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The Spectrum® Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. The device is a short-term use catheter, supplied sterile and intended for one-time use.

The nominal 7-French Triple Lumen Spectrum® Central Venous Catheter with Hydrophilic Coating is a polyurethane catheter with three non-communicating vascular access lumens. The coating is impregnated with the antimicrobials minocycline and rifampin (avg. concentration 520 ug/cm and 470 ug/cm respectively) and has a hydrophilic coating consisting of polyacrylamide and polyvinylpyridone to enhance insertion.

This document is a 510(k) summary for the Cook Spectrum® Central Venous Catheter, which primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It briefly mentions test data but does not contain a detailed study report that describes the acceptance criteria and a study proving the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered and what cannot:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not explicitly stated in the format of direct performance against acceptance criteria.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.
• Retrospective or Prospective: Not mentioned.

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

• This information is not provided as the document does not detail a clinical study with expert-established ground truth.

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

• Not applicable/Not mentioned, as a clinical study with adjudication is not 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 MRMC comparative effectiveness study is mentioned. This device is a Central Venous Catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable/Not mentioned. The "Test Data" section refers to bench testing and in-vitro testing ("HPLC and zone of inhibition") rather than clinical ground truth for diagnostic performance.

8. The sample size for the training set

• Not applicable/Not mentioned, as this is not an AI/machine learning device.

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

• Not applicable/Not mentioned.

Summary of available information related to testing:

The document states:

• "The device has undergone testing that provides reasonable assurance of safety and effectiveness for its intended use."
• "Testing includes: biocompatibility, tensile, vacuum and pressure, flow rate, HPLC and zone of inhibition."

This indicates that various types of bench and in-vitro testing were performed to evaluate physical properties, material compatibility, and antimicrobial properties. However, it does not detail the specific acceptance criteria for these tests or the results in a comparative table as requested for an AI model's performance. The review process was primarily focused on substantial equivalence to an existing predicate device (Cook ABRM Central Venous Catheter, K950118), with the main difference being the addition of a hydrophilic coating.

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