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TherOx Infusion Guidewires are intended for use in facilitating the placement of interventional devices in the cardiovascular and neurovascular system. TherOx Infusion Guidewires are designed for small vessel use.

TherOx Infusion Guidewires are also intended to be used for the controlled selective infusion of physician-specified fluid agents before, during or after interventional procedures in the cardiovascular or neurovascular system.

TherOx Infusion Guidewires are not intended for delivery of contrast agents. Fluid agents utilized with TherOx Infusion Guidewires should be fully prepared and used according to their manufacturer's instructions for use.

TherOx Infusion Guidewires are intended for use in facilitating the placement of interventional devices in the cardiovascular and neurovascular system. TherOx Infusion Guidewires are designed for small vessel use.

TherOx Infusion Guidewires are also intended to be used for the controlled selective infusion of physician-specified fluid agents before, during or after interventional procedures in the cardiovascular or neurovascular system.

TherOx Infusion Guidewires are not intended for delivery of contrast agents. Filuid agents utilized with TherOx Infusion Guidewires should be fully prepared and used according to their manufacturer's instructions for use.

TherOx Infusion Guidewires are not intended for neonatal or pediatric use.

The TherOx Infusion Guidewire has an outside diameter of .014 in. and is available 180 cm and 300 cm in length, and is intended to pass freely thru standard catheters that have a thru lumen of 016 in. or larger.

The 300 cm TherOx Exchange Guidewire differs only in its overall length from the 180 cm TherOx Infusion Guidewire. The distal 180 cm of the TherOx Exchange Guidewire is identical to the 180 cm TherOx Infusion Guidewire. Only the proximal hypotube has been extended by 120 cm to achieve the 300 cm length. This extended proximal portion always remains outside the body and facilitates the replacement of one interventional device for another.

A proximal fluid connection is secured by connecting the proximal open end to a simple Tuohy-Borst connection. The infusion guidewire may be torqued by rotation of the torquing knob to direct the orientation of the distal tip.

Here's a breakdown of the acceptance criteria and the study information for the TherOx Infusion Guidewires, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and concludes that the device meets its functional specifications and is safe for its intended use, or performed comparably to predicate devices.

However, we can infer the acceptance criteria from the "Summary of Studies" section and present the reported performance against these implicit criteria:

Study Details

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

   • In Vitro Tests: "Sample 2X sterilized (EtO) product" was used. This implies at least two samples for each test, but a specific number is not given for all tests. The data provenance is testing conducted in a laboratory setting ("bench testing").
   • In Vivo Tests: 3 closed-chest dogs and 2 closed-chest pigs were used. This is prospective animal data.
   • Clinical Study: No specific sample size is provided for the clinical study. The provenance is implied to be human clinical data, but details are absent.

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

   • In Vitro Tests: No "experts" were explicitly mentioned for ground truth. Testing was based on "functional specification" and "design specifications."
   • In Vivo Tests: "Investigators" concluded findings, but their number and specific qualifications (e.g., DVM, cardiologist) are not provided. They evaluated performance based on fluoroscopic visualization and observation of trauma.
   • Clinical Study: No details are provided regarding experts, ground truth establishment, or qualifications.

3. Adjudication method for the test set:

   • Not applicable as the reported studies primarily involved direct measurements, observations, and comparisons rather than expert consensus on a test set in the diagnostic AI sense.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a guidewire, not an AI-powered diagnostic tool, so this type of study is not relevant. The comparisons were between the TherOx guidewire and commercially available guidewires (predicate devices).

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

   • Not applicable. This is a medical device (guidewire), not an algorithm or AI system. Its performance is inherent to its physical properties and function.

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

   • In Vitro Tests: Design specifications, functional specifications, and industry guidelines (FDA's PTCA Catheter System Testing Guideline, Tripartite Agreement on Biocompatibility, ISO 10993-1).
   • In Vivo Tests: Direct observation of device performance, maneuverability, radiopacity, compatibility, and lack of adverse events (vascular trauma) by "investigators," likely using objective metrics and fluoroscopic visualization. Comparison against performance of commercially available guidewires served as a comparative ground truth.
   • Clinical Study: The "comparable performance as an accessory device" implies clinical observations and potentially outcomes, but specific details on what "comparable" means or how it was measured are not provided.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model, so there is no "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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