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The Provena™ Midline Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use with power injectors.

Provena™ Midline Catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with accessories for reliable short term (less than 30 days) vascular access. The Provena™ Midline Catheters are suitable for use with power-injectors.

The provided FDA 510(k) summary for the Provena™ Midline Catheter does not describe a study involving an AI/Machine Learning device or an analysis of clinical images. Instead, it details a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device through material, dimensional, and performance characteristic comparisons.

Therefore, many of the requested details regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment) are not applicable to the content provided.

However, I can extract and present the device performance characteristics and the type of testing performed to demonstrate substantial equivalence, which serves as a form of "acceptance criteria" for a non-AI/ML device in this context.

Here's a breakdown based on the provided document, addressing the applicable points:

Device: Provena™ Midline Catheter (Non-AI/ML Device)

1. A Table of Acceptance Criteria and the Reported Device Performance (as demonstrated by testing against the predicate):

This table compares the characteristics of the subject device (Provena™ Midline Catheter) to the predicate device (PowerMidline™ Catheter) to demonstrate substantial equivalence, rather than defining specific statistical performance metrics against a clinical ground truth as would be done for an AI/ML device. The "reported device performance" is the equivalency shown through these characteristics and the results of specified performance tests.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable in the context of clinical data for AI/ML. The "test set" here refers to the physical devices for engineering performance testing. Numbers of units tested for each engineering test (e.g., burst pressure, tensile strength) are not specified in this summary but would be part of the underlying design verification documentation.
• Data Provenance: The 'data' for this submission is primarily engineering test results on newly manufactured devices. There is no mention of patient data (e.g., country of origin, retrospective/prospective).

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

• Not applicable as this is not an AI/ML device requiring clinical image interpretation or ground truth establishment by experts. The "ground truth" for this device's performance is established by engineering specifications and industry standards.

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

• Not applicable as there is no human interpretation of data requiring adjudication for this device type.

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, an MRMC study was not done 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):

• The "ground truth" for this device's substantial equivalence is based on:
  • Engineering Specifications: Defined physical and performance characteristics.
  • Industry Standards: Compliance with standards like ISO 10555-1 (Sterile, single-use intravascular catheters) and USP 788 (Particulate Matter Testing).
  • Risk Analysis: Performed in accordance with BS EN ISO 14971 (Risk Management for Medical Devices).

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device that requires a training set.

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

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

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