K083675) rather than establishing novel performance criteria for a new type of device. As such, the structure of the provided information does not perfectly align with a typical AI/software device study seeking to establish performance against defined acceptance criteria.

The "acceptance criteria" here are generally that the new device performs as safely and effectively as the predicate device. The study described is a series of engineering and performance tests comparing the subject device to the predicate device to confirm this substantial equivalence.

Here's an attempt to structure the information based on your request, with clarifications where the provided text doesn't directly map to the question:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical catheter, the "acceptance criteria" are generally based on meeting the performance established by the predicate device and relevant industry standards. The reported performance confirms these criteria were met.

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many catheters were tested for hemolysis or burst strength). It refers to "verification and validation activities" and "performance data" but does not quantify the number of units tested.

• Sample Size for Test Set: Not explicitly stated for each individual test. Implied to be sufficient for engineering validation studies following design controls (21 CFR §820.30).
• Data Provenance: The studies were conducted by Bard Access Systems, Inc. in the US, as part of their 510(k) submission. These are prospective engineering and performance tests on manufactured devices, not retrospective clinical data.

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

This type of information is generally not applicable to a 510(k) submission for a physical device like a catheter. The "ground truth" for the performance tests (e.g., flow rate, burst pressure, tensile strength) is based on measurable physical properties and objective engineering standards (e.g., ISO, ASTM). The "experts" involved would be the engineers, technicians, and quality control personnel conducting and reviewing these tests, whose qualifications would be in engineering, materials science, or related fields. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable in the context of physical performance testing against objective standards. The results of tests like burst pressure or hemolysis are quantitative and compared directly to predetermined specifications or standards, without the need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human reader performance is being evaluated with and without AI assistance. The Power-Trialysis Short-Term Dialysis Catheter is a physical medical device, not a diagnostic AI tool.

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

Not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on:

• Objective Engineering Standards: Adherence to established international and national standards (e.g., ASTM F1841, ISO 10555-1, ISO 10993-7).
• Predicate Device Performance: Performance data from the legally marketed predicate device (K083675) serves as a benchmark for substantial equivalence.
• Design Specifications: Internal design requirements and specifications for the catheter's physical and functional properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and the concept of a "training set" is generally used for machine learning models, not for engineering validation of a catheter. The manufacturing process for these devices would involve process validation and quality control, which are distinct from machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no "training set" in the machine learning sense, there is no ground truth established for it.

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