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The Rist™ 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Rist™ Radial Access Selective Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.

The Rist™ Radial Access Selective Catheter is a flexible, single lumen catheter, with a radiopaque stainless-steel braid reinforced shaft to provide support. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes: Simmons 2 (SIM2) and Berenstein (BER). The braided, tapered shaft of the catheter is visible under fluoroscopy and has a luer connector in its proximal end for the attachment of accessories and the infusion of fluids. The Rist™ Radial Access Selective Catheter has no hydrophilic coating. The Rist™ Radial Access Selective Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The Rist™ 079 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The catheter has a radiopaque marker band on the distal end to aid in visualization. The distal 25 cm of the Rist™ 079 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The Rist™ 079 Radial Access Guide Catheter has a PTFE-lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 079 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The Rist™ 071 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The embedded stainless-steel flat wire cross coil is in the proximal section of the catheter, which transitions to a nitinol round wire single coil in the distal end. The catheter has a radiopaque platinum/iridium marker band on to aid in visualization. The distal 25 cm of the Rist™ 071 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The Rist™ 071 Radial Access Guide Catheter has a PTFE- lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 071 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

Despite the request for a detailed description of acceptance criteria and study information, the provided text does not contain information related to specific acceptance criteria, device performance metrics, or a study report in the context of AI/ML device evaluation.

The document is an FDA 510(k) Premarket Notification for a medical device (catheters), not an AI/ML diagnostic or prognostic system. Therefore, the questions about sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the content provided.

The document focuses on demonstrating substantial equivalence of the subject catheters to predicate devices, primarily based on design features, indications for use, and bench testing.

Here's a summary of what is available in the document, which addresses some points but not in the context of AI/ML performance evaluation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that:

• Acceptance Criteria (Implied): The acceptance criteria are implicitly defined by the standards outlined in ANSI/AAMI HE75:2009/(R) 2018. The document does not provide the specific numerical or qualitative acceptance criteria used within this standard for the "In-vitro Simulated Use Study."
• Reported Device Performance: The reported performance is a high-level statement: "The devices met the acceptance criteria." Specific metrics, ranges, or quantitative results are not provided.

2. Sample size used for the test set and the data provenance:
Not applicable, as this was a bench test and not an AI/ML study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment for medical images by experts is not relevant to this bench testing of physical catheter devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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 an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.

7. The type of ground truth used:
For the "In-vitro Simulated Use Study," the "ground truth" would be the successful completion of tasks or performance within acceptable parameters as defined by the ANSI/AAMI HE75:2009/(R) 2018 standard for simulated use. This is a technical performance standard, not a clinical ground truth.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

In summary, the provided text describes regulatory approval for physical medical devices (catheters) based on substantial equivalence and bench testing, not an AI/ML-driven device that would require the in-depth data and performance metrics requested in the prompt.

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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 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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