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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:

• 1. React™ 68 Catheter (REACT-68), React™ 71 Catheter (REACT-71, REACT-71-115, REACT-71-125)
• 2. Riptide™ Large Bore Aspiration Tubing (MAT-110-110)
• 3. Riptide™ Aspiration Pump (MAP-1000)
• 4. 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.

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.

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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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Riptide™ Aspiration System is composed of the following components:

1. React™ Catheters
2. Riptide™ Large Bore Aspiration Tubing
3. Riptide™ Aspiration Pump
4. RiptideTM Collection Canister with Intermediate Tubing
   No changes were made to the catheters, tubing or collection canister with intermediate tubing cleared in the predicate system under K172448 and, most recently, under K183185.
   The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide Aspiration System. The vacuum pressure of the Riptide Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The provided text describes the 510(k) clearance for the Riptide™ Aspiration System, a medical device, and its performance data. However, it does not describe a study that proves the device meets acceptance criteria related to an AI/ML component. The document details the device's technical specifications, non-clinical bench testing, and comparison to a predicate device, which are standard for K201689. It is a traditional medical device submission and does not involve AI/ML.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the provided text does not contain such a study or information.

If you have a document describing an AI/ML medical device and its validation study, please provide that, and I would be happy to analyze it according to your requested criteria.

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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™ 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.

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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 React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricious, polytetrafluoroethylene and Engage liner is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the split y-introducer sheath.

The proximal end of the React™ 71 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is designed with a hydrophilic coating. The React™ 71 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.

Based on the provided text, the Riptide™ Aspiration System (React™ 71 Catheter) is a medical device. The acceptance criteria and the studies performed are detailed in the "510(k) Summary: K182101."

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists numerous tests with their acceptance criteria (implicitly, as the results consistently state "met the acceptance criteria") and the reported device performance. Due to the extensive list, a summarized table is provided below, grouping similar types of tests.

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

The document does not explicitly state sample sizes for each bench or animal study. It mentions a "canine model" for the thrombogenicity test and a "porcine model" for the animal performance data. Specific numbers of animals or test articles used in these studies are not provided.

The data provenance is non-clinical bench and animal testing. There is no mention of human subject data. Therefore, it is entirely retrospective or prospective non-clinical data performed in a laboratory/animal setting. The country of origin of the data is not specified, but the submission is to the U.S. FDA, suggesting the studies were conducted to meet U.S. regulatory standards.

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

This information is not applicable as the studies are entirely non-clinical (bench and animal testing). The "ground truth" is based on the objective measurements and observations from the physical and biological tests conducted according to established standards (e.g., ISO, ASTM, USP).

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are entirely non-clinical. Adjudication typically refers to expert consensus or review in clinical studies.

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:

This information is not applicable. The device is a physical medical device (catheter), not an AI software. The studies described are non-clinical bench and animal tests, not an MRMC comparative effectiveness study involving human readers or AI assistance.

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

This information is not applicable. The device is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used:

The ground truth used for the non-clinical studies is based on:

• Objective Measurements: Such as dimensional measurements, pressure readings, flow rates, tensile strength, Luer standards, etc.
• Standardized Test Methods: Adherence to established international (ISO) and national (ASTM, USP, ANSI/AAMI) standards for evaluating materials, sterility, packaging, and performance.
• Biological Endpoints: In animal models, these include observations for systemic toxicity, sensitization, irritation, pyrogenicity, and direct measurement of thrombogenic potential.
• Visual Inspection and Functional Assessment: E.g., for coating integrity, recanalization, lumen patency, and usability by trained personnel.

8. The Sample Size for the Training Set:

This information is not applicable. This is a submission for a physical medical device. The concepts of "training set" and "testing set" are primarily relevant to machine learning and AI, which are not involved here. The non-clinical studies evaluate the device's inherent physical and biological properties.

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

This information is not applicable for the same reasons as #8.

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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.

Ask a specific question about this device

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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA 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. The Riptide™ Aspiration System is designed for use within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries. The Riptide™ Aspiration System is composed of the following components:

• Arc™ Catheter .
• Riptide™ Aspiration Tubing .
• Riptide™ Aspiration Pump ●
• Riptide™ Collection Canister with Intermediate Tubing .

The Arc™ Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. A lubricous, tapered liner is used to create a structure that has both proximal stiffness and distal flexibility. The Arc™ Catheter has a radiopaque marker band encapsulated at the distal tip for visualization under fluoroscopy. The Arc™ Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion. The Arc™ Catheter is the only component of the Riptide™ Aspiration System that is used intravascularly.

The Riptide™ Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the Arc™ Catheter. The Riptide™ Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Aspiration Tubing is connected to the Riptide™ Collection Canister (outside of the sterile environment) while the distal end of the Riptide™ Aspiration Tubing is connected to the Arc™ Catheter (inside the sterile environment). The Riptide™ Collection Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing.

The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide™ Aspiration System. The vacuum pressure of the Riptide™ Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide™ Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

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 and the repository for aspirated material. The Riptide™ Collection Canister is placed into the receptacle of the Riptide™ Aspiration Pump while the Intermediate Tubing is connected to the vacuum inlet port.

The provided text describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the Riptide™ Aspiration System to its predicate device, the Penumbra System® and Penumbra Pump MAX™.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists numerous tests conducted on various components of the Riptide™ Aspiration System, with an explicit statement that the device met the acceptance criteria for each. The specific acceptance criteria values are generally not quantified in the "Results" column, but rather stated qualitatively (e.g., "met the acceptance criteria").

Table 1: Acceptance Criteria and Reported Device Performance (Summary)

Study Information:

The provided document describes non-clinical bench testing and non-clinical animal testing. It explicitly states "Not Applicable" for clinical performance data. Therefore, questions related to human reader studies, ground truth establishment for a test set of clinical images, and training set details are not directly addressed in this document.

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

• Test Set Sample Size:
  • Bench Testing: The document does not specify the exact sample sizes (number of units tested) for each individual bench test. The nature of these tests often involves a batch of devices or components.
  • Animal Testing: The document mentions "a porcine model" but does not specify the number of animals used for the animal testing.
• Data Provenance:
  • Bench Testing: Conducted by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, as part of their R&D and regulatory submission process. Location not specified, but the company is based in Irvine, California, USA.
  • Animal Testing: Conducted "in a porcine model." Location not specified.
  • Retrospective/Prospective: These are non-clinical studies (bench and animal), so the terms retrospective/prospective in the context of human data acquisition do not directly apply. They are inherently prospective in the sense that the tests were designed and executed to evaluate this specific device for its regulatory submission.

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. The studies described are non-clinical (bench and animal). There is no mention of human expert-established ground truth for a test set of clinical images or data. The "ground truth" for these tests comes from objective measurements against defined standards (e.g., ISO, ASTM, USP standards, or internal specifications) and observations in animal models.

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

• Not Applicable. As no human expert evaluation of clinical data for ground truth establishment is described, adjudication methods are not relevant to this submission.

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

• No. The document explicitly states "Performance Data - Clinical: Not Applicable." This means no human reader studies (MRMC or otherwise) were conducted or submitted as part of this 510(k). The device is not an AI-powered system that assists human readers.

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

• No. This device is a medical instrument (aspiration system for stroke), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

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

• Bench Testing: Ground truth is established by objective measurements against pre-defined engineering specifications, international standards (ISO, ASTM, USP), and validated test methods. For example, "The Arc™ Catheter met the acceptance criteria for EO Residual" means the measured residual levels were below the established safe limits per ISO 10993-7.
• Animal Testing: Ground truth is established through direct observation and measurement in a controlled porcine model, in accordance with "21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies". The goal was to evaluate "safety, efficacy, and usability" and compare it to the predicate device.

8. The sample size for the training set

• Not Applicable. No AI/machine learning component is described for this device, so there is no concept of a "training set" in the context of algorithm development.

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

• Not Applicable. As there is no training set for an AI algorithm mentioned, this question is not relevant.

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