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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 (

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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Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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.

Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) 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.

Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra 3D Revascularization Device is an additional component to the currently available Penumbra System. The Penumbra System's fundamental mechanism of action is aspiration. Aspiration draws clot into the Penumbra Reperfusion Catheter to remove the clot. The 3D Revascularization Device is designed to assist the Reperfusion Catheter with thrombus removal if needed. The device is provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the 510(k) summary for the Penumbra 3D Revascularization Device, including a clinical study to assess its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria for this medical device is demonstrated through a non-inferiority clinical study. The primary effectiveness endpoint was reaching a modified Thrombolysis In Cerebral Infarction (mTICI) score of 2-3.

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

For the clinical study (Penumbra 3D Trial):

• Test Set (Primary Effectiveness Cohort):
  • All Patients: N=150
  • 3D / Penumbra System arm: N=74
  • Penumbra System alone arm: N=76
• Data Provenance: The study was a prospective, randomized, concurrent controlled, multi-center study. The text does not explicitly state the country of origin but typically such trials for FDA approval involve sites within the US or internationally recognized centers.

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

• Ground Truth for Effectiveness (mTICI score): Angiographic results were adjudicated by an independent Core Laboratory. The number and specific qualifications of the experts within this laboratory are not detailed in the provided text.
• Ground Truth for Safety (SAEs): Serious adverse events (SAEs) were adjudicated by a Clinical Events Committee. The number and specific qualifications of the experts within this committee are not detailed.

4. Adjudication Method for the Test Set

• Effectiveness (mTICI score): "Angiographic results were adjudicated by an independent Core Laboratory." The specific method (e.g., 2+1, 3+1) is not explicitly stated, but the use of a "Core Laboratory" implies a standardized and expert review process.
• Safety (SAEs): "The primary safety endpoint was adjudicated by a Clinical Events Committee." Similar to effectiveness, the specific method is not detailed, but external committee adjudication suggests a robust review.

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

• No, a "multi-reader multi-case (MRMC) comparative effectiveness study" involving human readers improving with AI vs without AI assistance was not conducted or described. This study directly compared two device interventions (3D/Penumbra System vs. Penumbra System alone) and evaluated their impact on patient outcomes. The device itself is not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This question is not applicable as the device is a medical instrument (revascularization device) used directly in a procedure, not an algorithm, and by its nature requires human intervention to be operated. It does not have a standalone "algorithm-only" performance as an AI system would.

7. Type of Ground Truth Used

• Effectiveness: The primary effectiveness ground truth was the modified Thrombolysis In Cerebral Infarction (mTICI) score, which is an angiographic assessment of reperfusion, indicating the level of blood flow restoration in the occluded vessel. This was determined by an independent Core Laboratory.
• Safety: The ground truth for safety involved the reporting and adjudication of Serious Adverse Events (SAEs) by a Clinical Events Committee.
• Secondary Endpoints: Functional outcome at 90 days was assessed using the modified Rankin Scale (mRS) score, which is a measure of neurological disability or dependence in daily activities.

8. Sample Size for the Training Set

• The document describes a clinical trial (Penumbra 3D Trial) that enrolled patients for a comparative effectiveness study. This is an evaluation study, not a study that involves a "training set" in the context of machine learning. Therefore, a training set sample size is not applicable here. The device was likely developed and refined through engineering studies, bench testing, and animal studies (pre-clinical data) before the human clinical trial.

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

• As a "training set" in the machine learning sense is not applicable to an evaluation of this physical medical device, this question is not relevant. The device's design and functionality were established through the non-clinical data (biocompatibility, bench-top testing, animal studies) and then validated in the clinical trial.

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The Solitaire™ Platinum Revascularization Device is intended 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed 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 provided text describes the Solitaire™ Platinum Revascularization Device and its performance data to establish substantial equivalence with a predicate device. The information primarily focuses on bench testing and biocompatibility rather than clinical studies involving human or animal subjects for the new devices (4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The table below combines information from multiple sections of the document to present the acceptance criteria and the conclusion for each test. The "Reported Device Performance" column reflects the conclusion stated in the document, which consistently indicates that the device met the acceptance criteria and is substantially equivalent to the predicate.

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