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Millipede70 Aspiration Catheter

The Millipede70 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is 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 thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

Perfuze Aspiration Tube Set

The Perfuze Aspiration Tube Set is indicated to connect the Millipede70 Aspiration Catheter to a compatible aspiration pump.

The Millipede70 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).

The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede70 Aspiration Catheter.

The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede70 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

For the aspiration source, the Millipede70 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

The provided FDA 510(k) clearance letter and summary for the Perfuze Ltd. Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set do not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers with and without AI assistance.

This submission focuses on demonstrating substantial equivalence of a physical medical device (catheter and aspiration tube set) to a previously cleared predicate device. The primary change is a minor modification to the outer diameter of the distal end of the catheter.

Therefore, many of the requested criteria regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for AI models are not applicable to this specific 510(k) submission.

However, I can still extract information about the acceptance criteria and the study that proves the physical device meets these criteria based on the provided document.

Acceptance Criteria and Device Performance for the Physical Device

The acceptance criteria for this physical device are primarily demonstrated through performance testing (bench testing), confirming its mechanical properties and functionality meet defined specifications and are comparable to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance:

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify exact sample sizes (N-values) for each bench test (e.g., how many catheters were subjected to kink resistance or torque strength testing). It broadly states "test specimen segments" or "test specimens."
• Data Provenance: The studies are bench (laboratory) tests conducted by the manufacturer, Perfuze Ltd., in Ireland. They are inherently prospective in the sense that they are designed and executed specifically for this regulatory submission. Country of origin of the data would be Ireland (where Perfuze Ltd. is based).

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

• Not Applicable. This is not an AI/ML device where expert consensus would establish ground truth for image interpretation or diagnosis. The "ground truth" for this physical device's performance is established by engineering specifications and physical measurements, and its functionality evaluated against predefined criteria in simulated environments.

4. Adjudication method for the test set:

• Not Applicable. As this is not a study involving human-in-the-loop assessment or expert review of clinical cases. Bench testing results are typically evaluated against pre-defined engineering 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 study was not conducted as this is a physical medical device (catheter) and not an AI/ML diagnostic or assistive software.

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

• Not Applicable. This is a physical device, not a standalone algorithm.

7. The type of ground truth used:

• For the physical device, the "ground truth" is defined by engineering specifications, performance standards, and functional demonstration in controlled laboratory environments (e.g., neurovascular models). The goal is to demonstrate that the device performs according to its design, is safe, and is substantially equivalent to a previously cleared device.

8. The sample size for the training set:

• Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.

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

• Not Applicable. There is no training set. The device's design and manufacturing are based on established engineering principles and material science, verified through the bench testing described.

Summary of the Device and Study:

The Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set are physical devices indicated for the revascularization of patients with acute ischemic stroke. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device (Millipede 070 Aspiration Catheter; K250012) due to a minor change in the distal outer diameter (from 0.0835" to 0.0837").

The study to prove the device meets acceptance criteria was non-clinical bench (laboratory) testing. This testing confirmed that the slightly modified device still met all relevant engineering specifications for dimensions, simulated use performance, coating integrity, kink resistance, tip stiffness, and torque strength. No new biocompatibility, sterilization, shelf-life, animal, or clinical studies were deemed necessary because the materials, fundamental design, indications for use, and operating principle remained the same as the predicate device. The change was determined not to raise different questions of safety or effectiveness.

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Millipede 070 Aspiration Catheter

The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is 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 thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

Perfuze Aspiration Tube Set

The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).

The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter.

The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

This document is a 510(k) summary for the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set. It states that the subject device is substantially equivalent to a previously cleared predicate device (K242504), also from Perfuze Ltd.

The key takeaway is that no new acceptance criteria, new studies, or performance data were generated or provided for this 510(k) submission (K250012) to prove the device meets acceptance criteria.

The reasoning presented in the document is that the subject device has identical indications for use, operating principle, and design to the predicate device. The only noted difference for the subject device (K250012) compared to the predicate device (K242504) is a different sterilization cycle for the Perfuze Aspiration Tube Set.

Therefore, the document argues that:

• Non-clinical bench testing was not required because "There are no changes to technological characteristics."
• Biocompatibility testing was not required because "The materials, formulation, and suppliers... are identical in the subject and predicate devices."
• Sterilization validation was performed only for the new sterilization cycle of the Perfuze Aspiration Tube Set to ensure it meets ISO 11135 standards, not to establish new performance criteria for the device itself.
• Shelf life and packaging testing was done to ensure the integrity of the sterile barrier with the new sterilization cycle, not to prove new performance.
• No animal or clinical studies were deemed necessary because of the substantial equivalence to the predicate device.

In summary, the document asserts substantial equivalence based on the device being functionally identical to an already cleared device, with only a change in a manufacturing process (sterilization of one component) that was validated to ensure it does not negatively impact existing performance.

Therefore, I cannot provide the requested information about acceptance criteria or specific study results for this 510(k) submission (K250012) because the document explicitly states that such studies were not performed for this submission due to perceived substantial equivalence.

The information requested, such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, and ground truth establishment, would have been part of the original K242504 submission that established the predicate device's safety and effectiveness. This current 510(k) (K250012) relies on the previous clearance rather than generating new performance data.

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The Zipline Access Catheter is indicated to facilitate the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

The Zipline Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using standard endovascular techniques. It is supplied sterile and nonpyrogenic. It is available in two sizes: Zipline 070. Zipline 070. Zipline 088 is designed for use with outer catheters with 0.088" or larger internal diameter, and Zipline 070 is designed for use with outer catheters with 0.070" or larger internal diameter.

During use, the Zipline Access Catheter is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is then advanced over the Zipline Access Catheter to the desired location.

The Zipline Access Catheter is a single lumen, variable stiffness catheter. It has a tapered flexible tip and a radiopague marker at its distal end. Proximal to the tapered section is a "bulb" and a radiopaque coil to facilitate bulb visualization under fluoroscopy. The outer of the bulb is designed to closely match the inner diameter of outer catheters, thereby minimizing the gap between the two catheters during navigation.

The Zipline Access Catheter has a hydrophilic coating on the outer surface of the distal end to enhance tracking through the vasculature. A luer fitting located on the catheter hub is used for attachment of ancillary devices. A continuous internal lumen spanning from the distal tip to the proximal hub accommodates guidewires up to 0.018" in diameter.

This document is a 510(k) Summary for a medical device called the "Zipline Access Catheter." It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, it does not describe a study proving a device meets acceptance criteria for an AI/ML product, nor does it contain information about expert ground truth, adjudication methods, MRMC studies, or training data.

The document details the device's technical specifications, its comparison to a predicate device, and the non-clinical testing performed to establish its safety and effectiveness.

Here's why the requested information cannot be extracted from this document:

• This is a 510(k) for a physical medical device (catheter), not an AI/ML-driven diagnostic or therapeutic device. The acceptance criteria and testing described relate to the physical and functional performance of the catheter (e.g., buckling force, torque strength, biocompatibility, kink resistance, radiopacity), not to the performance of an algorithm.
• The document explicitly states "no clinical study was conducted" because "The non-clinical performance testing was determined to be sufficient to support the substantial equivalence of the subject device to the predicate." This means there was no human-in-the-loop or standalone performance evaluation against a clinical ground truth, which would be typical for AI/ML devices.

To directly answer your request based on the provided text, but with the understanding that the product is a physical medical device:

1. A table of acceptance criteria and the reported device performance:
   The document presents several tables summarizing testing. I will consolidate the "Test" and "Conclusions" columns from the "Performance Testing - Bench" section as they effectively serve as acceptance criteria (the test performed) and reported performance (the conclusion, e.g., "met established specifications" or "suitable for its intended use").

   Acceptance Criteria (Test)	Reported Device Performance (Conclusions)
   Visual Inspection	The device surface characteristics are suitable for its intended use.
   Dimensional Inspection	The device met established specifications.
   Buckling Force Test	The device met established specifications.
   Simulated Use Testing	The device performs as intended under simulated use conditions.
   Torque Strength	The device met established specifications.
   Torque to Failure	Resistance to torque failure was similar to control devices.
   Hydrophilic Coating Integrity	The hydrophilic coating integrity is suitable for its intended use.
   Tensile Strength	The device met established specifications.
   Air Leakage (per ISO 10555-1:2013 Annex D)	The device integrity is suitable for its intended use.
   Liquid Leakage (per ISO 10555-1:2013 Annex C)	The device integrity is suitable for its intended use.
   Luer Dimensions and Performance (per ISO	The device met established specifications.
   80369-7:2021 and ISO 80369-20:2015)
   Kink Resistance	The device met established specifications.
   Radiopacity	The radiopacity was similar to a control device.
   Particulate Recovery	The particulate generation was similar to control devices.
   Biocompatibility: Cytotoxicity	The test article is non-cytotoxic.
   Biocompatibility: Sensitization	The test article did not elicit a sensitization response.
   Biocompatibility: Irritation	Requirements of the ISO intracutaneous reactivity test were met for the test article.
   Biocompatibility: Acute Systemic Toxicity	Requirements of the ISO acute systemic injection test were met for the test article.
   Biocompatibility: Material-Mediated Pyrogenicity	The test article is non-pyrogenic.
   Biocompatibility: Hemocompatibility (SC5b-9)	The test article is not considered to be a potential activator of the complement system.
   Biocompatibility: Hemocompatibility (PTT)	The test article is not considered to be an activator of the intrinsic coagulation pathway.
   Biocompatibility: Hemocompatibility (Hemolysis)	The test article is considered non-hemolytic.
   Biocompatibility: Hemocompatibility (Thromboresistance)	The test articles have similar thromboresistance characteristics as the control devices.
   Animal Testing (In vivo performance & safety)	Demonstrated acceptable results; histologic evaluations concluded comparable tissue response to control device.
   Sterilization (Ethylene Oxide)	Validated using the overkill method according to ISO-11135, achieved 1x10-6 sterility assurance level.
   Shelf Life and Packaging	12-month shelf life verified by accelerated aging (ASTM F1980) and functional/performance testing on aged devices.

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

   • Bench Testing: The document does not specify exact sample sizes for each bench test, but implies that "test specimens" and "catheters" were used. It signifies that multiple samples were tested to demonstrate conformity to specifications.
   • Animal Testing: "Suitably sized branches of the carotid arteries in a porcine model." The number of animals or specific vessels tested is not provided, but it was "in comparison to a control device."
   • Data Provenance: The testing was conducted internally by Perfuze Ltd. (Ireland) or by their contractors, as typically expected for device manufacturers. It is non-clinical laboratory data.

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 is not an AI/ML device requiring human expert label ground truth. The "ground truth" for the physical device performance is established by standardized test methods (e.g., ISO, ASTM) and engineering specifications. For the animal study, histological evaluation would have been performed by qualified pathologists, but specific numbers or qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This relates to consensus for human interpretation, not physical device testing.

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 for AI/ML devices, not a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is for AI/ML devices, not a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For physical and chemical attributes, the "ground truth" is defined by engineering specifications, validated test methods (e.g., ISO, ASTM), and established biocompatibility standards (e.g., ISO 10993). For the animal study, the ground truth was histological evaluations and angiographic assessments, which would typically be performed by veterinary pathologists and imaging specialists.

8. The sample size for the training set:
   Not applicable. There is no AI/ML algorithm or training set for this physical device.

9. How the ground truth for the training set was established:
   Not applicable. There is no AI/ML algorithm or training set for this physical device.

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Millipede 088 Access Catheter: The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

Millipede 070 Aspiration Catheter: The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is 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.

Perfuze Aspiration Tube Set: The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

Millipede 088 Access Catheter: The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set: The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a RHV. The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter. The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter. For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

This document describes the K242504 submission for the Perfuze Ltd. Millipede 088 Access Catheter, Millipede 070 Aspiration Catheter, and Perfuze Aspiration Tube Set. This is a 510(k) premarket notification for devices that are substantially equivalent to previously cleared predicate devices. The devices are catheters used in neurovascular procedures.

This submission focuses on a change in color additives used in the proximal shaft of the catheters and does not involve any AI/ML components. Therefore, many of the requested categories related to AI/ML performance, such as human reader improvement with AI assistance, standalone algorithm performance, training/test set sizes, expert qualifications, and ground truth establishment for AI/ML, are not applicable in this context.

Here's a breakdown of the relevant information provided in the document:

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

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

• Not applicable in the context of an AI/ML test set. The testing performed was for device biocompatibility and mechanical performance, not for an AI/ML algorithm. The specific number of devices tested for each biocompatibility and performance test is not detailed in this summary. The data provenance would be from laboratory testing conducted according to ISO and ASTM standards.

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

• Not applicable. This submission focuses on the safety and effectiveness of a physical medical device (catheter) with a material change, not an AI/ML algorithm requiring expert-established ground truth. Expert involvement would be in the design, execution, and interpretation of the physical and chemical tests, typically by qualified laboratory personnel and engineers, rather than clinical experts establishing "ground truth" for a diagnostic reading.

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

• Not applicable. This is relevant for studies involving human interpretation or AI/ML output requiring consensus, not for the direct physical and biological testing of a catheter.

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 was not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• No. This was not an AI/ML device. Therefore, no standalone algorithm performance was assessed.

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

• Not applicable in the AI/ML sense. For this submission, the "ground truth" for the device's properties are established by rigorous testing against pre-defined engineering specifications and biocompatibility standards (e.g., ISO 10993-1). For example, the "ground truth" for tensile strength is whether test samples break below a specified force, and for cytotoxicity, it's whether cell viability meets a threshold.

8. The sample size for the training set:

• Not applicable. This submission is for a physical medical device, not an AI/ML algorithm that requires a training set.

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

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

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The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).

The Millipede 088 Access Catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Millipede 088 Access Catheter." It is a submission for a new version of an existing device (K231802). The document focuses on demonstrating that the new subject device (K233648) is "substantially equivalent" to this predicate device. This means the primary goal is to show the new device is as safe and effective as the previously cleared one, not to prove its efficacy from scratch through a clinical trial.

Therefore, the requested information about device performance, particularly related to clinical acceptance criteria, expert ground truth, MRMC studies, standalone algorithm performance, and training/test sets, does not directly apply to this type of device submission. This document describes a physical medical device (catheter), not a software algorithm or an AI-powered diagnostic tool. The "performance testing" described refers to mechanical, material, and functional bench tests, not clinical performance metrics in the way one would evaluate an AI diagnostic tool.

The "acceptance criteria" for this device are met by demonstrating substantial equivalence to the predicate device through:

• Identical Indications for Use.
• Similar technological characteristics.
• Successful completion of non-clinical (bench) performance testing and biocompatibility testing.

Here's a breakdown of the closest applicable information from the provided text, while acknowledging that many of the original prompt's requests are not relevant to a physical catheter's 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are design specifications and regulatory standards for the physical and biological properties of the catheter. The "reported device performance" indicates whether the device met these specifications and standards.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each bench test (e.g., how many catheters were kink-tested or burst-tested). It refers to standard "test specimens" and "device dimensions."

Data Provenance: The testing was conducted by Perfuze Ltd., which is based in Ireland, suggesting the provenance of the bench test data is from their internal testing or accredited labs they contracted. The tests are "bench" tests, meaning they are performed in a lab setting, not on patient data.

Retrospective or Prospective: These are laboratory bench tests, so the concept of retrospective or prospective data collection doesn't apply as it would for clinical data.

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

This concept is irrelevant for a physical device's bench testing. Ground truth for these tests is established by objective physical measurements against engineering specifications (e.g., using calipers for dimensional inspection, pressure sensors for burst tests, standardized biological assays for biocompatibility).

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

Not applicable. Bench tests follow predefined protocols and objective measurements.

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 for a physical medical 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 for a physical medical device, not an AI diagnostic tool.

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

The "ground truth" for the bench tests is based on engineering specifications, industry standards (e.g., ISO, ASTM), and validated test methods. For biocompatibility, it's based on biological responses in standardized assays.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that undergoes "training."

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

Not applicable.

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The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is 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 Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV). The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter.

The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

The document you provided is a 510(k) premarket notification for a medical device (Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the detailed clinical study data often seen for novel devices that might require a PMA (Premarket Approval) or de novo classification.

Therefore, the information typically requested in your prompt (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, training set size for AI, etc.) is not present in this document because it is not a study assessing the performance of an AI/ML-driven device or an imaging diagnostic tool. Instead, this is a clearance for a physical medical catheter and tubing set.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biological performance testing, not AI/ML model validation.

Here's a breakdown based on the document, addressing what is present and explaining why other points are absent:

Device: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Regulatory Classification: Class II Percutaneous Catheter (Product Code: NRY)

Purpose of Submission: Demonstrate substantial equivalence to the SOFIA Plus Aspiration Catheter (K173200).

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance tests and their conclusions, acting as the "acceptance criteria" and "reported device performance." Since this is not an AI/ML device, the criteria are physical and functional, rather than diagnostic accuracy metrics.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of catheters tested for kink resistance). However, for the animal study, it mentions "two comparative animal studies conducted under Good Laboratory Practices in a porcine model." The exact number of animals is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated for bench testing, but Perfuze Ltd. is based in Galway, Ireland, suggesting testing likely occurred there or at contracted labs.
  • Retrospective/Prospective: All described tests and the animal study are prospective design, as they were specifically conducted to support this premarket notification.

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

• Not applicable for this type of device. This device is a physical catheter and tube set, not a diagnostic AI/ML system. There is no "ground truth" to be established by human experts in the context of image interpretation or disease diagnosis. The "ground truth" here is the physical measurement, functional performance (e.g., flow rate), or biological response (e.g., non-cytotoxic).

4. Adjudication Method for the Test Set

• Not applicable. As there are no human expert readers establishing a diagnostic "ground truth," there is no need for an adjudication method. The test results are objective measurements or observations during laboratory testing.

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 not an AI-assisted diagnostic device. Its function is direct mechanical aspiration. No MRMC study was conducted or is relevant.

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

• Not applicable. This is not an algorithm or software device. Its performance is evaluated through bench testing and animal studies as described.

7. The Type of Ground Truth Used:

• For Biocompatibility: Laboratory assays and histological/pathological evaluation (e.g., for pyrogenicity, cytotoxicity, systemic toxicity, sensitization, irritation, hemocompatibility in vitro/in vivo, and animal tissue analysis).
• For Performance Testing: Objective measurements (e.g., dimensions, flow rates, tensile strength), functional assessments (e.g., kink resistance, leakage), and simulated use observations against pre-defined engineering specifications.
• For Animal Study: Angiographic and histological evaluations of the porcine model.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve an AI/ML model that requires a training set.

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

• Not applicable. No training set for an AI/ML model is involved.

Summary regarding AI/ML related questions: The questions about experts, adjudication, MRMC studies, standalone algorithms, and training sets are relevant for submissions of Artificial Intelligence / Machine Learning (AI/ML) enabled diagnostic devices or software as a medical device (SaMD). The provided document is for a traditional, physical interventional device (catheter and tube set), and therefore, the testing described focuses on its physical, mechanical, and biological properties, as well as its functional similarity to predicate devices.

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The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).

The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

This document is a 510(k) Summary for a medical device called the Millipede 088 Access Catheter. It's a submission to the FDA for market clearance, asserting that the "subject device" (new version) is substantially equivalent to a "predicate device" (previously cleared version).

Here's the breakdown of acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document describes a medical device, not an AI/Software as a Medical Device (SaMD). Therefore, questions related to AI-specific metrics like human reader improvement with AI assistance, training sets, and expert qualifications for ground truth establishment for AI models are not applicable in this context. The "acceptance criteria" here refer to engineering and performance specifications for the physical catheter and its accessories.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct "acceptance criteria" column with specific numerical targets. Instead, it lists various performance tests and then states whether the device "met established specifications" or if the characteristics are "suitable for its intended use." I will infer the acceptance criteria from these conclusions.

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

The document does not explicitly state sample sizes for each test in the "Performance Testing (Bench)" section. For bench tests, it typically involves a certain number of devices tested to ensure reproducibility and statistical significance. However, this specific summary does not offer those details. The testing is bench-top testing, meaning it's performed in a laboratory setting, not on patient data. There is no 'data provenance' in terms of country of origin or retrospective/prospective for this type of physical device testing.

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

This question is not applicable. This is a physical medical device. "Ground truth" in the context of expert review is for evaluating the performance of diagnostic algorithms or imaging interpretations, which is not what this document is about. The "ground truth" for the device's performance is established by standardized engineering measurements and tests.

4. Adjudication Method for the Test Set

This question is not applicable. As stated above, this is about physical device performance, not interpretive tasks requiring expert 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

This question is not applicable. This is not an AI-assisted diagnostic device.

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

This question is not applicable. This is not an algorithm or software device.

7. The type of ground truth used

For the performance testing, the "ground truth" is derived from established engineering specifications, industry standards (e.g., ISO, ASTM), and simulated use conditions designed to mimic real-world scenarios. For biocompatibility, the ground truth is defined by the Pass/Fail criteria outlined in the relevant ISO 10993 standards.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This question is not applicable, as there is no training set for this type of device.

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The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).

The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

The provided document is a 510(k) summary for the Millipede 088 Access Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a standalone clinical study to prove the device meets those criteria.

Therefore, the document does not contain the information requested in points 2, 3, 4, 5, 8, and 9, and only partially addresses points 1, 6, and 7.

Here's a breakdown of what can be extracted:

1. Acceptance Criteria and Reported Device Performance

The document lists various performance tests and their conclusions, indicating that the device met "established specifications" or was "suitable for its intended use." However, the specific quantitative acceptance criteria for each test are not provided. The reported device performance is qualitative rather than quantitative in most cases.

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

The document does not specify the sample sizes for the individual performance tests beyond implicitly suggesting multiple samples were tested (e.g., "test specimens," "test articles"). For the Animal Testing, it states "two studies in a porcine model."

The data provenance for the in vitro and animal studies isn't explicitly stated beyond "Good Laboratory Practices" for the animal studies, which is a standard of conduct rather than a geographic origin. No human data is presented.

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)

This information is not provided as the submission relies on objective performance testing, biocompatibility studies, and animal studies rather than expert-derived ground truth from human data for this type of device.

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

Not applicable. The evaluation methods described are objective performance tests and animal studies, not human data requiring expert 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. This device is an access catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

Yes, the performance testing described (mechanical, dimensional, coating integrity, etc.) and the animal studies represent "standalone" evaluations of the device's physical and functional properties without human interpretation of data in a clinical context.

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

For the performance and biocompatibility tests, the "ground truth" is defined by the established specifications, relevant ISO standards, and comparison to control devices or predicate devices. For example:

• "The device met established specifications."
• "The test article is non-cytotoxic."
• "The particulate size and count were similar to control devices."
• "The radiopacity of the Millipede 088 Access Catheter was similar to a control device."
• For animal testing, "Usability, radiopacity, thromboresistance, and vessel injury were assessed," and "The results for the subject device were comparable to a control device."

8. The sample size for the training set

Not applicable. This device is a medical catheter and does not involve a "training set" in the context of machine learning or AI. Its performance is evaluated through engineering and biological testing.

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

Not applicable (as above).

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