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The Spartan SC 069TM is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Spartan SC 069™ is a support catheter designed for the introduction of interventional devices into the peripheral and neuro vasculature. The SC 069™ is a single lumen, flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the device is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating to reduce the overall frictional force during intravascular use. The device is supplied sterile and intended for single use only.

The provided text describes the performance data for the Spartan SC 069™ support catheter. This device appears to be a medical device, and the information presented is from a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's diagnostic performance. Therefore, many of the requested fields regarding diagnostic acceptance criteria, multi-reader multi-case studies, and human-in-the-loop performance are not applicable.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical bench tests and biocompatibility tests, with each test summary implying a pass/fail acceptance criterion. The results consistently state that the Spartan SC 069™ "met the acceptance criteria" or showed "acceptable" performance, or similar to the predicate 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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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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The Reverse™M Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

The Reverse™ Micro Catheter is a single lumen catheter designed to be introduced over a steerable guide wire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate vessel navigation. The micro catheter incorporates a PTFE liner to facilitate movement or introduction of devices passed through its lumen. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability. The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID.

The document you provided describes a medical device, the Reverse™ Micro Catheter, and its non-clinical performance evaluation for substantial equivalence to a predicate device. It does not describe a study involving an AI model or a specific algorithm. Therefore, I cannot provide information about acceptance criteria, device performance, sample sizes, ground truth, expert involvement, or comparative effectiveness studies in the context of AI.

The document focuses on demonstrating that the modified Reverse™ Micro Catheter is substantially equivalent to a previously cleared device (Reverse™ Medical Microcatheter, K130858) based on non-clinical performance data.

Here's a breakdown of what the document does provide, structured to address the spirit of your request where possible, but re-contextualized for a medical device rather than an AI study:

1. A table of acceptance criteria and the reported device performance

The document states that "All testing passed the acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. The performance results are reported as successful completion of tests without new safety or effectiveness issues.

• Dimensional requirements
• Lubricity/friction
• Particulates
• Coating characterization
• Simulated use device compatibility
• Simulated use navigation and delivery
• Shelf-life verification (1 year accelerated aging) | "All testing passed the acceptance criteria."
  "Comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness." | Implicitly, meeting specifications and predicate equivalence. |
  | Biological Safety | - MEM Elution Cytotoxicity
• Guinea Pig Maximization Sensitization
• Intracutaneous Reactivity
• Acute System Injection
• Materials Mediated Rabbit Pyrogen
• Hemolysis Direct Contact
• Hemolysis Indirect Extract Method
• Complement Activation
• In vivo Thrombogenicity
• Genotoxicity (Ames Assay, in vitro Mouse Lymphoma, in vivo Mouse Micronucleus)
• USP Physicochemical | "Testing demonstrated that the Reverse™ Micro Catheter finished device, accessories, and packaging materials have no residual risk of biological hazards; and are therefore considered biocompatible for their intended use." | Compliance with ISO 10993-1 and related standards. |
  | Microbial Assessments | - Bioburden
• Endotoxin
• Sterility assurance | "Sterilization has been validated and is controlled... to provide a minimum SAL of 10-6." | Minimum SAL of 10-6; compliance with ISO 11135-1. |
  | Packaging Validation | - Visual Inspection
• Bubble Leak
• Seal Strength | "To evaluate integrity of the packaging configuration." (Implied successful evaluation) | Implicitly, maintaining package integrity after sterilization, environmental conditioning, and simulated shipping. |

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes for individual bench tests, biological safety tests, or packaging validation. It refers broadly to "comprehensive verification and validation activities." The data provenance is internal testing by the manufacturer, Medtronic Neurovascular, for a new medical device. This is prospective testing of the device being submitted for clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable to this type of device submission. There isn't "ground truth" established by experts in the context of an AI algorithm's performance. Instead, the "truth" is determined by established engineering specifications, biocompatibility standards, and functional performance requirements for a physical medical device.

4. Adjudication method for the test set

Not applicable. There's no human-in-the-loop performance or diagnostic adjudication involved for this physical device's non-clinical testing.

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, as this is not an AI device.

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

Not applicable, as this is not an AI device. The testing described is "standalone" in the sense that it's the device itself being tested, not an algorithm.

7. The type of ground truth used

For this medical device, the "ground truth" for the non-clinical tests would be:

• Engineering Specifications: Conformance to pre-defined dimensional, material, and performance requirements (e.g., inner diameter, lubricity, navigation).
• International Standards: Adherence to established standards for biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), and packaging integrity.
• Predicate Device Performance: Demonstrating that the subject device performs "at least as safe and effective as the predicate device."

8. The sample size for the training set

Not applicable, as this is not an AI device.

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

Not applicable, as this is not an AI device.

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