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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™ Aspiration System React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The Riptide™ Aspiration System React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath.

The proximal end of the Riptide™ Aspiration System React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The Riptide™ Aspiration System React™ 68 Catheter is designed with a hydrophilic coating. The Riptide™ Aspiration System React™ 68 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.

The document describes the acceptance criteria and supporting studies for the Riptide Aspiration System (React 68 Catheter). However, it's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria for a new AI/software device. The device in question is a medical device (catheter) for stroke revascularization, not an AI/software device that typically has performance metrics like sensitivity, specificity, or F1-score.

The acceptance criteria provided in the document are primarily for bench testing and biocompatibility, and the reported "performance" is whether the device "met the acceptance criteria" or specific qualitative observations, rather than a quantitative measurement against a numerical threshold.

Here's the information extracted from the provided text, structured to best fit your request, with an understanding that the device is a physical catheter and not an AI/software product in the context of typical AI acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

For the Riptide Aspiration System (React 68 Catheter), acceptance criteria are primarily related to bench testing, biocompatibility, and animal testing. The reported "performance" is whether the device met these criteria.

2. Sample Sizes and Data Provenance (Not applicable for AI/software test set, but for testing performed)

• Biocompatibility and Bench Testing: The sample sizes are not explicitly stated for individual tests but are implied to be sufficient for standard regulatory testing (e.g., "The test article extract showed no evidence...", "Not a single animal showed..."). These are laboratory tests on physical devices/extracts.
• Animal Testing: Conducted in a porcine model. Data provenance is from non-clinical laboratory studies performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP). This is prospective animal testing.

3. Number of Experts and Qualifications (Not applicable to this type of device submission for establishing ground truth)

This information is typically relevant for AI/software devices where human experts establish ground truth for image or data interpretation. For a physical catheter, ground truth is established through physical measurements, chemical analysis, and physiological responses as per standardized test methods. The document does not mention experts for ground truth establishment in this context.

4. Adjudication Method (Not applicable)

Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human labelers/experts when establishing ground truth for AI/software performance evaluation. Not relevant for this physical device submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not done/applicable)

MRMC studies are typically performed for AI/software devices to assess the impact of AI assistance on human reader performance. This device is a physical catheter, not an AI/software system, so such a study was not performed. The submission is based on demonstrating substantial equivalence to a predicate device through bench and animal testing.

6. Standalone Performance (Algorithm only without human-in-the-loop performance) (Not applicable)

This concept applies to AI/software algorithms. The Riptide Aspiration System is a physical catheter intended for use by a clinician. Its "performance" is inherently linked to its physical properties and interaction within a biological system, not a standalone algorithmic output.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established by:

• Standardized Test Methods and Criteria: For biocompatibility, microbial, and performance bench tests, "ground truth" is defined by adherence to specific ISO standards (e.g., ISO 10993, ISO 10555, ISO 11737), USP standards, and ANSI/AAMI standards. These standards define the acceptable range or qualitative outcome.
• Physiological Observations and Measurements: In animal studies, ground truth for safety, efficacy, and usability comes from direct observation of animal health, physiological responses, and procedural outcomes.

8. Sample Size for the Training Set (Not applicable)

This concept is for AI/machine learning models. The Riptide Aspiration System is a physical medical device. It does not have a "training set" in the context of AI. Design and manufacturing improvements would be based on engineering principles and iterative testing.

9. How the Ground Truth for the Training Set was Established (Not applicable)

Again, this is an AI/ML concept. The "ground truth" for the development of catheter designs comes from engineering specifications, material science, and prior knowledge of predicate devices and clinical needs, rather than a labeled training set.

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The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The React™ 68 Catheter is designed with a hydrophilic coating.

This is a 510(k) premarket notification for the React™ 68 Catheter. The document focuses on demonstrating substantial equivalence to predicate devices through design comparisons and extensive bench testing. Animal and clinical studies were not deemed necessary for this submission.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes numerous functional, biocompatibility, and sterilization-related tests. The "Acceptance Criteria" for each test are implicitly that the device "met the acceptance criteria" or demonstrated results within acceptable limits for safe and effective use. The "Reported Device Performance" is the stated outcome of each test.

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

The document does not explicitly state the sample sizes for each specific test within the bench testing. However, such tests would typically involve a statistically relevant number of units to ensure reliability. The data provenance is from bench testing conducted by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The data is prospective as it was generated specifically for this submission. The country of origin of the data is not explicitly stated but can be inferred as the United States given the FDA submission and the company's address in Irvine, CA.

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

Not applicable. This device is a physical catheter, and its performance is evaluated through objective, standardized physical and chemical tests (e.g., ISO standards, USP, visual inspection, dimensional measurements). There is no "ground truth" derived from expert interpretation in the context of diagnostic performance testing of, for example, medical images.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for this type of device's performance is established through objective laboratory testing against predetermined specifications and international standards, not through adjudications of expert opinions.

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 physical medical device (catheter) and not an AI or imaging diagnostic device. Therefore, MRMC studies are irrelevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the React™ 68 Catheter's performance is defined by its compliance with:

• Industry Standards: Such as ISO 10993 (Biocompatibility), ISO 11737-1 (Bioburden), ANSI/AAMI ST72 (Bacterial Endotoxin), USP / (Bacterial Endotoxin/Particulate), ISO 10555-1 (Catheter testing), ISO 594-1/80369-7 (Luer standards).
• Predicate Device Performance: Demonstrating substantial equivalence to legally marketed predicate devices in terms of materials, dimensions, and functional characteristics.
• Engineering Specifications: Internal design requirements for dimensions, material properties, and functional performance (e.g., tip buckling, kink resistance, lubricity, tensile strength).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for this device.

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