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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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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 (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

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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The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The provided text describes the 510(k) premarket notification for the Mirage™ and X-pedion™ Hydrophilic Guidewires, asserting their substantial equivalence to a predicate device. The information primarily focuses on bench testing rather than AI/ML algorithm performance. Therefore, many of the requested details, such as those related to AI model training, expert ground truth, and human reader studies, are not applicable or cannot be extracted from this document.

Here's the relevant information based on the provided text:

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

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

The document does not specify the exact sample sizes (number of guidewires) used for each bench test. The data provenance is from non-clinical bench testing conducted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (the applicant).

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

Not applicable. This is a medical device clearance based on substantial equivalence demonstrated through non-clinical bench testing, not an AI/ML algorithm requiring expert-established ground truth. The "ground truth" for these tests would be the physical properties and performance measurements of the guidewires against engineering specifications.

4. Adjudication method for the test set

Not applicable, as this is bench testing of physical device properties, not a study involving human interpretation of data where adjudication would be necessary.

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 for a physical medical guidewire, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.

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

Not applicable. This is for a physical medical guidewire.

7. The type of ground truth used

The "ground truth" for the bench tests would be the physical and mechanical specifications for guidewires, as referenced by standards such as ISO 11070 and USP <788>, as well as internal quality procedures (QP50324, TM0047). The tests evaluated observed performance against these predefined criteria.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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

Not applicable. There is no training set for a physical medical device.

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The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The provided text describes the 510(k) premarket notification for the Mirage™ Hydrophilic Guidewire and X-pedion™ Hydrophilic Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, rather than a study on an AI/ML-based medical device.

Therefore, the information required to answer most of your questions about acceptance criteria for an AI/ML device, sample sizes for AI test sets, expert ground truthing, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not present in this document.

However, I can extract information related to the acceptance criteria and performance data for the physical medical device as described:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):

The document details numerous non-clinical bench tests performed to demonstrate the safety and performance of the guidewires. The results consistently state that "The Mirage™ and X-pedion™ Hydrophilic Guidewires met the acceptance criteria for [Test Name]."

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Since this is a 510(k) submission for a non-AI/ML medical device, the following information is not applicable or not provided in the document:

1. Sample sizes used for the test set and the data provenance: Not an AI device, so no "test set" in the AI sense. Bench tests follow specific standards, implying sample sizes per those standards, but not explicitly stated here.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth for a physical device is established via standardized physical and chemical tests, not expert human interpretation of data for AI.
3. Adjudication method for the test set: Not applicable for non-AI bench testing.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For a physical guidewire, "ground truth" is typically defined by adherence to engineering specifications, material properties, and performance under simulated clinical conditions, verified through empirical testing following established ISO and USP standards.
7. The sample size for the training set: Not applicable; this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.

In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device requiring clinical validation for diagnostic or prognostic purposes.

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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 ische 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 (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

The Solitaire™ Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion 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 Solitaire™ Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ Platinum Revascularization Device also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and intended for single-use only.

The provided document describes the 510(k) premarket notification for the Solitaire™ Revascularization Device, seeking expanded indications for use. The acceptance criteria and the study used to demonstrate the device meets these criteria are detailed below.
It's important to note that this document is for a medical device, not an AI algorithm. Therefore, many of the requested fields related to AI-specific performance metrics (e.g., human readers improvement with AI, standalone algorithm performance, AI data provenance, training set size, etc.) are not applicable here. The study focuses on the clinical effectiveness and safety of the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device approval and not an AI algorithm, formal "acceptance criteria" in the sense of specific performance metrics with numerical thresholds are not explicitly stated as they would be for an AI submission. Instead, the study aims to demonstrate clinical safety and effectiveness for the expanded indications, primarily measured by patient outcomes. The key performance indicators are derived from the study endpoints.

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

• Test Set (Analysis Cohort - mITT):
  • Solitaire group: 32 subjects (from an initial 38 out of 182 total in DEFUSE 3 where Solitaire was the first device used)
  • Control group: 85 subjects (from an initial 90 out of 182 total in DEFUSE 3)
  • Total mITT: 117 subjects
  • Data provenance: The original DEFUSE 3 study was a multicenter, randomized, open-label trial (prospective). The document doesn't specify countries, but DEFUSE 3 was a US-based trial involving multiple sites across the United States. The analysis performed for this submission was a sub-analysis (post-hoc) of previously collected prospective clinical trial data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts involved in establishing "ground truth" for the test set. However, it mentions several elements that would have required expert interpretation:

• Blinded outcome assessment: The primary outcome (mRS at day 90) was evaluated by blinded assessors, implying qualified personnel.
• Central reading of imaging: mTICI scores and other imaging outcomes were assessed by a "central reader" and "core lab," which implies expert radiologists/neurologists, though specific numbers or qualifications are not provided in this document.
• RAPID software: Used for imaging analysis (ischemic core volume, mismatch ratio, mismatch volume), suggesting a standardized, software-assisted approach to image interpretation for eligibility and outcomes.

4. Adjudication method for the test set
The document does not explicitly describe an adjudication method like 2+1 or 3+1 for the test set. Instead, it states:

• "Blinded outcome assessment" for the modified Rankin Scale (mRS) at day 90.
• "Central reading" for mTICI and other imaging parameters by a "core lab."
  These practices typically involve a single expert or a panel of experts making determinations in a blinded fashion, but specific adjudication rules are not detailed.

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 submission is for a physical medical device (revascularization device), not an Artificial Intelligence (AI) algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or relevant to this submission.

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

• Not applicable. This submission is for a physical medical device, not an AI algorithm. Therefore, a standalone performance assessment of an algorithm was not performed. The "Solitaire" device itself is the intervention being evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference standard for evaluating the device's effectiveness and safety was based on:

• Clinical outcomes data: Primarily the Modified Rankin Scale (mRS) scores at 90 days, which are well-established clinical measures of functional independence after stroke.
• Mortality rates: All-cause mortality at 90 days.
• Safety event rates: Occurrence of symptomatic intracranial hemorrhage (sICH) and other adverse events.
• Imaging-based outcomes: Reperfusion rates (TICI scores), complete recanalization, infarct volume, and infarct growth, assessed by central readers/core labs, serving as objective measures of the device's action.

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device, not an AI algorithm. There is no "training set" in the context of machine learning. The clinical data from the DEFUSE 3 study served as the primary evidence for the device's clinical performance.

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

• Not applicable. As noted above, there is no "training set" for an AI algorithm in this context. The "ground truth" for the clinical study (DEFUSE 3) involves established clinical endpoints (mRS, mortality, sICH) and imaging assessments by expert clinicians and core labs, as described in point 7.

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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.

The Solitaire™ 4 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 4 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 Solitaire™ 4 Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ 4 Revascularization Device also features radiopaque markers along the circumference of the working length of the device. The devices are supplied sterile and are intended for single-use only.

The provided text is a 510(k) Summary for the Solitaire™ 4 Revascularization Device, which is a medical device for treating acute ischemic stroke. It describes the device, its indications for use, comparison to a predicate device, and performance data.

However, the questions posed in your request (Acceptance Criteria, Study Details, Sample Size, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Details) are typically associated with the evaluation of AI/ML-driven medical devices that require demonstration of algorithmic performance against a defined ground truth.

The Solitaire™ 4 Revascularization Device is a physical mechanical thrombectomy device. The performance data provided in this document focuses on bench testing (non-clinical) to ensure the device's physical properties, such as length, force, particulate generation, durability, and tensile strength, meet specifications. It explicitly states:

• "No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device."
• "Bench testing confirmed that the modifications to Solitaire™ 4 met product specifications and do not raise new questions on the safety and effectiveness of the device."

Therefore, most of the information requested, which pertains to AI/ML device validation, is not applicable to this traditional medical device submission.

Here's a breakdown of what can be extracted from the document based on your questions, and what cannot:

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

The document provides a summary of non-clinical bench tests. It states that "Acceptance criteria met" for each test, but it does not specify the numerical acceptance criteria themselves or the reported performance values. It only confirms that the device passed.

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

The document doesn't provide specific sample sizes (e.g., number of devices tested) for the bench tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective, as this is laboratory bench data, not clinical 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 as typically understood for AI/ML models (e.g., medical image annotations) is not relevant for the bench testing of a physical device. The "ground truth" here is engineering specifications and physical measurements.

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

Not applicable. This is not a process that requires multi-reader adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No, an MRMC study was explicitly not done. The document states: "No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device."

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the bench tests is the engineering specifications and performance standards set for the device's physical properties. For example, a "System Tensile" test has a pre-defined acceptance criterion for the amount of force the device must withstand.

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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