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The LifeShield® Latex-Free Microbore Extension Set is intended for the delivery of fluids from a container to a patient's vascular system.

The LifeShield® Latex-Free Microbore Extension Set consists of DEHP-plasticized polyvinyl tubing with a secure lock male adapter and air filter assembly on one end and locking female Luer adapter with removable CLAVE® Connector on the other end.

The provided text is a 510(k) summary for the LifeShield® Latex-Free Microbore Extension Set. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for novel devices involving performance metrics.

Here's why and what information is available:

• This is a Special 510(k) submission, which is generally used for modifications to a manufacturer's own legally marketed device. In such cases, the primary focus is on demonstrating that the modified device remains substantially equivalent to the predicate device, not necessarily on establishing new performance criteria or conducting extensive clinical studies with new acceptance criteria.
• The document explicitly states: "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Fluid Delivery Tubing." This indicates that there aren't pre-defined regulatory performance benchmarks that the device needs to meet with specific acceptance criteria.
• The "Statement of Safety and Effectiveness" simply declares that the device "meets the finances of the states the described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate LifeShield® Extension Sets." This reiterates the focus on substantial equivalence rather than fulfilling specific performance metrics against acceptance criteria.

Therefore, I cannot populate the requested table or sections related to a study proving acceptance criteria due to the absence of that information in the provided text.

The document is a submission to the FDA for market clearance based on substantial equivalence, which is a different process than demonstrating performance against established acceptance criteria for a novel device or a device with new performance claims.

Summary of available information (and absence of others):

1. Table of acceptance criteria and reported device performance:
* Not Applicable / Not Provided. The document does not describe specific acceptance criteria (e.g., flow rate, pressure resistance, leakage rate with defined thresholds) or a study reporting performance against such criteria. The submission is based on substantial equivalence to predicate devices, implying that their performance characteristics are considered acceptable.

2. Sample size used for the test set and data provenance:
* Not Applicable / Not Provided. No "test set" in the context of performance evaluation or clinical study is mentioned. The submission is based on device characteristics comparison to predicate devices, not on data from a test set of patients or samples.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
* Not Applicable / Not Provided. No ground truth establishment or expert review for a test set is discussed.

4. Adjudication method for the test set:
* Not Applicable / Not Provided. No test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
* Not Applicable / Not Provided. This type of study is irrelevant for a fluid delivery tubing submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not Applicable / Not Provided. This device is hardware; the concept of an "algorithm only" performance study is not relevant.

7. The type of ground truth used:
* Not Applicable / Not Provided. No ground truth for performance evaluation is mentioned. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:
* Not Applicable / Not Provided. No "training set" in the context of an AI/ML algorithm or clinical data is mentioned.

9. How the ground truth for the training set was established:
* Not Applicable / Not Provided. See above.

Key takeaway: This 510(k) submission relies on demonstrating substantial equivalence to existing, legally marketed devices. It does not present a study with specific acceptance criteria that the device's performance was measured against, as would be common for novel, performance-driven devices. The FDA clearance letter reinforces this by focusing on regulatory classification and labeling requirements based on the substantial equivalence determination.

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