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The Laguna Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The Laguna Thrombectomy System is intended for use in the peripheral vasculature.

The Malibu Aspiration Catheter™ System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The Malibu Aspiration Catheter™ System is intended for use in the peripheral vasculature.

The Laguna Clot Retriever™ System is a single use, sterile, non-pyrogenic medical device designed for use in the peripheral vasculature. The Laguna Clot Retriever™ System is intended be used in conjunction with the Malibu Aspiration Catheter™ System. The combined use of the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System is referred to as the Laguna Thrombectomy System.

The Laguna Clot Retriever™ is used to engage and retrieve emboli and thrombi into the Malibu Aspiration Catheter™. The Laguna Clot Retriever™ is designed with a flexible pusher attached to a distal self-expanding, laser cut, closed cell design Nitinol structure. The self-expanding portion is delivered inside a delivery sheath. The flexible pusher is designed with stainless steel reinforcement and a polymer. The retriever head is designed with and without radiopaque body markers. The retriever head designed with radiopaque body markers is intended to visualize the expansion and collapse of the Laguna Clot Retriever™.

The Malibu Aspiration Catheter™ System is a single use, sterile, non-pyrogenic medical device designed for use in the peripheral vasculature. The Malibu Aspiration Catheter™ System is intended be used independently and in conjunction with the Laguna Clot Retriever™ System.

The Malibu Aspiration Catheter™ is intended for retrieving thrombi or emboli and/or infusing fluids into the peripheral vasculature. The Malibu Aspiration Catheter™ is designed with a single lumen and comprised of tubes for aspiration and infusion connected proximally to its hub. Two-way flow control valves are located at the end of aspiration and infusion tubes, respectively. The aspiration tube can be connected to a locking vacuum syringe via its two-way valve. Similarly, the infusion tube can be connected to a syringe to infuse fluids through the catheter. The Malibu Aspiration Catheter™ is designed with a radiopaque marker band at the distal tip for fluoroscopic visualization. In addition, the Malibu Aspiration Catheter™ is also available with a second marker band located proximally to the distal marker band. The Malibu Aspiration Catheter™ is supplied with a dilator and a 60cc locking syringe. The Malibu Aspiration Catheter™ incorporates a metallic reinforcement made of stainless steel, an inner liner made of polytetrafluoroethylene, and polymeric jacket material having gradient softness. The distal segment of the Malibu Aspiration Catheter™ is coated with a hydrophilic coating to optimize lubricity and reduce friction.

The provided document is a 510(k) premarket notification for the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System (Laguna Thrombectomy System). It details the device's indications for use, device description, comparison to a predicate device, and performance data from bench and animal studies to support substantial equivalence.

However, the document does not contain information about clinical studies with human subjects, acceptance criteria in the context of clinical performance, sample sizes for test sets in human studies, data provenance, expert adjudication for ground truth, MRMC studies, standalone algorithm performance, or details on training sets. The document explicitly states: "A determination of substantial equivalence is based upon successful completion of performance data – bench and animal." This means clinical performance data from human studies or AI performance metrics are not part of this submission for substantial equivalence.

Therefore, many of the requested details, particularly those related to human clinical performance and AI algorithm validation, cannot be extracted from this document.

Here's what can be gathered from the provided text:

Reported Device Performance (from bench and animal studies):

The document lists various performance evaluations conducted for the device. These are primarily related to physical and mechanical characteristics and initial safety in an animal model.

Information Not Available in the Document:

Given that the determination of substantial equivalence was based solely on bench and animal performance data, the following questions cannot be answered from the provided text:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No human clinical test set data is mentioned. The animal study was done in a porcine model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no human clinical test set or AI performance data requiring expert ground truth is presented.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 a medical device (catheter/retriever system), not an AI diagnostic algorithm, and no human clinical effectiveness study is described.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the animal study, the ground truth would be based on ex-vivo analysis of the animal tissue/vessels and potentially imaging, but not "expert consensus" in the diagnostic sense or pathology for human disease.
• The sample size for the training set: Not applicable, as this is hardware, not an AI algorithm.
• How the ground truth for the training set was established: Not applicable.

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