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The Excipio LV Prime Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.

The Excipio LV Prime Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The device will be sold as a sterile, single use device.

The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (6-16 mm in diameter). The thickness of the basket wires enhances the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.

Let's break down the information regarding the acceptance criteria and study for the Excipio LV Prime Thrombectomy Device, based on the provided FDA 510(k) clearance letter.

It's important to note that this document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described here is primarily a non-clinical bench testing campaign aimed at proving the new device performs similarly and meets a defined set of engineering and performance specifications. There is no clinical study involving human (or animal) subjects described in this document for the Excipio LV Prime Thrombectomy Device. Thus, concepts like "human readers," "AI assistance," "effect size," or "ground truth for training/test set" in the context of clinical outcomes or diagnostic accuracy are not applicable to this type of device and submission.

Acceptance Criteria and Reported Device Performance

The document describes non-clinical laboratory testing performed to support the substantial equivalence. The acceptance criteria for these tests are implicitly that the device met the criteria and functioned as intended, with a performance profile similar to predicate devices. Specific quantitative acceptance criteria or detailed reported performance values are not explicitly stated in this summary. Instead, it broadly states that the device "met all acceptance criteria" and "functioned as intended."

Table of Acceptance Criteria and Reported Device Performance:

Study Details: Non-Clinical Bench Testing

Since this is a thrombectomy device and the submission is for 510(k) clearance based on substantial equivalence, the "study" referred to is a series of in vitro bench tests.

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not explicitly state the specific number of units tested for each non-clinical test (e.g., how many devices were subjected to kink resistance or tensile testing). This level of detail is typically found in the full 510(k) submission, not the summary.
   • Data Provenance: All data is from in vitro bench testing conducted by the manufacturer, Contego Medical, Inc. The country of origin for this testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contracted testing lab. This is by definition retrospective in the sense that the testing is performed before submission for clearance.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not Applicable. For non-clinical bench testing of a medical device, "ground truth" is established by engineering specifications, validated test methods, and industry standards (e.g., ISO standards). There are no "experts" establishing a clinical judgment ground truth in this context. The "experts" involved would be the design engineers, quality engineers, and test technicians who define the test protocols and interpret the results against the defined acceptance criteria.

3. Adjudication Method for the Test Set:

   • None Applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image interpretation studies where multiple human readers' opinions need to be reconciled to establish a ground truth. For bench testing, results are typically objective measurements compared directly against predetermined pass/fail criteria.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, not done. An MRMC study is relevant to diagnostic imaging devices or other technologies where human interpretation is involved. This device is a mechanical thrombectomy device; its performance is evaluated by its physical characteristics and efficacy in removing thrombus in a lab setting, not by aiding human readers in diagnosis.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

   • Not Applicable. This device is an invasive medical device, not a software algorithm. Its use inherently involves a human operator (a clinician) and is not "standalone" in the sense of an unassisted algorithm making decisions.

6. Type of Ground Truth Used:

   • For the non-clinical testing, the "ground truth" is defined by:
     • Engineering specifications and design requirements: For dimensional, kink resistance, torsional strength, tensile, radial force, and corrosion testing.
     • Validated test methods and industry standards (e.g., ISO 10993-1): For biocompatibility, simulated use, and clot removal testing.
     • Manufacturer's internal quality standards.

7. Sample Size for the Training Set:

   • Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a physical, mechanical medical device, not an AI/ML system.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. As above, there is no training set for this type of device.

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