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The Clari Vein IC is indicated for infusion of physician specified agents in the peripheral vasculature.

The ClariVein IC is a specialty infusion catheter with 360°rotatable fluid dispersion wire connected to a proximally located integral battery powered motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features which facilitate physician-controlled infusion of the selected agent. The ClariVein IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The Clari Vein IC has no user serviceable parts or capital equipment. It is provided to the user sterile, for single patient use and is fully disposable.

The provided document is a 510(k) Premarket Notification for the ClariVein IC device. This type of FDA submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials.

The document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device, which would typically involve performance metrics like sensitivity, specificity, AUC, etc., on a clinical dataset. Instead, it describes non-clinical testing to demonstrate that the device functions as intended and is safe for its indicated use, relying heavily on its similarity to a predicate device.

Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria, AI/ML performance, sample size, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information provided for this specific device's 510(k) submission.

The document explicitly states:
"H. Clinical Testing: Not applicable."
"I. Animal Testing: Not applicable."

This signifies that the FDA's substantial equivalence determination for this device did not require human or animal clinical studies to demonstrate its performance against specific clinical acceptance criteria in the way you've outlined for an AI/ML device.

The "Performance Data" section (G) focuses on:

• Compliance with Industry Standards: (ISO, ISTA, IEC) related to the physical characteristics, safety, and manufacturing processes of medical devices.
• Biocompatibility Testing: To ensure the materials used in the device are safe for contact with human tissue.
• Nonclinical Performance Testing: Mechanical and functional tests (e.g., tensile strength, leak tests, wire rotation speed, torque force, simulated use) to verify the device's physical integrity and functional parameters.

Summary of Device Performance (based on provided text, not an AI/ML context):

Reasons why the other requested information cannot be provided from this document:

• Sample sized used for the test set and data provenance: No clinical test set. The non-clinical tests typically involve a sample of devices tested under laboratory conditions, but specific sample sizes for these engineering tests are not detailed here. Data provenance (country, retrospective/prospective) is not relevant for non-clinical lab tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set requiring expert ground truth for diagnostic or prognostic performance.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (no clinical test set).
• 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 (not an AI/ML device; no MRMC study).
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI/ML device).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (no clinical ground truth established for performance metrics). The "ground truth" for the non-clinical tests would be the pre-defined engineering specifications and standards.
• The sample size for the training set: Not applicable (not an AI/ML device).
• How the ground truth for the training set was established: Not applicable (not an AI/ML device).

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The ClariVein™ Infusion Catheter is intended for the infusion of physician-specified agents in the peripheral vasculature.

The ClariVein™ Infusion Catheter (ClariVein™-IC) is an infusion catheter system designed to introduce physician-specified medicaments into the peripheral vasculature. Infusion is through an opening at the distal end of the catheter and fluid delivery is enhanced by the use of a rotating dispersion wire to mix and disperse the infused fluid in the blood stream and on the vessel wall. The dispersion wire, connected to an interface cartridge for proximal connection to the motorized handle, extends through the catheter lumen. Prior to drug infusion the catheter sheath is inserted into the vasculature and once the catheter tip is positioned at the treatment site, the catheter sheath is retracted to expose the dispersion wire tip. Wire rotation is controlled by a 9V DC motorized Handle Unit. The Handle Unit also provides a grip and syringe holder to facilitate physiciancontrolled infusion.

The provided text describes the ClariVein™ Infusion Catheter and its non-clinical performance testing. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested about sample sizes, ground truth establishment, or multi-reader studies.

The document focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety standards for infusion catheters.

Here's an attempt to extract the requested information based on the provided text, combined with an explanation of what is not present:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, it refers to industry standards and general performance adequacy.

Missing Information: Specific quantitative thresholds for "adequate performance" for each test are not provided. For example, what is the maximum acceptable fatigue, minimum tensile strength, or specific system performance metrics?

Study Information (Based on provided text)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified. The document mentions "additional testing" without giving specific units or quantities for the tests (e.g., number of catheters tested for fatigue).
   • Data Provenance: Not specified. The testing is non-clinical, likely conducted by the manufacturer, but the location or whether it was prospective/retrospective is not mentioned.

2. 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):

   • This is not applicable as the "testing" described is non-clinical (mechanical and safety testing of the device itself) rather than clinical performance based on expert interpretation of medical data. There is no mention of human experts establishing ground truth for these non-clinical tests.

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

   • Not applicable. This refers to adjudication in studies where human readers are interpreting medical data, which is not the type of study described here.

4. 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. This is a non-clinical 510(k) submission for an infusion catheter, not an AI or imaging device requiring MRMC studies.

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

   • Not applicable. This device is not an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For the non-clinical tests, the "ground truth" would be established by engineering specifications, material standards, and validated testing methodologies (e.g., fatigue cycles, force applied for tensile strength, simulated physiological conditions for system performance). There is no "expert consensus" in the medical sense or pathology data involved in these types of non-clinical tests.

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning model that requires a training set.

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

   • Not applicable, as there is no training set for this device.

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