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The APRO 45 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 45 Catheter is also indicated for use as a conduit for retrieval devices.

The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 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 45 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 45 Catheter is provided with an Introducer Sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.

The provided FDA 510(k) clearance letter and summary for the APRO 45 Catheter focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing. It does not present information related to an AI/ML-driven medical device, a multi-reader multi-case (MRMC) study, or acceptance criteria for algorithmic performance.

Therefore, based solely on the provided text, it's not possible to fulfill most of the requested information points, as they pertain to the evaluation of AI/ML diagnostic or assistive devices. The document describes a physical medical device (catheter) and its non-clinical testing.

However, I will extract and present the acceptance criteria and performance information that is available from the provided text, primarily from the "Performance Data" section.

Acceptance Criteria and Device Performance for APRO 45 Catheter

The APRO 45 Catheter is a physical medical device, not an AI/ML driven diagnostic or assistive device. The acceptance criteria and performance data provided in the FDA 510(k) summary pertain to the physical and biological characteristics of the catheter, supporting its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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The APRO 45 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 45 Catheter to the aspiration pump.

The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 45 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 45 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 45 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 45 Catheter is available in lengths of 115, 125, 146, and 160 cm and is provided with an introducer sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.

The Alembic Aspiration Tubing connects the APRO 45 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 document is a 510(k) clearance letter and summary for the APRO 45 Catheter and Alembic Aspiration Tubing. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. As such, it does not contain information typically found in studies proving a device meets acceptance criteria related to clinical performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies.

Therefore, many of the requested sections will state that the information is not available or not applicable based on the provided document.

Acceptance Criteria and Reported Device Performance

The study supporting this 510(k) clearance relied on non-clinical bench testing to demonstrate that the APRO 45 Catheter and Alembic Aspiration Tubing meet predefined specifications and perform as intended. The acceptance criteria and reported device performance are detailed in Table 2 (Summary of Non-Clinical Bench Test Results) of the 510(k) Summary.

Table of Acceptance Criteria and Reported Device Performance (from Table 2):

Additional Requested Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify exact sample sizes for each bench test conducted. It refers to "the subject device and predicate device" for comparisons, implying relevant samples were used for laboratory testing.
   • Data Provenance: The data is from non-clinical bench testing and simulated use in anatomical neurovascular models, conducted by Alembic, LLC. It is by nature prospective experimental data, not patient-derived.

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

   • Not Applicable. This was a non-clinical bench study. The "ground truth" was established by predefined engineering specifications and international standards (e.g., ISO), not by expert human interpretation of medical data.

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

   • Not Applicable. As a non-clinical bench study, expert adjudication of medical results was not performed. Test results were assessed against predetermined engineering acceptance criteria.

4. 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. An MRMC comparative effectiveness study was not performed. This is a medical device (catheter and tubing), not an AI diagnostic algorithm, and its clearance was based on non-clinical performance and substantial equivalence to a predicate device.

5. 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. Therefore, "standalone" performance in the context of AI algorithms is not relevant. The device's performance was evaluated through bench testing.

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

   • For bench tests, the "ground truth" was defined by established engineering and material specifications, international standards (e.g., ISO 10555-1, ISO 80369-7, ISO 11135, ISO 10993-1), and acceptable performance in simulated models (e.g., clot retrieval from an anatomical neurovascular model). This is analogous to a "reference standard" from engineering specifications rather than clinical ground truth like pathology or outcomes.

7. The sample size for the training set:

   • Not Applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning. The device development process involves design, prototyping, and iterative testing, not AI model training.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set for an AI algorithm mentioned, the establishment of ground truth for such a set is not relevant.

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The APRO 55 Intermediate 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 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

The APRO 55 Intermediate Catheter is a single-lumen, braid and coil reinforced catheter. The 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 Intermediate 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 catheter is provided with an Introducer Sheath.

The FDA 510(k) clearance letter for the APRO 55 Intermediate Catheter (K250962) indicates that this is a catheter device, not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding acceptance criteria, study design, expert consensus, ground truth, and training data, which are typical for SaMD or AI-based medical devices, are not applicable to this submission.

The clearance is based on the device being substantially equivalent to a predicate device (APRO® 55 Catheter, K234115) with the only difference being in the packaging configuration. The substantial equivalence is supported by non-clinical testing, specifically bench testing for sterility and shelf-life, and a justification for not requiring new biocompatibility testing (due to material and processing similarity to previously cleared devices).

In summary, there is no AI component or related clinical performance study described in this document that would necessitate the details requested in your prompt.

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The APRO 55 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 55 Swift Catheter to the aspiration pump.

The APRO 55 Swift Catheter is a single-lumen, braid and coil reinforced catheter designed to remove thrombus from the vasculature using aspiration. It targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature, 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, and a radiopaque marker is at the distal end for fluoroscopic visualization. It is used with an aspiration pump connected via the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The catheter is available in lengths of 125 cm and 137 cm and is supplied with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 55 Swift Catheter to the aspiration pump and features a flow control valve with an ON/OFF switch. It is available in a single size.

This FDA 510(k) clearance letter details a device called the "APRO 55 Swift Catheter and Alembic Aspiration Tubing." However, this document does not describe a study that uses a test set, ground truth established by experts, or any of the elements typically found in a study demonstrating AI/ML device performance.

Instead, the submission for the APRO 55 Swift Catheter and Alembic Aspiration Tubing focuses on demonstrating substantial equivalence to a predicate device (K232971 APRO 55 Catheter and Alembic Aspiration Tubing) based on non-clinical performance data and a comparison of technological characteristics.

The core of this 510(k) is that the only difference between the subject device (APRO 55 Swift Catheter) and its predicate (APRO 55 Catheter) is the packaging configuration. The "Swift" designation appears to indicate a change in how the catheter is packaged (coiled in a dispenser tube) rather than a fundamental change in the device itself or its functionality.

Therefore, the requested information about acceptance criteria, test set, ground truth, expert consensus, MRMC studies, or standalone algorithm performance for this specific device cannot be extracted from the provided text because such studies were not conducted or deemed necessary for this particular submission.

The document explicitly states:

• "Performance bench testing was not conducted as sterility and shelf-life testing was sufficient for verification and validation of the change in packaging configuration."
• "An animal study was deemed not necessary to support the substantial equivalence of the subject device."
• "Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary."

In summary, the provided document does not contain the information required to answer your prompt, as it relates to a physical medical device (catheter) whose clearance was based on demonstrating equivalence through non-clinical bench testing for packaging changes, not on the performance of a diagnostic AI/ML algorithm.

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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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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

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