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The ERIC Retrieval Device is indicated to restore blood flow in the neurovasculature by removing thrombus 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.

Device Description

The ERIC™ (Embolus Retriever with Interlinked Cage) Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by removing clots from vasculature in patients suffering from acute ischemic stroke. The device consists of retrieval spheres secured on a pusher wire that are designed to capture and remove blood clots from the neurovasculature. The device is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from the vessel.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the ERIC Retrieval Device:

I. Acceptance Criteria and Reported Device Performance

Test Description / Outcome	Acceptance Criteria (Implied)	Reported Device Performance
Bench/Verification Testing
Dimensional Testing (Expanded Diameter & Device Overall Length)	Device attributes (overall device length and expanded outer diameter (OD) of the shaped section) must meet specified criteria and not raise new questions regarding safety and efficacy compared to predicate.	Pass. The longer overall length and smaller OD of the subject device offerings do not affect the performance of the device.
Fluoroscopic Guidance Marker Testing (Radiopacity)	Markers must be sufficiently visible under fluoroscopy.	Pass. Both subject and predicate devices are sufficiently visible under fluoroscopy.
Advance/Retraction Force Testing	Advance and retract forces in a tortuous model must be comparable to predicate devices.	Pass. The advance and retract forces of the subject device were comparable with the forces measured for the predicate device.
Re-Sheathing Testing	Ability to re-sheath the device must be comparable to predicate devices.	Pass. The ability to re-sheath the subject device is comparable to that of the predicate device tested.
Radial Force Testing	Radial force must be comparable to predicate devices.	Pass. The radial force of the subject device is comparable to that of the predicate device tested.
Tensile Strength Testing	Peak tensile strength to failure in different sections must be comparable to predicate devices.	Pass. The system tensile strength of the subject device is comparable to that of the predicate device tested.
Kink Resistance Testing	Kink resistance must be equivalent to predicate devices.	Pass. Kink resistance of the subject device is equivalent to that of the predicate device tested.
Austenite Finish (Af) Testing	Af temperature must be less than product use temperature (body temperature) to satisfy clinical application requirements.	Pass. The Af temperature of the subject device is less than the product use temperature (body temperature) and, thus, satisfies requirements for clinical applications.
Simulated Use/Performance Testing	Ability to reliably deploy and use the device in a tortuous benchtop model must be comparable to predicate devices.	Pass. Simulated use testing was comparable with that of the predicate device.
Corrosion Resistance Testing	Metallic components intended for fluid path contact must show no signs of corrosion.	Pass. Corrosion resistance testing of the subject device showed no signs of corrosion.
Particulate Evaluation Testing	Particulate generation in a tortuous benchtop model must be comparable to predicate devices.	Pass. Particulate evaluation was comparable with that of the predicate device.
Torque Response Testing	Core wire of the subject device must rotate freely with the proximal sphere and have equivalent torqueability compared to the predicate device.	Pass. Torque response testing indicated that the core wire of the subject device rotates freely with the proximal sphere and, thus, has equivalent torqueability compared to the predicate device.
Biocompatibility Evaluation	Device must be non-cytotoxic, non-irritating, non-sensitizing, systemically non-toxic, non-pyrogenic, non-hemolytic, non-activating (complement activation), non-thrombogenic, and have no effect on coagulation of human plasma and hematological parameters. (Compliance with ISO 10993-1 and FDA Biocompatibility Guidance)	Pass. Demonstrated non-cytotoxic, non-sensitizer, non-irritating, systemically non-toxic, non-pyrogenic, non-hemolytic, no effect on coagulation of human plasma, non-activating, no effect on hematological parameters, and non-thrombogenic.
Sterilization, Shelf-Life, and Packaging Integrity	Achieve a minimum sterility assurance level (SAL) of 10^-6 for electron beam sterilization (specified as 10^-9) and bacterial endotoxin < 2.15 EU/device. Packaging must maintain functionality and sterility for the indicated shelf-life.	Pass. Successfully validated electron beam sterilization process achieving a minimum SAL of 10^-9 with bacterial endotoxin < 2.15 EU/device. Shelf-life studies per ASTM F1980 conducted, establishing product and packaging functionality and sterility.
Animal Testing (Safety & Performance)	Tissue response, perforation/dissection, and downstream thromboembolic/ischemic injury must be comparable to the predicate device. Devices must be safe and equivalent to the predicate device.	Pass. Histological evaluation showed similar tissue response to test and control devices. No evidence of perforation or dissection. No evidence of downstream thromboembolic or ischemic injury. Chronic study animals remained healthy. Study endpoints met; ERIC devices shown to be safe and equivalent.
Clinical Study - Primary Effectiveness Outcome (mTICI 2b-3)	The primary effectiveness outcome (successful reperfusion, mTICI 2b-3) success rate for the ERIC device cohort must be statistically non-inferior to the mTICI rate for the Trevo/Solitaire cohort.	82.2% (76.9-87.5%) for ERIC (166/202) vs. 80.7% (78.2-83.1%) for Trevo/Solitaire (842/1044). When considering missing subjects/rescue as failures: 63.1% for ERIC (130/206) vs. 60.4% for Trevo/Solitaire (639/1058). Conclusion: Substantially equivalent.
Clinical Study - Primary Safety Outcome (sICH within 24-48h)	The rate of occurrence of symptomatic intracerebral hemorrhage (sICH) within 24-48 hours post-procedure for the ERIC device cohort must be statistically non-inferior to the sICH rate for the Trevo/Solitaire cohort.	4.1% (1.1-7.2%) for ERIC (7/169) vs. 8.4% (6.6-10.2%) for Trevo/Solitaire (81/965). (Note: A higher proportion of missing follow-up CT/MRI in the ERIC group means the actual sICH rate could be higher than the reported CI). Conclusion: Substantially equivalent.
Clinical Study - Secondary Outcome (Good Clinical Outcome - 90-day mRS 0-2) (for substantial equivalence support)	The 90-day mRS of the ERIC arm must be substantially equivalent to the control arm based on available follow-up data.	49.3% (40-57.7%) for ERIC (67/136) vs. 44.9% (41.7-48.2%) for Trevo/Solitaire (413/919). Conclusion: Substantially equivalent.

II. Sample Size and Data Provenance (Clinical Study)

Sample Size for Test Set:
- ERIC Device Cohort: N = 206 patients
- Trevo/Solitaire Cohort: N = 1058 patients
Data Provenance: Prospective, multi-center, observational study (ETIS - Endovascular Treatment in Ischemic Stroke follow-up Evaluation Observational Cohort Study, NCT03776877). Data collected from all 7 active sites from the beginning of the study to September 2018.
Country of Origin: France.
Retrospective or Prospective: Prospective.

III. Number of Experts and Qualifications (Clinical Study Ground Truth / Patient Selection)

"All patients were selected for endovascular thrombectomy based on evaluation by a multi-disciplinary team of physicians including neuroradiologists."
Number of Experts: Not explicitly stated, but implies a team approach.
Qualifications of Experts: Included "neuroradiologists." Specific years of experience are not mentioned.

IV. Adjudication Method (Clinical Study Test Set)

The document does not explicitly describe an adjudication method for the test set outcomes (mTICI, sICH, mRS). This was an observational study based on data collected over time. Outcomes would have been determined by the treating physicians and documented in the study records.

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

No, a MRMC comparative effectiveness study was not done. The clinical study compared the performance of the ERIC device against predicate devices (Trevo/Solitaire) in terms of patient outcomes (reperfusion rates, sICH, mRS) as measured in standard clinical practice, not specifically assessing the improvement of human readers with AI assistance. This device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.

VI. Standalone (Algorithm Only) Performance

Not applicable. This device is a medical device (mechanical thrombectomy device), not an algorithm or AI. The performance metrics presented are for the device's clinical efficacy and safety when used by medical professionals, not a standalone algorithm.

VII. Type of Ground Truth Used (Clinical Study)

Clinical Outcomes/Expert Assessment and Imaging:
- Successful reperfusion (mTICI 2b-3): Based on angiographic imaging assessed by clinical experts (likely neuroradiologists or interventionalists within the clinical setting).
- Symptomatic Intracerebral Hemorrhage (sICH): Based on clinical assessment and follow-up CT scan/MRI, interpreted by medical professionals.
- Good Clinical Outcome (90-day mRS 0-2): Modified Rankin Scale (mRS) score assessed clinically by medical professionals at 90 days.

VIII. Sample Size for Training Set

Not applicable. The ERIC Retrieval Device is a hardware medical device, not an AI/ML algorithm that requires a training set. The clinical study investigated its performance against established predicate devices.

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

Not applicable. As described above, there is no training set for this type of hardware medical device.

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