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The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.

The provided text is a 510(k) Premarket Notification Submission for a medical device: the "Power Acute Triple Lumen Hemodialysis Catheter." This document is primarily focused on demonstrating "substantial equivalence" of the new device to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a study directly assessing AI performance.

Therefore, many of the specific details requested in your prompt regarding acceptance criteria, AI performance, ground truth establishment, expert adjudication, and MRMC studies are not available in this document because it describes a traditional medical device submission, not an AI/ML-enabled medical device submission.

However, I can extract information related to the device's performance testing and validation as described for a non-AI/ML device.

Here's an analysis based on the provided text, addressing what can be found and noting what is not applicable/present:

Acceptance Criteria and Study for Power Acute Triple Lumen Hemodialysis Catheter

This submission pertains to a traditional medical device (hemodialysis catheter), not an AI/ML-enabled device. As such, the "acceptance criteria" discussed are primarily related to general device performance and safety benchmarks, rather than specific AI performance metrics like sensitivity, specificity, or AUC, or human reader improvement with AI assistance. The "study" refers to bench testing and biocompatibility testing to ensure the device performs as intended and is safe.

1. A table of acceptance criteria and the reported device performance

The document lists various tests performed to ensure the device's safety and performance, demonstrating "substantial equivalence" to a predicate device. The acceptance criteria are implicitly the successful completion of these tests in accordance with recognized standards, showing that the new device performs comparably to or better than the predicate. The "reported device performance" is that it "met the minimum requirements" for these tests.

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

The document describes bench testing and biocompatibility testing. This type of data does not typically involve a "test set" in the context of patient data for AI model validation. The sample sizes for these engineering and biological tests (e.g., number of catheters tested for flow rate, number of samples for chemical tolerance) are not specified in this summary document.

• Data Provenance: Not applicable in the sense of country of origin for clinical data. The tests are laboratory-based and conducted on the manufactured device.
• Retrospective or Prospective: Not applicable for bench/biocompatibility testing.

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

This is not applicable as the document describes a traditional medical device, not an AI/ML device relying on expert-established ground truth from medical images or clinical data. Ground truth for these tests is established by standardized measurements and laboratory methods (e.g., measuring flow rates, observing material reactions).

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

Not applicable. This concept applies to human expert review of medical data, typically for AI model validation, not for the engineering and biocompatibility testing described.

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

No. This is not applicable. This document describes a traditional hemodialysis catheter, not an AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI effect size would be relevant or performed.

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

No. This is not applicable. There is no algorithm mentioned in this device submission.

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

The "ground truth" for the device's performance is established by physical and chemical measurements conducted according to internationally recognized standards (e.g., ISO standards) and FDA-recognized consensus standards. This includes:

• Measured flow rates
• Measured burst pressures
• Observational results of material integrity (kinking, clamping)
• Biological reactions in biocompatibility tests (e.g., cell culture, animal studies for toxicity, hemolysis)

8. The sample size for the training set

Not applicable. This document describes the testing of a physical medical device, not an AI/ML model that requires a "training set" of data.

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

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

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