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The Riptide™ Aspiration Pump is intended as a vacuum source for Medtronic aspiration devices or systems for use in hospitals or clinics. Refer to the Instructions for Use included with the accessory aspiration device for indications related to the procedure for which this device will be used.

The Riptide™ Aspiration Pump is an externally powered electromechanical device capable of generating a vacuum designed for drawing fluids and thrombus into the Riptide™ Collection Canister during interventional procedures. It is intended for general suction use in hospitals or clinics and is not intended for transport or field applications. The Riptide™ Aspiration Pump includes a receptacle that holds the Riptide™ Collection Canister with Intermediate Tubing in place. The intermediate tubing is connected to the vacuum inlet port.

The Riptide™ Aspiration Pump package includes the following:

• Riptide™ Aspiration Pump (LMT-RAP)
• Region specific power cord for connection to earthed receptacle.
• Riptide™ Aspiration Pump User's Manual

The following item is required for use with Riptide™ Aspiration Pump (packaged separately):

• Riptide™ Collection Canister with Intermediate Tubing (LMT-RCT)

The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single use. The Riptide™ Collection Canister is the repository for aspirated material. The Riptide™ Canister is placed into the receptacle of the Riptide™ Aspiration Pump as shown in Figure 3. The Intermediate Tubing is then connected to the vacuum inlet port.

Here's an analysis of the Riptide™ Aspiration Pump's acceptance criteria and the study proving it, based on the provided document:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical trial data. Therefore, the device's acceptance criteria are framed in terms of meeting established standards and matching the performance of a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Riptide™ Aspiration Pump are primarily based on compliance with international standards for medical electrical equipment and medical suction equipment, as well as demonstrating equivalent performance to the predicate device.

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

The document indicates that the determination of substantial equivalence is based upon non-clinical bench testing. It does not specify a "test set" in the context of clinical data, as no clinical studies were performed.

• Sample Size for Test Set: Not applicable as no clinical test set was used. The performance evaluation was based on bench tests of the device itself.
• Data Provenance: The data provenance is from bench testing conducted by Micro Therapeutics Inc. d/b/a ev3 Neurovascular (the applicant). This is internal testing, not data from a specific country or clinical setting, and is prospective in nature (tests performed on the device to establish its performance).

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

Not applicable. For this type of 510(k) submission based on non-clinical bench testing, "ground truth" is not established by medical experts for a test set of patient cases. Instead, compliance with established engineering and medical device standards (e.g., IEC, ISO, FDA guidance) serves as the "ground truth" for technical performance.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction." Therefore, there is no effect size of human readers improving with or without AI assistance.

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

While the device is an electromechanical pump (not an AI algorithm), the performance data presented is standalone performance of the device itself, evaluated through bench testing without human-in-the-loop performance as part of its primary performance evaluation for this submission. The "User Manual Design Validation" does involve human factors, but this is about the usability of the manual, not the device's functional performance itself.

7. The Type of Ground Truth Used

The "ground truth" for this submission is:

• Compliance with recognized international standards: IEC 60601-1, IEC 60601-1-2, ISO 14971, ANSI/AAMI HE75, ISO 10079-1, and ISO 10079-4.
• Equivalence to a legally marketed predicate device: Penumbra Pump MAX™ (K122756) in terms of fundamental technological characteristics and performance attributes (vacuum range, flow rate, materials, operating life).
• Equivalence to a reference device: Riptide™ Aspiration System (K172448) for certain updated characteristics like duty cycle, volume, and shelf life of the collection canister, where these characteristics are deemed equivalent to or improve upon the predicate without raising new safety/effectiveness concerns.

There is no pathology, outcomes data, or expert consensus on patient cases used as ground truth for this mechanical device submission.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, an aspiration pump, not a machine learning or AI algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this device.

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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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