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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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Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators 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 therapy are candidates for treatment.

Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device 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) 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.

Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump

The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System® is comprised of the following devices:

• Penumbra Reperfusion Catheter
• Penumbra Aspiration Pump
• Penumbra Aspiration Pump/Canister Tubing
• Penumbra Aspiration Tubing
• Penumbra Separator
• Penumbra 3D Revascularization Device

The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an ID of 0.054 in. or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.

This document describes the acceptance criteria and study proving the performance of the Penumbra System® (Reperfusion Catheter RED™ 72). It is a 510(k) summary, indicating that the device is being cleared based on substantial equivalence to a legally marketed predicate device, rather than requiring a full premarket approval (PMA) with extensive clinical trials.

It's important to note that because this is a 510(k) submission based on substantial equivalence to an existing device (the Penumbra System (Reperfusion Catheter JET 7)), the studies primarily focus on engineering and biocompatibility performance data against established requirements, rather than clinical efficacy studies often seen with novel AI devices. There are no AI/ML components described in this document, thus the requested information regarding MRMC studies, standalone AI performance, human expert ground truth for imaging, and training/test set sample sizes for AI models are not applicable.

Here's the breakdown of the acceptance criteria and study details provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a series of design verification tests and biocompatibility tests. The acceptance criteria for each test are stated, and the conclusion is consistently that the "Acceptance Criteria Met" or "Pass."

Design Verification Testing:

Biocompatibility Testing (Based on predicate/reference devices):

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

The document does not specify the exact sample sizes (number of units) used for each design verification bench test, as is typical for 510(k) summaries of mechanical devices. However, it indicates that units were tested. The data provenance would be from internal testing conducted by Penumbra, Inc. (the manufacturer). This is a retrospective evaluation of the device's physical and functional properties. There is no indication of country of origin for specific test data beyond the manufacturer being in Alameda, California, USA.

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

Not applicable. This submission is for a mechanical medical device (catheter system), not an AI/ML device that requires human expert annotation for ground truth in image analysis. The "ground truth" for this device's performance is established by objective physical and chemical testing against engineering specifications and international standards (e.g., ISO, USP).

4. Adjudication Method for the Test Set

Not applicable. As there are no human expert readings or interpretations involved in the performance data presented (it's benchmark and material testing), there is no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a mechanical catheter system for stroke intervention, not an AI/ML diagnostic tool. Therefore, no such study was performed or required.

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

No. This refers to the standalone performance of an AI algorithm. Since this is a mechanical device, this concept is not applicable. The standalone "performance" refers to the device meeting its physical and functional specifications during bench testing.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance evaluation comes from engineering specifications, international standards (e.g., ISO 10993 series), and validated test methods. This includes:

• Pre-defined dimensional and visual product specifications.
• Measured physical properties (friction, tensile strength, pressure, elongation, torque, burst pressure).
• Chemical and biological properties (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) determined through laboratory assays adhering to GLP (Good Laboratory Practices) and ISO standards.
• Functionality in simulated clinical use benchtop models.

8. The Sample Size for the Training Set

Not applicable. This refers to a training set for an AI model. This device is a mechanical medical device, not an AI/ML product.

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

Not applicable. As there is no AI training set, there is no ground truth establishment for it. The "ground truth" for the device's design and manufacturing is based on established engineering principles, materials science, and medical device regulations.

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Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators 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 therapy are candidates for treatment.

Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device 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) 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.

Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump

The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System® is comprised of the following devices:

• . Penumbra Reperfusion Catheter
• Penumbra Aspiration Pump .
• Penumbra Aspiration Pump/Canister Tubing .
• Penumbra Aspiration Tubing ●
• . Penumbra Separator
• Penumbra 3D Revascularization Device .

The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an ID of 0.054 in. or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Penumbra System (RED 68 Reperfusion Catheter):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Design Verification Testing: The document does not specify a quantitative sample size for each individual design verification test. It states "the units" were tested.
• Biocompatibility Testing: The sample sizes for animal tests (e.g., systemic toxicity, irritation, sensitization) are not explicitly stated in this document but are implied to be sufficient for GLP compliance.
• Data Provenance: Not explicitly stated for each test, but the tests were performed by Penumbra, Inc. as part of their 510(k) submission. For biocompatibility, it states "previous biocompatibility testing on the predicate and reference devices applies to the subject device" and "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)." This suggests a mix of historical data from predicate/reference devices and possibly new testing. The country of origin is not mentioned, but is likely the USA, given the FDA submission. All data appears to be retrospective in the sense that the studies were already completed for the submission.

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

There is no mention of "experts" being used to establish ground truth in the context of the design verification or biocompatibility testing described. These tests rely on predefined engineering specifications, standardized test methods (e.g., ISO standards), and laboratory procedures, rather than expert interpretation of a test set.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, measurable physical and biological tests against established criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance?

Not applicable. This device is a medical catheter and does not involve AI or human readers for diagnostic interpretation. The studies are for physical and biological performance of the device itself.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Design Verification Tests: The "ground truth" for these tests is based on engineering specifications and performance requirements defined for the device. For example, a catheter must not kink at a certain radius, or it must withstand a certain pressure.
• Biocompatibility Tests: The "ground truth" is based on established biological safety standards and criteria (e.g., ISO 10993 guidelines, USP requirements). These standards define what constitutes non-cytotoxic, non-sensitizing, non-irritating, etc.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable. There is no training set mentioned or implied.

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