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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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The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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 describes the acceptance criteria and performance data for the APRO 70 Catheter and Alembic Aspiration Tubing. However, it does not contain information about a study proving device performance in the context of AI/ML or human reader performance. The device described is a medical catheter and aspiration tubing, not an AI/ML diagnostic or assistive device. Therefore, questions related to AI/ML specific acceptance criteria, test set characteristics (ground truth, expert adjudication, sample size for test/training sets with medical images), and MRMC studies are not applicable this document.

Here's the relevant information based on the provided text, focusing on the mechanical and biological aspects of the device, and addressing the applicable parts of your request.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Bench Testing: The text does not specify sample sizes (number of units tested) for each individual bench test. The source of this data is internal testing by Alembic, LLC.
• Animal Testing: Conducted on a "porcine model under Good Laboratory Practices (GLP)." The specific number of animals is not provided. This is prospective animal data.
• Biocompatibility Testing: The text does not specify sample sizes (e.g., number of guinea pigs for sensitization, number of rabbits for pyrogenicity). The provenance of this data is internal testing by Alembic, LLC.

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

This information is not applicable. The studies described are non-clinical (bench and animal) and do not involve human expert interpretation of medical images or data from a test set to establish ground truth in the context of an AI/ML device.

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

This information is not applicable as there is no mention of human expert adjudication for a test set in the context of an AI/ML device.

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

This information is not applicable. No MRMC study was conducted, as this device is a physical medical instrument, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is established by direct measurement against predefined specifications, observation of physical properties, and biological responses in animal and in-vitro models according to established laboratory protocols and standards (e.g., ISO, GLP). Examples include:

• Bench Testing: Direct measurements (dimensions, forces, leak rates), visual inspection for defects, functional assessment in simulated models.
• Animal Testing: Direct observation (fluoroscopy, compatibility), pathological assessment (histology), and functional evaluation (clot aspiration effectiveness) in a live biological system.
• Biocompatibility: Standardized biological tests assessing specific endpoints like sensitization, irritation, cytotoxicity, hemolysis, and systemic toxicity.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, so there is no training set for an algorithm.

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

This information is not applicable. There is no training set for an algorithm.

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