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The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

The Reverse Medical ReCruit™ Microcatheter consists of a flexible, tapered reinforced composite catheter with a braided mesh retrieval element attached to the distal region of the catheter. The inner lumen can accommodate a guidewire to aid in placement of the catheter. The catheter contains radiopaque markers to facilitate fluoroscopic visualization- a distal tip marker, markers at the proximal and distal end of the retrieval element, and circumferentially placed markers within the retrieval element. The retrieval element is deployed through the advancement of a guidewire or the ReAct™ stylet through the lumen to radially expand the retrieval element. The selection of guidewire sizes in accordance with device compatibility allows for guidewires to be used either for navigation and placement or for deployment of the element. The proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is coated with a hydrophilic coating. The catheter is designed to be used with a guide catheter. The catheter is offered in various retrieval element sizes to accommodate physician preferences and patient anatomy. Each ReCruit™ Microcatheter is packaged with a ReAct™ stylet and torque device. The ReAct™ stylet is a stainless steel wire with a platinum tip that may be used to activate the ReCruit™ Microcatheter's retrieval element. The ReCruit™ Microcatheter can be used in vessel diameters ranging from 2mm to 4mm. Materials used in the Reverse Medical ReCruit™ Foreign Body Retrieval Microcatheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.

The provided text does not contain specific acceptance criteria or an analytical study proving the device meets those criteria. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

However, based on the information provided, we can infer some aspects related to how performance was demonstrated:

Acceptance Criteria and Reported Device Performance (Inferred):

Since this is a 510(k) submission for substantial equivalence, the "study" demonstrating the device meets criteria is primarily focused on demonstrating that its performance characteristics are comparable to a legally marketed predicate device, rather than establishing entirely new performance benchmarks. The preclinical studies mentioned would support this claim of comparable performance.

Here's a breakdown of the other requested information based on the provided text:

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

   • Sample size for test set: Not explicitly stated. The text mentions "in vitro and in vivo laboratory studies" but does not quantify the number of tests, simulated retrievals, or animals/models used.
   • Data provenance: "in vitro and in vivo laboratory studies." This suggests the studies were conducted in a controlled lab setting, likely by the manufacturer or a contract research organization. The country of origin is not specified but is implied to be related to the submitting company (Reverse Medical Corporation, likely US-based, given FDA submission). The studies would be considered prospective as they were conducted to test the device's performance.

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

   • Not applicable/Not provided. For a device like a microcatheter, "ground truth" would likely be established by direct observation of successful retrieval, measurement of forces, or biological responses in established models, rather than expert consensus on diagnostic images. The performance would be assessed against engineering specifications or successful outcomes as defined by the study protocol.

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

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., image reading). For direct device performance studies, success or failure is usually determined by objective criteria defined in the study protocol.

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 MRMC study was done. This type of study relates to diagnostic AI devices involving human readers, which is not applicable to a foreign body retrieval microcatheter.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm. Its performance inherently involves human manipulation (human-in-the-loop).

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

   • For the "in vitro" studies, the ground truth would be based on objective physical measurements and observations (e.g., successful capture and removal of foreign objects, force measurements, catheter trackability, deployment efficacy) against predefined engineering specifications.
   • For the "in vivo" studies, the ground truth would be based on direct observation of physiological response and device function in a living system (e.g., successful retrieval, absence of vessel damage, adherence to anatomical constraints) against specified animal model outcomes.
   • For biocompatibility, the ground truth is established by conformance to ISO 10993-1 and FDA requirements through specific biological tests.

7. The sample size for the training set:

   • Not applicable/Not provided. This device is not an AI algorithm that requires a "training set."

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

   • Not applicable. As noted above, there is no "training set" for this physical device.

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