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The Triever16 Curve 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 Triever16 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever16 Curve is not indicated for use with FlowTriever Catheters.
The Triever16 Curve is also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

The Triever16 (“T16”) Curve is a single-use, over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature, the treatment of pulmonary embolism, and the treatment of clot in transit in the right atrium.

The T16 Curve is inserted over a pre-placed 0.035" guidewire, either standalone (i.e., through an introducer sheath without another catheter) or through a compatible Inari device such as the Triever20/24, Intri24 Sheath, 16 Fr ClotTriever Sheath, or Protrieve Sheath (packaged separately), and advanced to the thrombus. Thrombus is removed by aspiration with the provided 60 cc Large Bore Vacuum syringe. After the procedure is complete, the T16 Curve is removed from the patient.

The provided text is a 510(k) summary for the Inari Medical Triever16 Curve, an embolectomy catheter. The document states that "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This means there is no data presented regarding the device's performance in a clinical setting against acceptance criteria established for clinical effectiveness.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to non-clinical bench testing to demonstrate the device's physical and functional properties, and its substantial equivalence to a predicate device.

Therefore, the following information is based on the non-clinical bench testing described in the document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not provide specific numerical acceptance criteria or the exact reported performance values for each test. Instead, it lists the types of tests performed.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices) used for each non-clinical bench test.
• Data Provenance: The data is from non-clinical bench testing conducted to support the 510(k) submission. The country of origin is not explicitly stated, but as the submitting entity (Inari Medical, Inc.) is located in Irvine, California, USA, it is highly probable the testing was conducted in the USA or by facilities approved by US regulatory standards. The testing is inherently prospective in nature, as it was performed specifically to evaluate the new device against predetermined specifications.

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

This question is not applicable in the context of this document. For non-clinical bench testing of a medical device, "ground truth" is typically established by engineering specifications, material standards, and validated test methods, not by expert consensus on clinical data. The tests are designed to objectively measure physical and functional properties, and the "experts" involved would be qualified engineers, technicians, and quality control personnel.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus on clinical image interpretation or outcomes, not for objective bench testing. The results of bench tests are typically measured quantitatively and compared against pre-defined numerical or qualitative acceptance criteria.

5. 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. This document pertains to the clearance of a mechanical medical device (embolectomy catheter), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed as described. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence."

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

Not applicable. As noted above, this device is a mechanical catheter and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical bench tests was based on:

• Engineering Specifications: Predefined design parameters, material properties, and performance requirements.
• International Standards: e.g., ISO 10993-1 for biocompatibility, ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016 for sterilization.
• Validated Test Methods: Procedures established to reliably measure the device's characteristics.
• Predicate Device Characteristics: Comparison against the known characteristics and performance of the legally marketed predicate device (Inari FlowTriever Retrieval/Aspiration System K213402) and reference devices (Penumbra Indigo System Aspiration Catheter 12 K192981) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As this device is not an AI/ML model, there is no training set or associated ground truth establishment process in that context.

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