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The APRO 70 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing 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 Alembic Aspiration Tubing is intended to connect the APRO 70 Swift Catheter to the aspiration pump.

The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Swift Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Swift Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Swift Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Swift Catheter is available in lengths of 125 cm. 132 cm, and 135 cm and is provided with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 70 Swift Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.

The provided text describes the acceptance criteria and the study results for the APRO 70 Swift Catheter and Alembic Aspiration Tubing. It is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance data, rather than a clinical trial report. Therefore, some of the requested information, particularly regarding clinical studies, human readers, and effect sizes, is not applicable or available in this document.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily from non-clinical bench testing.

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The APRO 70 Swift Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 70 Swift Catheter is also indicated for use as a conduit for retrieval devices.

The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 70 Swift Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 70 Swift Catheter is provided with an Introducer Sheath.

This document is a 510(k) Premarket Notification from the FDA regarding the APRO 70 Swift Catheter. It focuses on demonstrating the device's substantial equivalence to a predicate device, primarily through non-clinical performance data.

Here's a breakdown of the information requested, based on the provided document:

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

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The APRO 55 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Catheter is also indicated for use as a conduit for retrieval devices.

The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 55 Catheter is provided with an Introducer Sheath.

The provided document is a 510(k) summary for a medical device (APRO 55 Catheter) seeking FDA clearance, not a study report detailing acceptance criteria for an AI/ML device. Therefore, it does not contain information typically found in such a study, such as acceptance criteria for machine learning performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets in an AI context, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document describes non-clinical bench testing for a physical medical catheter, including mechanical, material, and biocompatibility tests. The "acceptance criteria" mentioned are for these engineering and biological tests, not for an AI/ML diagnostic or predictive model.

Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and study details based on the provided text.

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The APRO 55 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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 Alembic Aspiration Tubing is intended to connect the APRO 55 Catheter to the aspiration pump.

The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 55 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 55 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 55 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 55 Catheter is available in lengths of 125 cm and 137 cm and is provided with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 55 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.

Here's a summary based on the provided FDA 510(k) document, focusing on acceptance criteria and study details:

Device: APRO 55 Catheter and Alembic Aspiration Tubing

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed are primarily for non-clinical bench tests. The reported device performance uniformly states that the APRO 55 Catheter (and Alembic Aspiration Tubing where applicable) met the acceptance criteria.

Biocompatibility Tests:

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The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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 Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.

The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 70 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.

The provided text is a 510(k) summary for the APRO 70 Catheter and Alembic Aspiration Tubing. This type of submission is for medical devices, not AI/ML-based software as a medical device (SaMD). Therefore, the questions regarding acceptance criteria and study data typical for AI/ML performance (e.g., ground truth establishment, expert adjudication, MRMC studies, training set details) are not applicable to this document.

The document describes the device, its intended use, and demonstrates substantial equivalence to a predicate device through non-clinical bench testing. The performance data is focused on the physical characteristics and functional integrity of the catheter and tubing.

Here's an analysis based on the information provided for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of devices tested) for each non-clinical bench test. It states "Alembic performed non-clinical bench testing in accordance with design controls, protocol, and test methods". The data provenance is non-clinical bench testing; it's not patient-derived data, so country of origin or retrospective/prospective distinctions are not applicable in the typical sense for clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth as understood in AI/ML is not relevant for this type of medical device bench testing. The "ground truth" for these tests is defined by established engineering and material science specifications, and ISO standards (e.g., ISO 10555-1), not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process described for these bench tests. The results are based on quantitative measurements and observations against pre-defined engineering acceptance criteria.

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

No. This is a medical device, not an AI/ML-based software. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable. The study presented here is focused on demonstrating the physical and functional performance of the catheter and tubing, and its substantial equivalence to a predicate device through non-clinical bench testing.

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

Not applicable. This is not an AI/ML algorithm. The performance documented is that of the physical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this medical device is based on:

• Pre-defined engineering and material specifications.
• Compliance with recognized standards (e.g., ISO 10555-1).
• Functional performance criteria observed during bench testing (e.g., freedom from kinking, maintaining vacuum).
• Comparison to the performance of a legally marketed predicate device in some tests (e.g., Particulate, Delivery and Retrieval Force, Tip Buckling Force sections mention comparison to a predicate).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML 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 medical device.

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