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The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy.

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheters are a safety medical device used for inserting a catheter into a patient's body for the delivery of fluids or drainage of fluids from a patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury. In addition, this device also secures the needle (used to insert the catheter) within the catheter body with either a push button or slide safety mechanism, thus protecting healthcare and other personnel from accidental needle sticks.

The MedSource TrueSafe Blood Control I.V. Safety Catheter is comprised of a sharp needle attached to a needle hub with a catheter attached to a catheter hub. In the catheter hub there is a valve that, when activated, allows for the movement of fluids. In the 'inactivated' state prior to insertion of a male Luer, the movement of fluids is restricted. When the needle is retracted with the push button from the catheter the needle retracts into the body of the catheter and the needle is fully encapsulated.

The MedSource ClearSafe Blood Control I.V. Safety Catheter blood control mechanism is identical to the MedSource TrueSafe Blood Control I.V. Safety Catheter. The only difference in design features is the ClearSafe Blood Control has a slide safety mechanism that retracts the needle into the catheter body. The needle is also fully encapsulated to prevent accidental needlesticks. There is no difference in clinical use between the two models and the use of one over the other depends on user preference.

The MedSource TrueSafe and ClearSafe Blood Control Safety I.V. Catheter gauges are color coded for positive identification and range from 14G to 24G.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. Instead, it describes a medical device, its intended use, comparison with a predicate device, and the various performance and biocompatibility tests it underwent to achieve substantial equivalence for FDA clearance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC study information.
6. Standalone performance information.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering and performance testing, rather than a clinical study evaluating diagnostic or therapeutic efficacy against specific acceptance criteria in a human population.

The performance testing listed (ISO standards, simulated clinical use study) are applied to the device itself to ensure it functions as intended and safely, not typically to evaluate its effectiveness in a diagnostic or treatment context against a clinical ground truth. For example, ISO 10555-5 relates to "Intravascular catheters Sterile and single-use catheters Part 5: One-needle peripheral catheters" to ensure the device meets the physical and functional requirements for such catheters.

The document states: "In summary, based on the indication for use, technological characteristics and performance testing, the differences between The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter and the predicate did not raise new or different questions of safety and effectiveness." This is the conclusion of the 510(k) process, indicating that the device is deemed safe and effective based on its similarity to existing devices and its adherence to relevant performance standards.

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