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The EndoWave® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature,

This FDA 510(k) summary for the EndoWave Infusion System (K071933) indicates that the submission is for an administrative correction to an already cleared device, primarily for a product code update (page 0). The original substantial equivalence (SE) determination was made in 2007 (page 1). Because this is an administrative update, the provided information does not describe a new study conducted to establish acceptance criteria for the device's performance in the context of an AI/ML algorithm.

The document discusses the EndoWave Infusion System which is a medical device for controlled and selective infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature (page 3, 4). The "device" in the context of the question refers to this physical system, not an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance related to AI/ML algorithm.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance information.
• Type of ground truth used for AI/ML.
• Sample size for the training set for AI/ML.
• How ground truth for the training set was established for AI/ML.

The document briefly mentions a "Test Summary" on page 5, which states: "The proposed EndoWave Infusion System is considered to be substantially equivalent to the currently marketed EndoWave Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed." However, it does not provide details about the specific tests, acceptance criteria, or their results. It instead points to "Substantial Equivalence" as the basis, comparing it to a previously cleared device (K060422). This implies that performance was assessed against the predicate device rather than through a new, full-blown clinical study with specific acceptance criteria that would typically be described for a novel device or AI/ML product.

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