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The Triever20 Curve is used coaxially within the Triever24 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 Triever20 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The Triever20 Curve Catheter is not indicated for use with FlowTriever Catheters.

The Triever20 Curve is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism.

The Triever20 Curve Catheter is inserted through the Triever24 Catheter 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 Triever Catheters are removed from the patient.

The provided text describes a 510(k) premarket notification for the Triever20 Curve Catheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an algorithm or artificial intelligence (AI).

Therefore, I cannot provide information on acceptance criteria and a study proving a device meets those criteria in the context of AI performance. The information requested regarding AI performance (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set) is not present in the provided document.

Instead, the document details non-clinical testing performed to demonstrate that modifications to the Triever20 Curve Catheter did not change its intended use or fundamental scientific technology, thereby demonstrating substantial equivalence to the predicate device (Inari FlowTriever Retrieval/Aspiration System, K191710).

Here's the relevant information about the acceptance criteria and the study performed, based only on the provided text, but explicitly noting its non-AI context:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list the quantitative acceptance criteria for each test or the specific numerical performance results. It lists the types of tests performed.

Specific tests conducted (implying the acceptance criteria for each were met):

• Package Integrity Inspection
• Visual & Dimensional Inspection
• Guidewire and Dilator Compatibility Verification
• Triever20 Curve Dilator Insertion and Removal
• Triever20 Curve Insertion into Triever24 and Retraction
• Triever20 Curve Rotation inside Triever24
• Triever20 Curve recovery angle
• Kink Radius
• Torque Test 1
• Torque Test 2
• Resistance to collapse under vacuum
• Determination of Flowrate Through Catheters & Dilator Burst Testing – Triever20 Curve Catheter
• Clot Burden Removal Validation
• Simulated Use and Tensile Testing - Torque
• Simulated Use and Tensile Testing - Tensile
• Simulated Use and Tensile Testing – Triever20 Curve Dilator
• Particulate Matter Determination

Tests leveraged from K173672 (implying acceptance criteria for these were also met):

• Pouch Seal Visual Inspection and Dye Penetration
• Pouch, Peel, Seal Strength
• Test Conical Fittings with 6% Luer taper
• Corrosion Resistance
• No air bubbles from fluid drawback
• Hemostasis
• Priming of the system
• Snap fit
• Sufficient vacuum
• Pyrogenicity
• Device Insertion
• Luer Lock Connection
• Dilator: Hub to Shaft attachment; Proximal shaft to Distal shaft attachment; Tip to Shaft attachment
• Hub and Catheter Leakage
• Dilator Burst

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

• Sample size: Not explicitly stated for each test. The document mentions "verification and validation testing" and "test results" in general but does not provide specific numbers of devices or tests conducted for each category.
• Data provenance: N/A, as this refers to non-clinical, in-vitro/benchtop testing of a physical medical device, not data for an AI algorithm.

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

• Not applicable. This was non-clinical engineering and performance testing of a physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.

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

• Not applicable. This refers to adjudication of expert opinions for AI ground truth, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This type of study is specifically for evaluating the effectiveness of AI with human readers, which is not the subject of this document.

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

• No, a standalone algorithm performance study was not done. The device is a physical medical catheter, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on established engineering and material specifications, regulatory standards, and the physical performance observed during the benchtop and in-vitro tests (e.g., flow rate measurements, tensile strength, burst pressure, clot removal efficacy in a simulated environment). It is not pathology, outcomes data, or expert consensus in an AI context.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI algorithm that would require a training set.

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

• Not applicable. No training set was used for an AI algorithm.

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