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The PowerHohn" and PowerLine™ Catheters are intended for short or long term access to the central venous system for intravenous therapy and blood sampling.

PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.

• The PowerHohn" and PowerLine™ Catheters are open-ended radiopaque polyurethane catheters.
• Catheter size is 6 Fr DL with 50 cm (PowerLine) or 40 cm (PowerHohn) usable length.
• The catheter has a reverse taper design.
• Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point.
• Catheters are provided sterile in basic radiology configurations.
• Purple colorants were added to the catheter materials to provide the cath appearance that allows the end user to differentiate the PowerHohn" and PowerLine other CVC catheters.
• The catheter extension leg. junction and clamp ID tag were printed with markings to identify the catheter as PowerHohn" and PowerLine" and to include information to facilitate proper use of the device.

The provided text is a 510(k) summary for a medical device, the 6 Fr DL PowerHohn™ and PowerLine™ Catheter. It is a submission for marketing clearance, not a study report detailing specific performance metrics against acceptance criteria. Therefore, much of the requested information, particularly quantitative data regarding accuracy, sample sizes, and ground truth establishment, is not present.

However, based on the submission, I can infer and extract the following:

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

The document does not provide a specific table of numerical acceptance criteria or detailed performance results in the way one might expect from an AI/ML device study. Instead, it states that the device meets "predetermined performance acceptance criteria" and demonstrates "substantial equivalence" to predicate devices. This implies that the acceptance criteria were qualitative and based on standards and comparison to existing, cleared devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission mentions "design verification testing" and "performance data," but does not detail the sample sizes for these tests, the type of data (e.g., in-vitro, in-vivo animal, human), or its provenance. This is typical for a 510(k) for a physical medical device where the focus is on engineering and biological testing, rather than clinical efficacy studies often seen with AI/ML devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided in the document. For a medical device like a catheter, "ground truth" as conceptualized for AI/ML performance assessment (e.g., expert consensus on image interpretation) is not relevant. The "ground truth" would be established by objective measurements and standardized testing procedures (e.g., mechanical strength, flow rates, biocompatibility assay results).

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

This information is not applicable and therefore not provided. Adjudication methods like "2+1" are used in AI/ML studies to resolve discrepancies in expert interpretation of data. For a physical device, performance is evaluated against predefined specifications through engineering and biological testing, not subjective interpretation.

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

This information is not applicable and therefore not provided. MRMC studies are specific to AI/ML devices that assist human interpretation (e.g., radiologists reading images). This device is a physical catheter, not an AI/ML diagnostic tool, and therefore would not involve human readers in this context.

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

This information is not applicable and therefore not provided. This device is a physical catheter, not an algorithm. Standalone performance refers to the performance of an AI algorithm without human intervention.

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

The document implicitly refers to "ground truth" as the results derived from standardized engineering tests and biological evaluations against pre-defined specifications and regulatory requirements. For example:

• Biocompatibility: Results from ISO 10993 tests.
• Physical properties: Measurements of properties like flow rate, pressure limits, material strength, radiopacity.
• Sterility: Results of sterilization validation as per AAMI/ANSI/ISO 11135.

These are objective, measurable outcomes, rather than subjective interpretations by experts.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable and therefore not provided. As above, this device does not involve a training set.

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