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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.

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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 Rist™ 071 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 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 the distal end 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 catheter has a nominal outer diameter of 0.084 inches and a nominal inner diameter of 0.071 inches. It is available in three working lengths: 95 cm, 100 cm, and 105 cm. 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.

The Rist™ 071 Radial Access Guide Catheter is a medical device intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The acceptance criteria and supporting studies are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The device underwent extensive testing, and the results consistently indicated that "All units met the acceptance criteria" or similar statements. Specific numerical acceptance criteria were not explicitly provided in the document for most tests, but the qualitative statement of meeting criteria is present.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test in the "Test Set." However, it repeatedly mentions "All units" or "All units met" indicating that a sufficient number of samples were tested to achieve statistical significance or to demonstrate compliance.

The data provenance is not specified in terms of country of origin. The studies are described as "Design verification and validation" (in-house testing) and based on applicable ISO/ASTM/USP standards, suggesting a laboratory-based, prospective testing approach. No mention of retrospective or prospective clinical data for the test set is present, as this is a pre-market submission focused on device performance rather than clinical outcomes.

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

For the "In vitro Simulated Use Study," it states that "A simulated interventional procedure was performed by physicians." The exact number of physicians or their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

For the "Radiopacity" test (from the predicate device), "Physicians were shown fluoroscopic images." Again, the specific number and qualifications of these physicians are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the tests. The results indicate a direct pass/fail or "met acceptance criteria" outcome, implying consensus on the directly measurable or observable results rather than a subjective assessment requiring adjudication. For physician-evaluated tests, the document indicates a general 'acceptance criteria met' without detailing disagreement resolution.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The studies focused on device performance characteristics rather than comparing human reader performance with or without AI assistance. The device itself is a physical catheter, not an AI-powered diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No standalone algorithm performance study was done. This is consistent with the nature of the device as a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for most performance tests was established by adherence to recognized international standards (ISO, ASTM, USP) and predefined internal specifications for various physical, chemical, and biological properties. This includes:

• Physical Measurements: Dimensional accuracy (ID, OD, length), tensile strength metrics, burst pressure values, torque limits, kink resistance thresholds.
• Chemical/Biological Properties: Biocompatibility assays (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility), chemical compatibility.
• Functional Performance: Leak testing, coating integrity, particulate count, simulated use performance, radiopacity (as confirmed by physicians).
• Sterility and Packaging Integrity: Demonstrated through sterilization validation and packaging tests.

8. Sample Size for the Training Set

No training set is applicable or mentioned. This device is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable as there is no training set for a physical device.

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Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial anewrysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Axium™ Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as "Axium™ device family"), consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The Instant Detacher (I.D.) is sold separately.

This document does not describe an AI/ML device and therefore does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance.

The document is a 510(k) premarket notification summary for the Axium™ Detachable Coil and Axium™ Prime Detachable Coil, which are neurovascular embolization devices. It describes a proposed change to the labeling concerning the accessory sheath (from femoral to arterial, allowing radial access) and the removal of certain peripheral vasculature indications for specific models.

The performance data presented are for bench testing of the physical device (e.g., ease of delivery, detachment reliability, retractability, retrieval) and 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." (Regarding animal and clinical data).

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes for test sets or data provenance for AI/ML model evaluation.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication methods for AI/ML test sets.
5. MRMC studies or human reader improvement with AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth used for AI/ML.
8. Sample size for AI/ML training set.
9. How ground truth for an AI/ML training set was established.

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1. The Solitaire™ X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.

2. The Solitaire™ X Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.

3. The Solitaire™ X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (

The subject 3 mm Solitaire™ X Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The subject 3 mm Solitaire™ X Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the subject 3 mm Solitaire™ X Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The subject 3 mm Solitaire™ X Revascularization Device also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and are intended for single- use only.

The Solitaire X Revascularization Device is designed to restore blood flow by removing thrombus in patients experiencing ischemic stroke. The device, specifically the 3mm variant, underwent several tests to demonstrate its performance and safety, leading to its substantial equivalence determination.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions a retrospective analysis of vessel sizes using the STRATIS registry data as a "clinical" study to support substantial equivalence. While it explicitly states this, it does not provide the sample size of this retrospective analysis.

• Data Provenance: The STRATIS registry data was "previously submitted in K193576," suggesting it's existing, likely multi-center, clinical trial or registry data. The country of origin is not specified but is likely international, given the nature of major stroke registries. It is retrospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the retrospective analysis of vessel sizes. Given it's a "retrospective analysis of vessel sizes," the ground truth would likely be based on imaging reports and clinical assessments already documented in the STRATIS registry by the original clinicians and radiologists involved in the patient care and data collection.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method for the retrospective analysis. As it relies on existing registry data, the "ground truth" would implicitly be the clinical diagnoses and measurements recorded at the time of the original study or patient care within the STRATIS registry.

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:

The document does not describe an MRMC comparative effectiveness study involving human readers with or without AI assistance. The described "clinical" study is a retrospective analysis of vessel sizes, not an evaluation of AI assistance for human readers.

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

The document does not describe a standalone performance study of an algorithm. The Solitaire™ X Revascularization Device is a physical mechanical thrombectomy device, not an AI or software algorithm. The "clinical" study mentioned is a retrospective analysis of vessel sizes, likely performed to understand the distribution of vessel sizes relevant to the device's application, rather than to evaluate an algorithm's performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the retrospective analysis, the ground truth would inherently be

• Imaging measurements and clinical diagnoses documented within the STRATIS registry data. This would include measurements of vessel sizes and characterization of occlusions based on imaging (e.g., CTA, MRA) and patient outcomes. It's a form of outcomes data and expert-reported imaging findings from the original clinical context.

8. The Sample Size for the Training Set:

The document does not mention a training set for an algorithm. The Solitaire™ X Revascularization Device is a physical medical device, not a machine learning model that requires training data.

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

As there is no mention of a training set for an algorithm, this question is not applicable.

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The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.

The Concerto Versa™ Detachable Coil is an embolization coil that consists of a platinum embolization coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately and was most recently cleared in K162704. The Concerto Versa™ Detachable Coil is supplied sterile and is intended for single-use only.

The provided document is a 510(k) summary for the Concerto Versa™ Detachable Coil. This document pertains to a medical device (an embolization coil) and does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, many of the requested categories, such as "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set," and "Ground truth for training set," are not applicable to this submission.

The document primarily focuses on demonstrating the substantial equivalence of the new device (Concerto Versa™ Detachable Coil) to a legally marketed predicate device (Concerto Detachable Coil System) through a series of bench tests and leveraging existing data from the predicate. The "acceptance criteria" are implicitly the passing results of these non-clinical tests.

Here's the information that can be extracted and how it relates to the request:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are generally "Pass" for each test, indicating that the device met the specified performance requirements. The document does not provide specific numerical criteria for each test beyond stating they "meet specification."

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

• Sample Size: The document does not explicitly state the specific number of coils or test replicates used for each bench test conducted on the Concerto Versa™ Detachable Coil. It states that "A subset of design verification testing was conducted."
• Data Provenance: The tests were "non-clinical bench testing." The document mentions "clinically relevant tortuosity model of the splenic and gastroduodenal arteries" which implies in-vitro testing. It also states that "GLP acute animal data was also leveraged from the predicate device," indicating some previous animal study data was used, but not for the subject device's new testing.
• Retrospective or Prospective: The testing performed for this submission would be considered prospective for the subject device, as it was specifically done for this 510(k) submission.

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

Not applicable. This is a medical device submission based on physical and mechanical performance testing, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication process is described as it's not a diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, this was not an MRMC comparative effectiveness study. It is a 510(k) submission for a non-diagnostic medical device.

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

Not applicable. This is a medical device, not an algorithm. The performance evaluation is based on mechanical and physical characteristics.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests is the defined engineering and material specifications for the device. For example, a coil's length must meet a certain specification, or its detachment time must be below a certain threshold. There's no "ground truth" derived from patient outcomes or expert consensus in the typical sense for a diagnostic device. Biocompatibility was evaluated against ISO 10993 standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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1. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
2. The Solitaire™ Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
3. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (

The Solitaire™ Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Revascularization Device is intended for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and are intended for single-use only.

The prompt asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.

Based on the provided information, the submission is for a labeling modification to reduce the recommended minimum vessel diameter for the Solitaire™ Revascularization Device, 4 mm device models. The core device design and Indications for Use remain unchanged from the predicate devices. Therefore, the performance criteria and studies focus on demonstrating that this labeling modification does not introduce new safety or effectiveness concerns.

Here's the breakdown of the information as requested:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The exact sample size for the retrospective analysis of the STRATIS registry data is not explicitly stated in the provided text. It mentions "a retrospective subgroup analysis."
• Data Provenance: The data is from the STRATIS registry, described as a retrospective analysis. The country of origin is not specified, but STRATIS (Stroke TreAtment with a Solitaire stent-retriever and Intravenous t-PA) is an international registry, so the data likely encompasses multiple countries.

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

This information is not provided in the text. The STRATIS registry would have had various clinical endpoints and adjudication processes, but the details of experts establishing ground truth for the specific retrospective subgroup analysis are not described.

4. Adjudication method for the test set:

This information is not provided in the text.

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 MRMC study was performed. The device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance was done as this is a medical device (thrombectomy device), not an imaging or diagnostic algorithm.

7. The type of ground truth used:

For the clinical performance, the ground truth would be based on patient outcomes data collected as part of the STRATIS registry (e.g., successful reperfusion rates, clinical disability scores, adverse event rates), as adjudicated in the original registry study design. For the bench tests, the ground truth is based on engineering measurements against predefined specifications.

8. The sample size for the training set:

• Training Set Sample Size: The concept of a "training set" in the context of device approval (especially for a physical medical device and a labeling modification) is not applicable in the same way it would be for an AI/ML algorithm. The device design and previous iterations would have been "trained" through extensive R&D and prior clinical trials for predicate devices, but there isn't a "training set" in the computational sense.
• The "retrospective analysis of subject vessel size was performed using the STRATIS registry data" to support the labeling modification, implying that this existing clinical data was used for validation rather than for "training" a new device or algorithm.

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

As above, the concept of a "training set" with ground truth establishment in the AI/ML sense is not applicable for this device submission. The existing clinical data from the STRATIS registry, which includes patient outcomes, would serve as the "ground truth" for evaluating the clinical performance of the device in smaller vessels. The establishment of this ground truth would have been defined by the STRATIS registry protocol, including clinical assessments and imaging.

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The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

The Marathon™ Flow Directed Micro Catheters are single-lumen, endhole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. Microcatheter may be used with stylet, guidewire or introducer sheath to increase the rigidity of the distal section during introduction into the guiding catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Marathon™ Flow Directed Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and bench testing.

However, the provided text DOES NOT contain information regarding:

• AI/Algorithm performance: This document is for a physical medical device, not an AI or algorithmic diagnostic tool.
• Acceptance criteria for an AI model: The acceptance criteria listed are for physical characteristics and performance of a catheter.
• Sample size for a test set or training set for an AI model: No AI model is being evaluated.
• Data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance: These are all concepts relevant to the evaluation of AI/ML-based medical devices or diagnostic algorithms, which are not the subject of this document.
• Effect size of human reader improvement with AI assistance: Not applicable.
• Type of ground truth used (pathology, outcomes data, etc.): Not applicable in this context.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI/ML model, nor can I answer the specific questions about AI model testing that were asked.

The document instead focuses on demonstrating the substantial equivalence of the Marathon™ Flow Directed Micro Catheter to a predicate device (K093750) through bench testing and biocompatibility assessments.

Here's the relevant information about the device's acceptance criteria and proven performance based on the provided text, re-framed to address the questions where applicable, but noting when the question is not relevant to this document.

1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):

2. Sample size used for the test set and the data provenance:

• This document is for a physical medical device and discusses bench testing, not an AI model's test set.
• Sample Size for Bench Testing:
  • Specific sample sizes for each bench test are not explicitly stated in this summary table, only the results. However, typical regulatory submissions for physical devices involve testing a statistically representative number of units.
• Data Provenance: Not applicable in the terms used for AI. The data originates from internal laboratory bench testing conducted by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular).
• Retrospective/Prospective: Not applicable in this context. These are lab tests.

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 evaluated through engineering bench tests and biocompatibility testing, not through expert-labeled diagnostic data for an AI model.

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

• Not applicable. This is for a physical device, not an AI test set requiring human adjudication.

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 document is about a physical medical device (catheter), not an AI system that assists human readers. No MRMC study was conducted or is relevant.

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 (expert consensus, pathology, outcomes data, etc.):

• For the biocompatibility tests, the "ground truth" is established by standard biological assays and the observation of cellular and blood responses against established safety thresholds.
• For the bench performance tests, the "ground truth" is the physical properties and performance characteristics of the catheter as measured against predefined engineering specifications and international standards (e.g., ISO 10555-1, ISO 80369). These are objective measurements.

8. The sample size for the training set:

• Not applicable. There is no AI model requiring a training set described here.

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

• Not applicable. There is no AI model or training set described here.

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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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