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The MAC™Two-Lumen Central Venous Access Device with ARROWg+ard Blue® permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

The proposed device is a modification to Arrow's Two-Lumen Central Venous Access Kit with Integral Hemostasis Valve/Side Port, with the addition of ARROWg" ard Blue antimicrobial surface treatment. The proposed device was Arked to help provide protection against device-related infections. It is not intended to help provise a treatment for existing infections, nor is it indicated for long-term use.

The catheterization kit components are configured in a high-impact polystyrene (HIPS) tray, sealed with a Tyvek® lidstock, and sterilized.

Here's an analysis of the provided text, focusing on the absence of information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance, and then answering the specific questions based on the available text:

The provided text, a 510(k) summary for a medical device called "MAC™ Two-Lumen Central Venous Access Kit with ARROWg+ard Blue®," does not contain explicit "acceptance criteria" for device performance in the way typically expected for a performance study. Nor does it describe a study specifically designed to prove that the device meets such acceptance criteria with quantitative results against those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "performance tests" listed are a series of laboratory and in-vitro tests conducted to ensure the modified device (with the ARROWg+ard Blue® coating) performs similarly to its predecessors and meets general safety and effectiveness standards, rather than proving performance against predefined clinical or quantitative acceptance thresholds specific to its intended use and antimicrobial claim.

The key points from the document regarding "performance" are:

• Intended Use: "The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use." This explicitly states that clinical data for the antimicrobial efficacy in vivo was not collected or submitted as part of this 510(k).
• Performance Tests: A list of 14 tests is provided (tensile, leak, elongation, flow rate, priming volume, flex, burst, in vitro efficacy zone of inhibition, in vitro safety elution profile, hemolysis, fatigue life, stability, and biocompatibility).
• Conclusions: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices."

Therefore, the answers to your questions will largely reflect the absence of a detailed performance study against explicit acceptance criteria in this submission.

Here's the breakdown of the information requested, based only on the provided text:

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

Specific tests performed included:

1. Tensile
2. Leak
3. Elongation
4. Flow Rate with Catheter
5. Flow Rate without Catheter
6. Priming Volume
7. Flex
8. Burst
9. In vitro efficacy zone of inhibition
10. In vitro safety elution profile
11. Hemolysis
12. Fatigue life testing
13. Stability tests
14. Biocompatibility tests

Regarding antimicrobial claim: "Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device." |

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 for Test Set: Not specified in the provided text for any of the listed performance tests.
• Data Provenance: The tests are described as "laboratory tests" and "in vitro" tests. No country of origin is specified for these tests, though the submitting company is based in Reading, Pennsylvania, USA. The data would be considered prospective for these specific tests, as they were conducted as part of the device submission.

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)

• Not applicable/Not specified. The listed performance tests are primarily objective physical and chemical measurements rather than requiring expert interpretation for ground truth.

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

• Not applicable/None specified. The types of tests listed (e.g., tensile strength, leak, flow rate) typically have objective pass/fail criteria determined by measurement, rather than relying on an adjudication process involving multiple human observers.

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 was done or mentioned. This type of study is relevant for diagnostic imaging devices where human interpretation is a key component, which is not the case for this central venous access device.

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

• Not applicable. This device is a physical medical device (catheter kit) and does not involve an algorithm or AI.

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

• For the performance tests mentioned (tensile, leak, flow rate, etc.), the "ground truth" would be the direct physical or chemical measurements obtained from the tests themselves, compared against engineering specifications or established standards for intravascular catheters.
• For the antimicrobial claim, the document explicitly states: "Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device." This indicates that clinical outcomes data (which would be the ultimate ground truth for an antimicrobial claim) were not used in this submission. In vitro efficacy (zone of inhibition) and in vitro safety (elution profile) tests were performed in its place for the antimicrobial aspect.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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