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The MedSource CathMed IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV 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 CathMED IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV 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.

Each MedSource CathMED IV Catheter is comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, Teflon catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The MedSource CathMED IV Catheter components combine for an ergonomic design.

The device inserts a catheter intravenously by inserting a sharp needle with an over-theneedle catheter. Once the needle and catheter have been passed into a vein the catheter can be advance off the needle is the needle is removed while the catheter remains in the vein for short term use to sample blood or administer fluids.

The MedSource CathMED IV Catheter gauges are color coded for positive identification and range from 14G to 24G

ORANGE = 14G GREY = 16G GREEN = 18G PINK = 20G BLUE = 22G YELLOW = 24G

This looks like a 510(k) summary for a medical device called the MedSource CathMED IV Catheter. The document asserts substantial equivalence to a predicate device (MedSource IV Safety Catheter, K131555).

Based on the provided text, the device itself (MedSource CathMED IV Catheter) is an intravascular catheter, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., sample size for test set, number of experts for ground truth, MRMC studies) are not applicable to this document. The document focuses on performance testing and biocompatibility for a physical medical device.

Therefore, I cannot directly provide the information requested in your prompt as it pertains to AI/ML device testing criteria. However, I can extract the relevant performance data and study information as presented for this physical medical device.

Here's what can be extracted from the document regarding the device's performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance standards and general requirements for intravascular catheters. It doesn't present specific quantitative acceptance criteria with corresponding performance data in a tabular format as would be expected for an AI/ML device. Instead, it indicates compliance with recognized standards.

2. Sample size used for the test set and the data provenance: Not applicable for this type of device and submission. The tests are for physical properties and materials, not for diagnostic accuracy on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing typically refers to objective measurements against established engineering and material standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical performance testing, the "ground truth" would be the objective measurement results conforming to the specifications outlined in the referenced ISO and USP standards. For biocompatibility, it's a conformance statement based on the predicate device's testing.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary of the study conducted (as per the document):

The marketing clearance for the MedSource CathMED IV Catheter is based on a substantial equivalence determination to a legally marketed predicate device (MedSource IV Safety Catheter, K131555). The study essentially involved comparison and performance testing to demonstrate that the new device shares similar technological characteristics, indications for use, and performs equivalently to the predicate.

Key aspects of the "study" for this physical device include:

• Comparison Table: A detailed comparison of the new device and the predicate in terms of technology, indications for use, design (distal/proximal end configuration, catheter length/OD/needle gauge), sterilization method, and materials.
• Performance Testing: Declaration of compliance with various ISO standards related to intravascular catheters (ISO 10555-5, ISO 10555-1, ISO 594-1, ISO 594-2), as well as USP for particulate matter. These tests would involve physical and mechanical evaluations of the device's properties.
• Biocompatibility: A statement of conformance, indicating that because there were no material changes, the biocompatibility testing from the predicate device was leveraged. This implies the materials used in the new device are known to be biocompatible based on prior testing of the predicate.
• Sterility: Conformance to ISO 11135:2014 for ethylene oxide sterilization.

The conclusion states that "based on the indication for use, technological characteristics and performance testing, the differences between the MedSource CathMED IV Catheter and the predicate did not raise concern for safety and effectiveness." This indicates that the performed testing implicitly demonstrated that the device met the requirements of the standards, thus proving its substantial equivalence.

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