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The PRO-PICC ® C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

• Designed for peripheral vein catherization
• Comprised of a polyurethane material
• The lumen is connected to the extensions by a hub with a suture wing for placement.
• Clamps are provided on the extension tubes to prevent air/fluid communication.
• A female luer connector provides the connection for intravenous administration.
• Maximum recommended pressure limit setting 300 psi.
• Maximum indicated power injection flow rate 5cc/sec.

Let's break down the information provided about the Medcomp PRO-PICC® CT device to address your questions.

It's important to note that this document is a 510(k) summary for a medical device which is demonstrating substantial equivalence to a predicate device. This type of submission relies on showing that a new device is as safe and effective as a legally marketed device, rather than proving absolute safety and effectiveness for the first time. Therefore, the "study" described focuses on performance testing against established standards and comparison to a predicate, rather than clinical trials with human subjects in the way an AI-driven image analysis tool might.

Acceptance Criteria and Study Details for PRO-PICC® CT

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

For the PRO-PICC® CT, the "acceptance criteria" are implied by compliance with recognized international standards and the performance of the predicate device. The "reported device performance" is essentially that the device met these standards and performed comparably to the predicate.

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

• Sample Size for Test Set: Not explicitly stated as a "sample size" in the context of clinical trials. The testing refers to objective performance testing of manufactured devices against specifications and standards, not a set of clinical data or patient samples. The number of physical units tested to ensure compliance for each standard (e.g., how many catheters were burst tested for pressure limits) is not provided.
• Data Provenance: The testing was conducted by Medcomp, Inc., a US-based company, for a US FDA submission. The nature of this technical performance testing would be considered prospective, as it's performed specifically for the submission. It's not clinical data, but rather engineering/materials testing.

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 type of information is not applicable to this 510(k) submission.

• The ground truth for this device is based on engineering specifications, material science, and compliance with recognized international standards (ISO standards) for medical devices.
• The "experts" involved would be Medcomp's engineers, quality assurance personnel, and potentially external testing labs, whose qualifications would be in engineering, materials science, and medical device regulations rather than clinical expertise in establishing diagnostic ground truth. No number or specific qualifications are provided in this summary.

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

This is not applicable to this type of device submission. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology readers) where there might be disagreement in establishing ground truth from qualitative data. Here, the "truth" is determined by objective physical measurements and adherence to specified performance metrics.

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 is not applicable. This is a physical medical device (PICC catheter), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies, AI assistance, or human reader improvement are not relevant here.

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

This is not applicable. Again, this is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for the PRO-PICC® CT's performance evaluation is:

• Compliance with International Standards: Specifically ISO 10993-1, ISO 10555-1, ISO 10555-3, and ISO 594-2. The standards themselves define acceptable performance thresholds.
• Engineering Specifications: Such as the 300 psi pressure limit and 5cc/sec flow rate.
• Predicate Device Performance: The previous PRO-PICC®-CT (K081904) serves as the benchmark for demonstrating "substantial equivalence."

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this device. Training sets are used in machine learning for AI/algorithms. This submission is for a physical medical device.

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

This is not applicable for the same reasons as #8.

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