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The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Zoom 88 Large Distal Platform and Zoom 88 Large Distal Platform Support are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform (LDP) Catheters include the Zoom™ 88 Large Distal Platform, Zoom™ 88 Large Distal Platform Support, and TracStar™ LDP Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This FDA 510(k) Summary describes a device (TracStar LDP Large Distal Platform, Zoom 88 Large Distal Platform, Zoom 88 Large Distal Platform Support) intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The submission is for a line extension and manufacturing process improvements, referencing a predicate device (K212224). Therefore, the study details provided are focused on demonstrating substantial equivalence to the predicate device, rather than a de novo clinical trial for a new product with absolute performance metrics against a disease state.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are based on the performance of the device against a set of predefined specifications derived from an existing standard (ISO 10555-1 for catheter performance) and internal engineering requirements. The reported device performance is simply "Pass" for all tested attributes, indicating that the subject device met these specifications.

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

The document does not specify the exact sample sizes used for each bench and laboratory test. It states that "Bench and laboratory (in-vitro) testing was completed" and references "simulated neurological model" and "simulated use testing," indicating an in-vitro experimental setting.

Data Provenance: The data is generated from in-vitro bench and laboratory testing conducted by the manufacturer, Imperative Care, Inc. The country of origin of this data is not explicitly stated, but it is implied to be internal testing. The data is retrospective in the sense that it evaluates the performance of the manufactured devices against pre-established specifications.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" established by experts (e.g., radiologists) is typically relevant for studies validating diagnostic or AI-driven devices against clinical outcomes or expert interpretation, such as in an MRMC study. This submission focuses on the physical and mechanical performance of a medical device (catheter) through bench testing.

4. Adjudication Method for the Test Set

Since the evaluation is based on objective measurements and predefined specifications in bench testing (e.g., absence of kinking, passage through a simulated model), there is no adjudication method as typically understood in clinical or expert-reviewed studies. The "Pass/Fail" results are determined by whether the device meets the quantitative and qualitative requirements of the test specifications.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not an AI-driven or diagnostic device that involves human reader interpretation. Consequently, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (catheter), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the pre-established physical and mechanical performance specifications laid out in the test attributes and derived from standards like ISO 10555-1 and internal engineering requirements. It is a benchmark of expected functional performance, rather than a clinical or pathological diagnosis.

8. The Sample Size for the Training Set

This question is not applicable as this is not a machine learning or AI-driven device. There is no concept of a "training set" for physical device performance testing.

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

This question is not applicable as this is not a machine learning or AI-driven device.

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The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Radial 088 Access System (Radial 088 Access System) consists of a single lumen catheter (Radial 088 Access Catheter) and a 6F Dilator intended to provide ease of access to the peripheral, coronary and neuro vasculature using a transradial access (TRA) approach.

The Radial 088 Access Catheter consists of a single lumen, braid and coil reinforced, variable stiffness catheter constructed using medical grade polymers. The catheter features include a standard luer hub on the proximal end and an atraumatic angled tip on the distal end. The distal section is covered in a lubricious hydrophilic coating for ease of tracking through tortuous vasculature to reach the target location. The distal tip has a radiopaque marker to provide the user with visual confirmation of the distal tip location during tracking and placement under fluoroscopy.

The Radial 088 Access Catheter is offered in working lengths of 95 cm, 105 cm, and 110 cm. The catheter has a proximal and distal inner diameter (ID) of 0.088" and is compatible with ≤ 0.038" diameter guidewires and 6F interventional devices having a minimum device length of 120 cm. The catheter has a distal outer diameter (OD) of 0.107" (2.7 mm) and a proximal OD of 0.110" (2.8 mm): the luer hub on the proximal end is compatible with Rotating Hemostasis Valves (RHVs) having a standard luer connector.

The 6F Dilator is a single lumen dilator with a tapered tip constructed of medical grade polymers. The 6F Dilator includes a standard luer hub on the proximal end which is compatible with standard luer lock devices (e.g., syringes). The 6F Dilator has an ID of 0.039" minimum, an OD of 0.083"-0.086" and is offered in a working length of 130 cm (± 2 cm).

The provided text describes a 510(k) summary for the "Imperative Care Radial 088 Access System." The document extensively outlines the device, its intended use, comparison to a predicate device, and performance data supporting its substantial equivalence. However, it does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in terms of clinical performance measures such as sensitivity, specificity, accuracy, or diagnostic effectiveness.

The document focuses on engineering and material-based performance tests commonly used for medical devices like catheters, ensuring they meet specified physical and material properties. It does not involve a study with a "test set" in the context of diagnostic or AI-driven medical devices (which would typically involve patient data and expert ground truth). Therefore, many of the requested items, particularly those related to diagnostic performance and AI studies, cannot be extracted from this document.

Here's what can be extracted based on the provided text:

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

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

The document describes bench and laboratory (in-vitro) testing. It does not involve a "test set" of patient data in the sense of a clinical or AI diagnostic study. The testing was conducted in a simulated neurological model for trackability. No specific sample sizes for these bench tests are provided, nor is the country of origin or whether it was retrospective/prospective in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a catheter, and its performance evaluation involves engineering and biocompatibility testing, not expert-adjudicated ground truth on patient data.

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

Not applicable. This device is a catheter, and its performance evaluation involves engineering and biocompatibility testing, not expert adjudication on patient data.

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 device is a catheter, not an AI-driven diagnostic tool.

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

Not applicable. This device is a catheter, not an AI algorithm.

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

The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO 10555-1 for catheter performance, ISO 80369-7 for luer compatibility, ASTM F1980-16 for accelerated aging) and biocompatibility testing guidelines. It's about meeting physical, chemical, and biological specifications rather than a diagnostic 'truth.'

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm that would have a "training set."

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

Not applicable. This document describes a physical medical device, not an AI algorithm.

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The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Zoom 88 Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP Large Distal Platform and Zoom™ 88 Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This document describes the premarket notification for the Imperative Care TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform, which are guide catheters. The submission is based on substantial equivalence to predicate devices, meaning extensive new studies were not required. The provided text details the acceptance criteria and study findings 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 explicitly state the specific sample sizes (number of units tested) for each individual bench and laboratory test. It generally refers to "bench and laboratory (in-vitro) testing." The data provenance is in-vitro, conducted in a laboratory setting. There is no information regarding country of origin of the data or if it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.

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

This information is not provided. For performance testing of a medical device like a catheter, "ground truth" is typically established by physical measurements, engineering specifications, and adherence to recognized standards (like ISO 10555-1), rather than expert consensus on interpretive data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers to resolve discrepancies. The performance tests described here are objective, pass/fail engineering tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (catheter) and relies on bench and laboratory testing for substantial equivalence, not comparative clinical effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the device described. The TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform are physical guide catheters, not algorithms or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to report.

7. The Type of Ground Truth Used

For the bench and laboratory tests, the "ground truth" is based on pre-defined engineering specifications and performance standards, particularly ISO 10555-1 for catheters. The results are objective measurements against these established criteria, leading to a "Pass" or "Fail" outcome.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical catheter, not an AI/ML algorithm that requires a training set. The substantial equivalence pathway relies on demonstrating that the new device performs similarly to a predicate device through bench testing, not on learning from a dataset.

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

This information is not applicable, as there is no training set for a physical medical device.

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The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), 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.

The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

The ZOOMTM 71 Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.

The ZOOM 71 Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the ZOOM 71 Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The ZOOM 71 Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

The ZOOM Aspiration Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM 71 Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration Tubing is made of common medical grade polymers.

The acceptance criteria and study proving the device meets them are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify the exact sample sizes used for each bench test. The data provenance is laboratory bench testing conducted by Imperative Care, Inc.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The study involved bench testing against engineering specifications, not clinical evaluation requiring expert ground truth.

4. Adjudication Method for Test Set:

Not applicable, as this was bench testing against engineering specifications.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The data presented is from bench testing to demonstrate substantial equivalence to a predicate device.

6. Standalone Algorithm Performance:

Not applicable. This device is a reperfusion catheter and aspiration tubing, not an AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this study was engineering specifications and performance standards (e.g., ISO 10555-1) used for bench testing.

8. Sample Size for Training Set:

Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for a physical medical device.

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The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), 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.

The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

The ZOOM™ Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.

The ZOOM Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1.

The ZOOM Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the ZOOM Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The ZOOM Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

The ZOOM Aspiration Tubing is offered in one model with the features indicated in Table 2.

The ZOOM Aspiration Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration Tubing is made of common medical grade polymers.

The provided document describes the acceptance criteria and a study conducted for the ZOOM Reperfusion Catheters and ZOOM Aspiration Tubing (K210996).

Here's a breakdown of the requested information:

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

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

The document primarily describes bench testing to evaluate differences between the subject and predicate devices. No information about sample sizes for a clinical test set is provided in this submission summary, nor details about data provenance (country of origin, retrospective/prospective). This type of submission (510(k) Special) largely relies on demonstrating substantial equivalence through engineering and performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The study described is bench testing, not a clinical study involving experts to establish ground truth.

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

Not applicable. This was bench testing, not a clinical study requiring adjudication.

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. No MRMC study or AI component is mentioned.

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

Not applicable. This submission is for medical devices (catheters and tubing), not an algorithm or AI.

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

For the bench testing, the "ground truth" was the predefined performance specifications and test methods based primarily on catheter performance standard ISO 10555-1. The devices were tested against these engineering and functional standards.

8. The sample size for the training set

Not applicable. This is a medical device submission based on bench testing of physical products, not an AI or machine learning model that would require a training set.

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

Not applicable. As above, this is not an AI/ML submission.

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The TracStar Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The ZOOM 88 and ZOOM 88-T Large Distal Platform are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP, Zoom™ 88 LDP and Zoom™ 88-T LDP. The LDP Catheters are 0.038" or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This document is a 510(k) Summary for a medical device (TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform). It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study with human readers or AI algorithms for diagnostic purposes. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and performance specifications for the physical catheter device, not a diagnostic algorithm's performance on medical images.

Therefore, many of the requested items related to AI/MRMC studies, ground truth establishment, expert adjudication, and training/test set sample sizes are not applicable here.

However, I can extract information related to the device's physical performance testing.

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

The document provides a table of "Test Attributes" (which serve as acceptance criteria) and the "Results". All tests passed their respective specifications.

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

The document describes "Bench and Laboratory (in-vitro) testing" and "simulated neurological model". This indicates the testing was conducted in a lab environment using physical devices. There is no information provided about the specific number of devices tested for each attribute (sample size for the test set) or the country of origin of this test data. The testing would be prospective in nature as it's active testing performed to gather data for regulatory submission.

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

Not applicable. This is a physical device performance test, not a diagnostic imaging study requiring expert interpretation or ground truth establishment in the healthcare sense.

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

Not applicable. This is a physical device performance test.

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 is a physical device, not an AI diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" here is determined by engineering specifications and objective measurements against those specifications in a laboratory setting. For example, for "Freedom from Leakage", the ground truth is simply "no liquid leakage" or "no air leakage" under specified conditions. For "Kink Resistance", the ground truth is "no permanent deformation".

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that undergoes a training phase.

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

Not applicable. As above, this is a physical medical device, not a machine learning model.

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The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), 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.

The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

The ZOOM Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.

The ZOOM Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.

The ZOOM Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the ZOOM Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The ZOOM Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

The ZOOM Aspiration Tubing is offered in one model with the features indicated in Table 2.

The ZOOM Reperfusion Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration tubing is made of common medical grade polymers.

The provided text describes the performance data for the ZOOM Reperfusion Catheters and ZOOM Aspiration Tubing (Gen 2), comparing it to a predicate device (Gen 1). However, it does not include information about AI/algorithm-specific acceptance criteria or studies. The documentation focuses on demonstrating substantial equivalence to a previous version of the same medical device through bench and lab testing, biocompatibility, sterilization, and shelf-life testing.

Therefore, many of the requested sections related to AI/algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative "Pass" or "Comparable to predicate/competitive products" based on the described tests. The reported performance is summarized as "Pass" for all validated attributes, indicating that the device meets its internal specifications and is comparable to the predicate.

ZOOM Reperfusion Catheter

ZOOM Aspiration Tubing

Biocompatibility Testing (ZOOM Reperfusion Catheter)

Sterilization Validation (ZOOM Reperfusion Catheter & ZOOM Aspiration Tubing)

Packaging Validation (ZOOM Reperfusion Catheter & ZOOM Aspiration Tubing)

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

• Sample Size: The document states that "The largest and smallest diameter catheters were tested for both the subject and predicate devices." Exact numerical sample sizes for each test are not specified, but the tests were performed on representative samples of the devices.
• Data Provenance: The studies were bench and lab testing. This means the tests were conducted in a laboratory setting on the physical devices themselves, not on patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the clinical data sense. The testing was conducted by Imperative Care Inc.

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

Not applicable. The reported studies are bench and lab testing of physical device performance, biocompatibility, sterilization, and packaging. There is no "ground truth" in the diagnostic sense or involvement of medical experts for interpreting diagnostic results. The acceptance criteria are based on engineering specifications and recognized consensus standards (e.g., ISO, ASTM).

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

Not applicable, as this is related to clinical interpretation or AI model output validation, which is not covered in this document.

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

No. This document describes the performance of a physical medical device (catheter and aspiration tubing), not an AI-powered diagnostic or assistive tool.

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

No. This document does not describe an algorithm.

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

Not applicable. The "ground truth" for these engineering and biological tests are the established specifications, standards (e.g., ISO, ASTM), and comparison to the predicate device's performance.

8. The sample size for the training set

Not applicable. There is no AI model or training set described in this document.

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

Not applicable. There is no AI model or training set described in this document.

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The MantaRay Reperfusion Catheters, with the Imperative Care Aspiration Tubing Set and Imperative Care Aspiration Pump (or equivalent vacuum pump), 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.

The Imperative Care Aspiration Tubing Set is intended to connect the Imperative Care Reperfusion Catheter to the canister of the Imperative Care Aspiration Pump and to allow the user to control the fluid flow.

The MantaRay Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source generated from the Imperative Care Aspiration Pump using the Imperative Care Aspiration Tubing. The MantaRay Reperfusion Catheter will be offered with various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.

The MantaRay Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the MantaRay Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The MantaRay Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

This document describes the premarket notification (510(k) summary) for the MantaRay Reperfusion Catheters and Imperative Care Aspiration Tubing Set. The study primarily relies on a "substantial equivalence" argument by comparing the subject device to a predicate device (Penumbra System Reperfusion Catheter) through various bench, lab, and animal tests, rather than a standalone clinical study demonstrating a specific clinical outcome or a multi-reader, multi-case study for human-AI improvement.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comprehensive table (Table 4) detailing various test attributes and their corresponding specifications, which serve as acceptance criteria. The "Results" column in this context indicates that all tests passed or met these specifications, demonstrating the device's performance.

Biocompatibility Test Summary (Table 5)

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

• Test Set Description: The document focuses on bench, lab (in-vitro), and animal testing for substantial equivalence. There isn't a "test set" in the traditional clinical trial sense with human patient data.
• Sample Size:
  • Bench and Lab Testing: The largest and smallest diameter catheter sizes for both the subject and predicate devices were tested for the various performance attributes. The exact number of units per test is not specified, but the testing was conducted per "company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1."
  • Animal Studies: Performed in a porcine model. The number of animals used is not specified directly for the main animal study, but the thrombogenicity test was "Performed in duplicate."
  • Biocompatibility Testing: Guinea pigs and rabbits were used for sensitization and irritation tests, respectively. Mice were used for acute systemic injection tests. The number of animals per test is not explicitly stated in the summary table.
  • Physician Validation Study: Active US physicians experienced in interventional neuroradiology and neurovascular surgery were recruited. The number of physicians is not specified.
• Data Provenance: Not explicitly stated as country of origin of the data. All studies were conducted to support a US FDA 510(k) submission, implying they meet US regulatory standards. The animal and lab tests are pre-clinical. The physician validation study involved "US physicians." The nature of these studies is prospective as they were designed specifically to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Bench and Lab Testing: The "ground truth" for these tests are the defined engineering specifications (acceptance criteria) and physical measurements. These are established by engineering standards (e.g., ISO 10555-1) and internal company protocols. No external "experts" in the sense of clinical specialists are mentioned for establishing ground truth for these quantifiable measures.
• Animal Studies: The evaluation of vascular response and pathological findings was "histologically comparable" to the predicate device. This implies assessment by experts (likely veterinary pathologists), but their number and specific qualifications are not detailed.
• Physician Validation Study: "Active US physicians experienced in interventional neuroradiology and neurovascular surgery" participated. They performed clot retrieval procedures, and their performance/feedback constituted the evaluation. Their number and years of experience are not specified.

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

• There is no mention of an adjudication method in the context of expert consensus or dispute resolution for a "test set" of clinical cases. The various performance tests are against defined specifications or compared to a predicate device in controlled environments.
• For the physician validation study, the "results... were analyzed and compared," implying a statistical comparison rather than an expert adjudication process for ground truth.

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

• No MRMC comparative effectiveness study was done in the context of AI assistance. This document describes a medical device (catheter and aspiration system), not an AI device for diagnostic imaging or interpretation.
• The Physician Validation Study (Section L) involved physicians performing procedures with both the subject and predicate devices, demonstrating usability and comparable performance, but it was not a comparative effectiveness study designed to measure the improvement of human readers with AI assistance. It was a usability/performance study for a physical medical device.

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

• This question is not applicable. The device described, the MantaRay Reperfusion Catheter and Aspiration Tubing Set, is a physical medical device (catheter system) for mechanical thrombectomy, not an algorithm, AI, or software-only device. Its performance is inherently tied to human use (human-in-the-loop) and the mechanical action of aspiration.

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

• Bench and Lab Testing: Engineering specifications, physical measurements, and performance against industry standards (e.g., ISO 10555-1).
• Animal Studies: Histological analysis of vascular response and pathological findings; direct observation of successful revascularization, absence of perforation, dissection, or thrombosis. Comparison to the predicate device served as the control.
• Biocompatibility Testing: Standardized biological test methods (e.g., ISO 10993-x series) with defined pass/fail criteria.
• Physician Validation Study: Direct observation of procedural success in a simulated model (clot retrieval), and comparison of performance metrics between the subject and predicate devices.

8. The sample size for the training set

• This question is not applicable as the studies described are for regulatory clearance of a physical medical device. There is no mention of machine learning or an "AI" component requiring a training set in the document.

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

• This question is not applicable, as there is no "training set" for an AI or machine learning model in this submission.

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The EagleRay Long Sheath and EagleRay Access Catheter are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The EagleRay Long Sheath and EagleRay Access Catheter, hereinafter referred to as EagleRay Catheters, are 0.014"-0.038" guidewire compatible single lumen catheters that provide access to peripheral, coronary and neuro vasculature which allows insertion of other interventional devices.

The catheters are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. Additionally, an angled distal tip facilitates smoother tracking past vessel branches. The distal tip also has a radiopaque marker to provide the user with clear visual confirmation of the distal tip location under fluoroscopy.

The EagleRay Catheters will be offered with various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.

All EagleRay Catheters are packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

The 0.088" ID EagleRay Long Sheath is packaged with an additional accessory, a short, retractable Catheter Introducer. This accessory is intended to prevent damage to the EagleRay Long Sheath when advancing it through the hemostasis valve on the access site introducer sheath.

In addition to the supplied accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the EagleRay Catheters. All of these accessories are also commonly used with the predicate devices.

• Guidewires
• Support/Diagnostic Catheters
• Introducer Sheaths

The provided text is a 510(k) premarket notification summary for a medical device (EagleRay Long Sheath and EagleRay Access Catheter). It describes the device, its intended use, comparison to predicate devices, and various performance tests to demonstrate substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally phrased as specifications that the device shall meet or be comparable to competitive/predicate devices. The reported performance is summarized as "Pass" for all tests, indicating the device met these criteria.

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

• Sample Size for Test Set: The document does not specify exact sample sizes (N numbers) for each individual bench or lab test. It states "Bench and Lab (in-vitro) testing were conducted" and "Comparative testing was also performed." For the animal study, it notes "A series of subacute and chronic animal studies were conducted" and "Performed in duplicate" (for Ovine Jugular Thrombogenicity). While the number of animals for the thrombogenicity test is stated as "performed in duplicate," the overall number of animals for the "series" of studies is not explicitly given.
• Data Provenance:
  • Country of Origin: Not specified. Standard testing guidelines (ISO, ASTM) are referenced, suggesting internationally recognized methods.
  • Retrospective or Prospective: The testing described (bench, lab, animal studies) is inherently prospective in nature, as it involves newly conducted studies to evaluate the new device against defined criteria and predicate devices.

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

This document describes pre-market testing for a medical device (catheters), not an AI/software device that requires human expert review for "ground truth" to determine performance characteristics (like sensitivity/specificity for disease detection).

For the animal studies, it states: "Use of the test devices resulted in no significant vascular response during these studies and was found to be comparable to the control devices by the study pathologist and the study director." This indicates at least two experts were involved in interpreting the results of the animal studies. Their specific qualifications (e.g., years of experience) are not detailed beyond "study pathologist" and "study director."

4. Adjudication Method for the Test Set

Not applicable in the context of device performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for AI ground truth establishment where human readers might disagree on findings. Here, the "ground truth" is based on the physical properties of the device and biological responses in animal models, evaluated through standardized tests and expert interpretation.

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

No. This type of study (MRMC) is relevant for evaluating the impact of an AI system on human reader performance (e.g., radiologists interpreting images). This document describes the performance of a physical medical device (catheter) through bench, lab, and animal testing to demonstrate substantial equivalence to predicate devices, not an AI system.

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

No. This is not an AI device. The described tests are for the standalone performance of the physical catheter itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through a combination of:

• Engineering Specifications and Standards: Compliance with international standards (ISO, ASTM) and internal company protocols for various physical and mechanical properties (e.g., flow rate, burst pressure, bond strength, kink resistance).
• Biocompatibility Testing: In-vitro (cell culture) and in-vivo (animal) studies against established biological endpoints (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis, thrombogenicity).
• Comparative Performance to Predicate Devices: Performance attributes (e.g., dimensions, flexibility, lubricity, thrombogenic potential) were evaluated for "comparability" to legally marketed predicate devices, which serve as a benchmark for accepted safe and effective performance.
• Expert Interpretation: For the animal studies, pathologist and study director opinions contributed to the ground truth regarding biological response.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set." The testing described is verification and validation for a physical medical device.

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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