(29 days)
The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries, using continuous aspiration. The Riptide™ Aspiration System is composed of the following components and illustrated in Figure 1:
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- React™ 68 Catheter (REACT-68), React™ 71 Catheter (REACT-71, REACT-71-115, REACT-71-125)
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- Riptide™ Large Bore Aspiration Tubing (MAT-110-110)
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- Riptide™ Aspiration Pump (MAP-1000)
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- Riptide™ Collection Canister with Intermediate Tubing (MAC-1200)
The provided text is a 510(k) Summary for the Riptide™ Aspiration System, which details the device's characteristics and its substantial equivalence to a predicate device. However, this document does not describe a study involving acceptance criteria for algorithmic performance, expert ground truth adjudication, or human reader effectiveness studies. Instead, it focuses on non-clinical bench testing to demonstrate compliance with safety and performance standards for a physical medical device (catheter system).
Therefore, most of the requested information regarding AI/algorithm performance and clinical study details cannot be extracted from this document because it does not pertain to such a device or study.
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document lists various bench tests with pass/fail results. While these are performance metrics related to safety and functionality, they are for a physical medical device, not an AI algorithm.
| Test | Test Method Summary | Reported Device Performance (Results) | Acceptance Criteria (Implicitly "Pass") |
|---|---|---|---|
| Riptide™ Aspiration Pump | |||
| Electrical Safety (IEC 60601-1) | Electrical safety testing conducted per IEC 60601-1 Edition 3.2 2020-08. | Pass | Compliance with IEC 60601-1 |
| Electromagnetic Compatibility (IEC 60601-1-2) | Electromagnetic compatibility (EMC) testing conducted per IEC 60601-1-2 Edition 4.1 2020-09. | Pass | Compliance with IEC 60601-1-2 |
| Riptide™ Aspiration Pump and Riptide™ Collection Canister with Intermediate Tubing | |||
| Medical Suction Equipment (ISO 10079-1/10079-4) | Medical suction equipment testing conducted per ISO 10079-1 Fourth Edition 2022-03 and ISO 10079-4 First Edition 2021-08. | Pass | Compliance with ISO 10079-1 and 10079-4 |
| React™ 71 Catheter | |||
| Design Validation (Compatibility with minimum length 136 cm guide catheter) | The subject device was evaluated per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff" (February 2016) and per FDA recognized consensus standards ISO 14971 (Third Edition 2019-12) and IEC 62366-1 (Edition 1.1 2020-06 CONSOLIDATED VERSION). | Pass | Compatibility with guide catheter |
| Design Validation (Ability to navigate to the distal M1 segment of the MCA over a microcatheter) | The subject device was evaluated per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff" (February 2016) and per FDA recognized consensus standards ISO 14971 (Third Edition 2019-12) and IEC 62366-1 (Edition 1.1 2020-06 CONSOLIDATED VERSION). | Pass | Navigability to distal M1 segment |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes bench testing of a physical device, not a performance study on a software algorithm with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth as typically defined for AI/software evaluations is not mentioned. The "design validation" tests refer to compliance with guidance and standards, not expert clinical interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set of data is described.
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 not a study assessing AI assistance or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The document refers to "non-clinical bench testing" and compliance with international standards (IEC, ISO) and FDA guidance for the safety and performance of the physical device components.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth establishment relevant to an algorithm.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).