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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 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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