Search Results

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Riptide™ Large Bore Aspiration Tubing is provided sterile and intended for single-use. The Riptide™ Large Bore Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the catheter. The Riptide™ Large Bore Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Large Bore Aspiration Tubing is connected to the Riptide™ Canister (outside of the sterile environment) while the distal end of the Riptide™ Large Bore Aspiration Tubing is connected to the catheter (inside the sterile environment). The Riptide™ Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing. The Riptide™ Large Bore Aspiration Tubing is designed to allow the user to control the application via an in-line flow switch.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for the FDA. These summaries typically focus on demonstrating substantial equivalence to a predicate device, often by leveraging data from the predicate or conducting limited bench testing. They are not necessarily full-fledged clinical trials for a new device's efficacy. This document describes a component of a system (Large Bore Aspiration Tubing) and mostly relies on prior testing of the overall system and predicate device. Therefore, many of the typical AI/medical device study questions (like effect size, reader improvements, ground truth establishment for a training set) aren't directly applicable or answered in this context.

1. A table of acceptance criteria and the reported device performance

The document lists several tests, and for most, the acceptance criterion is implied by the "met the acceptance criteria" statement. Specific numerical criteria are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for specific tests. The tests mentioned are primarily bench tests on the device itself or leveraged from a predicate device. So, it refers to the number of units tested.
• Data Provenance: The tests are non-clinical bench tests. It doesn't involve human patient data or geographic origin in the way clinical studies do. The data is generated in a lab setting. It is essentially prospective in the sense that these tests were performed specifically for this submission.

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

Not applicable. This is not an AI/diagnostic device that establishes a "ground truth" based on expert interpretation. The tests are engineering and performance evaluations.

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

Not applicable. This is not an AI/diagnostic device requiring expert adjudication of results.

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 is a medical device (aspiration tubing), not an AI diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a medical device, not an algorithm.

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

The "ground truth" for the bench tests would be the established engineering/performance specifications and standards (e.g., ISO, ASTM, internal specifications) against which the device's performance is measured. For example, a leak test's "ground truth" is that there should be no detectable leak under specified pressure/vacuum.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model.

Ask a specific question about this device