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INDIGO Aspiration Catheters and Separators:

As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

INDIGO Aspiration Tubing:

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

Penumbra Aspiration Pump:

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

The INDIGO® Aspiration System is comprised of the several devices:

• INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Aspiration Pump Canister
• INDIGO Aspiration Tubing
• INDIGO Separator

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

The provided text is a compilation of FDA documents related to the 510(k) clearance for the Penumbra, Inc. Indigo® Aspiration System – Lightning® Flash. It describes the device, its indications for use, and a comparison to predicate devices, along with summaries of non-clinical data (biocompatibility and bench-top testing).

Based on the information provided, here's an analysis regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a quantitative manner as one might expect for an AI/ML device. Instead, it describes general compliance and qualitative outcomes for various tests.

The reported performance is described in a narrative format, indicating that tests "met all acceptance criteria" and "performed similarly to the predicate devices."

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

The document does not provide details on the specific sample sizes used for each non-clinical (bench-top) test or biocompatibility test. It mentions "testing was conducted" and "tests were performed" without quantifying the number of units or replicates involved.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable as the studies described are non-clinical bench-top tests and biocompatibility assessments, not clinical studies involving patient data.

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

This information is not applicable. The device is an embolectomy catheter system, which is a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert interpretation to establish ground truth for a test set. The "ground truth" for its performance is established through measurable physical and biological parameters in laboratory settings (e.g., tensile strength, aspiration efficacy in simulated models, biocompatibility of materials).

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

This information is not applicable for the reasons stated in point 3. The studies are technical verification and validation, not studies requiring adjudication of image interpretations or clinical outcomes by multiple experts.

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 type of study is relevant for AI/ML-driven diagnostic tools, not for a mechanical medical device like an aspiration system. The document explicitly states: "No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes."

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

No. This concept is not applicable as the Indigo® Aspiration System – Lightning® Flash is a mechanical medical device, not an algorithm or AI system.

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

The "ground truth" for this device's performance is based on well-established engineering standards, material science principles, and biological safety assessments. This includes:

• Quantitative measurements from bench-top tests (e.g., dimensions, tensile strength, vacuum pressure).
• Adherence to recognized standards (e.g., ISO, ASTM for materials and performance, IEC for electrical safety).
• Biocompatibility testing results (e.g., lack of cytotoxicity, sensitization).
• Functional performance in simulated use models (e.g., removal of simulated thrombi).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML product that undergoes a "training set" for model development. The development process involves engineering design, prototyping, and testing of physical units.

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

Not applicable, as there is no "training set" in the context of this mechanical medical device.

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The INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The INDIGO Aspiration Tubing As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The INDIGO Aspiration System is comprised of several devices: - INDIGO CAT RX Aspiration Catheter . - INDIGO Separator 4 ● - . INDIGO Aspiration Tubing - . INDIGO Pump Canister/Tubing - . Penumbra Aspiration Pump The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The INDIGO CAT RX Aspiration Catheter is a dual lumen rapid exchange catheter that targets aspiration from the Pump directly to the thrombus, removing it via the INDIGO Aspiration Tubing and depositing it in the Pump Canister. The INDIGO Separator 4 may be used, if needed, to clear the lumen of the INDIGO CAT RX Aspiration Catheter should it become blocked with thrombus. The INDIGO CAT RX Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO CAT RX Aspiration Catheter may be provided with a rotating hemostasis valve and a peelable sheath. The INDIGO Separator 4 is provided with an introducer and torque device. The INDIGO CAT RX Aspiration Catheter and INDIGO Separator 4 are visible under fluoroscopy.

The provided text is a 510(k) summary for the Penumbra INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4). It is a submission to the FDA for market clearance, asserting substantial equivalence to a previously cleared predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/ML perspective. The device in question is a medical aspiration system, not an AI/ML diagnostic or therapeutic device.

The "Performance Data - Non-Clinical" and "Performance Data - Clinical" sections explicitly state:

• "The subject and predicate Indigo System (CAT RX Aspiration Catheter and Separator 4) devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged." (Section 1.10)
• "No clinical study was conducted as previously performed bench and animal testing was determined sufficient for verification and validation purposes for substantial equivalence determination." (Section 1.16)

The submission leverages prior testing and clearance of an identical predicate device. Therefore, there are no new studies or acceptance criteria specifically for this 510(k) submission to describe. The original predicate device (K180412 and reference K163618) would have had its own performance data and acceptance criteria, but those are not detailed in this document.

Therefore, it is not possible to answer the requested questions based on the provided text. The text does not describe an AI/ML device, nor does it present new performance data or acceptance criteria for a study demonstrating adherence to such criteria. The entire premise of the 510(k) is that the device is identical to a predicate and thus no new performance testing is required for this submission.

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INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

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

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

The INDIGO® Aspiration System is comprised of the several devices:

• · INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• · INDIGO Aspiration Pump Canister
• · INDIGO Aspiration Tubing
• · INDIGO Separator™

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

Lightning Aspiration Tubing: The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration. Intended users for this device are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is provided sterile, non-pyrogenic, and intended for single use only.

This document is a 510(k) premarket notification for the Penumbra, Inc. Indigo® Aspiration System - Lightning™ Aspiration Tubing (K210323). It claims substantial equivalence to a predicate device (K193244).

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the subject device "met all specifications and testing requirements under the previously established test methods" for the predicate device. However, it does not provide a specific table of quantitative acceptance criteria or detailed reported device performance values. Instead, it makes general statements about meeting requirements.

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

The document mentions "Bench-top performance (design verification)" and "Electrical Safety and Suction Equipment Testing." However, it does not specify the sample sizes used for these tests. The data provenance is also not explicitly stated in terms of country of origin or whether it's retrospective/prospective, but the nature of the testing (bench-top, electrical safety) implies internal laboratory testing, which is typically prospective for verification.

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

This information is not applicable and not provided. The testing described relates to the physical and electrical properties of medical device components, not diagnostic accuracy or clinical outcomes that would require expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As with point 3, adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for bench-top or electrical safety testing of device components.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, and the subject device (Lightning Aspiration Tubing) is a physical component, not an AI or imaging diagnostic tool.

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 is not an AI-powered device. The testing described focuses on the physical and electrical performance of the aspiration tubing.

7. The Type of Ground Truth Used:

For the bench-top performance and electrical safety testing, the "ground truth" would be the established engineering specifications and regulatory standards (e.g., IEC 60601 series). The device's performance was compared against these predefined requirements.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable and not provided. As mentioned, there is no training set for this type of device.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence of a medical device component (aspiration tubing) through bench-top and electrical safety testing. The criteria for acceptance are compliance with established engineering specifications and regulatory standards. The document asserts that these criteria were met but does not provide the granular data or specific acceptance thresholds that would be found in a detailed test report. It is not an AI-enabled device, and therefore many of the requested data points (like expert ground truth, MRMC studies, training sets) are not relevant to this submission.

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INDIGO Aspiration Catheters and Separators:

As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

INDIGO Aspiration Tubing:

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

Penumbra Aspiration Pump:

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

The INDIGO® Aspiration System is comprised of:

• INDIGO Aspiration Catheter .
• Penumbra Aspiration Pump .
• INDIGO Aspiration Pump Canister ●
• INDIGO Aspiration Tubing ●
• INDIGO Separator™ .

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

This FDA 510(k) Premarket Notification is for the Indigo Aspiration System - Aspiration Catheter 12 and Separator 12. The document states that the subject device is identical to the predicate device (K192981) and leverages clinical data from a reference device (K192833). Therefore, the information below focuses on the clinical study (EXTRACT-PE) mentioned as supporting the substantial equivalence for the subject device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the subject device. Instead, it states that the EXTRACT-PE trial (for the reference device K192833) "demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met."

• Acceptance Criteria (Implied from the statement): Meeting primary efficacy and safety endpoints for acute Pulmonary Embolism (PE) treatment, demonstrating substantial equivalence to existing treatments. Specific numerical acceptance criteria are not provided in this document.
• Reported Device Performance: Achieved substantially equivalent safety and effectiveness outcomes for acute PE, and met primary efficacy and safety endpoints.

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

The document refers to the EXTRACT-PE clinical study for the reference device (K192833). However, it does not provide the specific sample size used for this trial nor the data provenance (country of origin, retrospective/prospective) within this 510(k) summary. Further documentation would be needed to extract this detail.

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

This information is not provided in the given document. The summary only mentions "primary efficacy and safety endpoints were met," implying clinical assessment, but not the specifics of ground truth establishment by experts.

4. Adjudication Method for the Test Set:

This information is not provided in the given document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device described is an aspiration system (a medical device used for removing emboli and thrombi), not an AI-based diagnostic or imaging device that would involve human readers interpreting output with or without AI assistance.

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

This is not applicable. The device is a physical medical device, not an algorithm. Performance is assessed through its use in a clinical setting by medical professionals.

7. The Type of Ground Truth Used:

For the EXTRACT-PE study, the ground truth would have been established through clinical outcomes data related to the efficacy (e.g., successful removal of thrombi, resolution of PE symptoms, improvements in relevant physiological parameters) and safety (e.g., adverse events, complications) of the device in treating acute PE.

8. The Sample Size for the Training Set:

This information is not provided in the given document. As it is a non-AI medical device, the concept of a "training set" in the context of machine learning does not directly apply. The clinical study for the reference device would have involved a patient cohort, but the specific number is not stated.

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

As above, the concept of a "training set" is not directly applicable. For the clinical study that demonstrated the device's performance, the "ground truth" (clinical outcomes, safety events, etc.) would have been established through standard clinical trial methodologies, including objective measurements, physician assessments, and follow-up data collection on patients enrolled in the trial.

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INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.

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

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

The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, nonpyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional techniques.

The INDIGO® Aspiration System is comprised of several devices:

• . INDIGO Aspiration Catheter
• Penumbra Aspiration Pump ●
• INDIGO Aspiration Pump Canister .
• INDIGO Aspiration Tubing ●
• . INDIGO Separator™

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

The Penumbra, Inc. Indigo Aspiration System, specifically the Aspiration Catheter 7 and Separator 7, underwent various non-clinical tests to demonstrate its substantial equivalence to predicate devices. The following information summarizes the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each individual test within the "Design Verification (Bench-top Testing)" section. It generally states that "units used in this Design Verification testing" were evaluated. The data provenance is not explicitly stated as country of origin, but it is implied to be from Penumbra, Inc. in Alameda, CA, USA, where the device manufacturer is located. The studies are non-clinical (bench-top and laboratory testing), not human or animal studies, so the terms "retrospective" or "prospective" are not directly applicable in the same way they would be for clinical 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):

This information is not applicable. The studies described are non-clinical engineering and laboratory tests (biocompatibility, mechanical performance, etc.). Ground truth in this context refers to established engineering specifications and international standards, not expert medical opinion on diagnostic images or patient outcomes.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies where multiple human readers are involved. The studies described here are objective, quantifiable engineering and laboratory tests with predetermined 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:

This information is not applicable. The device described (Indigo Aspiration System - Aspiration Catheter 7 and Separator 7) is a physical medical device (catheter and separator for thrombus removal), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable. As stated above, the device is a physical medical device, not an algorithm or AI.

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

The "ground truth" for the non-clinical tests was based on pre-determined product specifications, engineering standards, and international regulations/guidelines. For example:

• Biocompatibility: ISO 10993-1, USP standards, FDA GLP, BS EN ISO 10993-4.
• Mechanical and Physical Properties: Specific maximum/minimum values, visual criteria (e.g., "no air leaks," "no visible corrosion," "must be Diamond shape"), and adherence to accepted test methods.
• Sterilization: BS EN ISO 11135.
• Shelf Life & Packaging: Acceptance criteria established for stability and integrity.

8. The sample size for the training set:

This information is not applicable. There is no mention of an algorithm or AI model requiring a training set. The device is a physical medical instrument.

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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INDIGO Aspiration Catheters and Separators:

As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

INDIGO Aspiration Tubing:

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

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

The INDIGO® Aspiration System is comprised of several devices:

• INDIGO Aspiration Catheter ●
• Penumbra Aspiration Pump ●
• INDIGO Aspiration Pump Canister
• INDIGO Aspiration Tubing ●
• . INDIGO SeparatorTM

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

This document outlines the substantial equivalence of the "Indigo Aspiration System Lightning Aspiration Tubing" (subject device) to a predicate device (K193244) and a reference device (K192833). The review primarily focuses on demonstrating that the subject device is identical to the predicate device and that prior performance data for similar devices within the Indigo Aspiration System remain applicable.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The subject and predicate Indigo System devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged." This implies that the acceptance criteria for the subject device are met by virtue of it being identical to a previously cleared predicate device that had already satisfied those criteria.

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

• Biocompatibility & Bench-Top Performance: Not explicitly stated for the subject device, as these tests were not re-performed. The document refers to data from the predicate device (K193244). The specific sample sizes and provenance for those original tests are not detailed in this document.
• Clinical Performance (EXTRACT-PE Trial): The sample size for the clinical study (EXTRACT-PE) is not specified in this document. The data provenance is also not specified (e.g., country of origin). It is stated as a "clinical study" and "trial," suggesting it was prospective. The document refers to the data from the reference device (K192833).

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

This information is not available in the provided document. The document refers to previous clearances (K193244 and K192833) for performance data, but does not detail how ground truth was established for those studies.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

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

An MRMC study was not mentioned or implied. The clinical data cited (EXTRACT-PE) appears to focus on device efficacy and safety outcomes rather than reader performance with or without AI assistance.

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

This is not applicable. The device (Indigo Aspiration System Lightning Aspiration Tubing) is a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant here.

7. The Type of Ground Truth Used

For the clinical study (EXTRACT-PE) related to the reference device, the document states it "demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met." This implies that the ground truth was based on clinical outcomes data related to the efficacy of thrombus removal and patient safety in acute pulmonary embolism settings. Specific methods for establishing definitive "ground truth" for patient outcomes (e.g., imaging confirmation, pathology reports, adjudicated clinical events) are not detailed.

8. The Sample Size for the Training Set

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

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

This is not applicable. The device is a physical medical device, not an AI model.

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INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. The Indigo System was most recently cleared under K180939.
The INDIGO® Aspiration System is comprised of the several devices:

• · INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Pump/Canister Tubing
• INDIGO Aspiration Tubing
• INDIGO Separator
  The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
  Lightning Aspiration Tubing: The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration.

This document is a 510(k) Pre-market Notification for a medical device (Indigo Aspiration System - Lightning Aspiration Tubing) and as such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a comparative effectiveness study with human readers assisting AI or an AI standalone system. The concepts of AI assistance, multi-reader multi-case studies, and specific performance metrics like sensitivity/specificity for AI are not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance testing conducted to ensure the new device functions as intended and is equivalent to the predicate device. The prompt's request for information largely aligns with the type of evaluation performed for an AI-powered diagnostic device, which is not what this document describes.

Therefore, providing a direct answer to all points of the prompt as though the document describes an AI diagnostic or assistive device study would be factually incorrect and misleading.

However, I can extract the relevant information regarding the engineering/performance acceptance criteria and the supporting studies from the provided document as it pertains to the device's substantial equivalence.

Here's how the information can be broken down based on the document's content, focusing on what is present:

Device: Indigo Aspiration System - Lightning Aspiration Tubing

Regulatory Class: Class II

Product Code: QEW (Embolectomy Catheter)

Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K180939, 110 Aspiration Tubing, modified).

1. Table of Acceptance Criteria and Reported Device Performance

The document details various non-clinical tests performed to demonstrate the device meets its design specifications and is substantially equivalent to the predicate. These are more akin to engineering and material acceptance criteria rather than diagnostic performance metrics.

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

• Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an AI study. The "test sets" for each specific engineering/performance test (e.g., biocompatibility, tensile strength, simulated use) would vary, but the document does not provide the exact sample sizes for each. It generally states that "units" or "the subject device" were tested.
• Data Provenance: The tests are non-clinical (bench-top, laboratory testing) and focused on device performance, not clinical patient data. The provenance is internal to Penumbra, Inc. (Alameda, CA, USA). The document does not specify if any retrospective or prospective patient data was used, as it explicitly states "Clinical Testing was not required".

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

This concept is not applicable to this 510(k) submission. "Ground truth" in the context of AI diagnostic performance is typically established by medical experts (e.g., radiologists, pathologists). Here, the "ground truth" for each test is its defined engineering specification or a generally accepted laboratory standard (e.g., ISO guidelines for biocompatibility). The experts would be engineers, chemists, and quality control professionals, but their number and specific qualifications are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements among human readers or between human readers and AI outputs in diagnostic studies. For engineering tests, results are typically binary (pass/fail) based on objective measurements against pre-defined 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

Not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers. It's a medical device (aspiration tubing) used in a non-AI surgical/interventional procedure. Therefore, no MRMC study with human readers and AI assistance was conducted or described.

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

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the various non-clinical tests were:

• Pre-defined engineering specifications (e.g., dimensional requirements, tensile strength minimums).
• International and national standards (e.g., ISO 10993-1 for biocompatibility, IEC/EN 60601 series for electrical safety).
• Results from previously cleared predicate devices for comparison.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not applicable, as no training set exists for this device.

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INDIGO Aspiration Catheters and Separators:

As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

INDIGO Aspiration Tubing:

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

Penumbra Aspiration Pump:

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

The INDIGO® Aspiration System is comprised of several devices:

• INDIGO Aspiration Catheter ●
• Penumbra Aspiration Pump
• INDIGO Aspiration Pump Canister ●
• INDIGO Aspiration Tubing ●
• INDIGO Separator™ ●

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

The provided text describes the 510(k) summary for the Penumbra Indigo Aspiration System. The core of this submission is to demonstrate substantial equivalence to a predicate device, with an expanded indication for the treatment of pulmonary embolism.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • ITT (Intent-To-Treat) analysis population: 119 subjects
  • mITT (Modified ITT) population (primary for efficacy): 110 subjects (excluded subjects who received adjunctive treatments or thrombolytics intra-procedure through 48 hours post-procedure).
  • Safety endpoints: Evaluated based on the ITT population (119 subjects).
• Data Provenance: The Penumbra EXTRACT-PE trial was a prospective, multicenter, single-arm trial conducted at 22 centers in the U.S.

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

The document states: "An independent imaging core lab and a clinical events committee (CEC) reviewed safety endpoints data." It does not specify the exact number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience"). However, the involvement of an "independent imaging core lab" implies that imaging specialists (e.g., radiologists) were involved in assessing the imaging data for the RV/LV ratio, and a "clinical events committee" suggests physicians or clinical experts were involved in assessing safety events.

4. Adjudication Method for the Test Set

The document mentions an "independent imaging core lab" and a "clinical events committee (CEC)" reviewed endpoints data. This implies a form of expert review and consensus, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.

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

• No, an MRMC comparative effectiveness study was not done. The EXTRACT-PE trial was a single-arm trial, evaluating the device's performance without direct comparison to human readers or another treatment arm within the study design (though it established substantial equivalence to a predicate device based on its performance). Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable here, as this device itself is a mechanical aspiration system, not an AI-assisted diagnostic tool.

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

• Yes, in a sense. The "device performance" in this context refers to the Indigo Aspiration System as a standalone therapeutic device. The clinical trial evaluated the device's ability to achieve specific physiological outcomes (RV/LV ratio reduction) and safety outcomes when used by clinicians. Since it's a therapeutic device for mechanical thrombectomy, its performance is its standalone performance in treating patients. There isn't an "algorithm" being evaluated in the AI sense; rather, the mechanical system's efficacy is being assessed.

7. Type of Ground Truth Used

• The ground truth for efficacy (reduction in RV/LV ratio) was established by CTA (Computed Tomography Angiography) images assessed by an independent imaging core laboratory.
• The ground truth for safety (major adverse events) was established by clinical evaluation and review by a clinical events committee (CEC). This would incorporate clinical diagnoses, patient outcomes, and potentially imaging findings.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated for this submission. The Indigo Aspiration System is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's design and functionality are based on engineering principles and prior validated devices. The clinical study (EXTRACT-PE) served as a validation study for the expanded indication.

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

• Not applicable. As explained above, this device does not involve an AI/ML algorithm that requires a "training set" with established ground truth. The development and validation of this mechanical device rely on engineering design, bench testing, animal studies, and then human clinical trials to demonstrate safety and efficacy. The prior versions of the device (predicate and reference devices) would have undergone similar developmental and validation processes.

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INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4

As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

INDIGO Aspiration Tubing

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

Penumbra Aspiration Pump

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

The Indigo System (CAT RX and Separator 4) is designed to remove thrombus from the coronary and peripheral vessels by aspirating the proximal side of the thrombus. The intended users for this device are physicians who have received appropriate training in interventional techniques. The Indigo System (CAT RX and Separator 4) was most recently cleared under K163618.

The Indigo System (CAT RX and Separator 4) is designed to remove thrombus from the vasculature using continuous aspiration. The INDIGO CAT RX Aspiration Catheter is a dual lumen rapid exchange catheter that targets aspiration from the Pump directly to the thrombus, removing it via the INDIGO Aspiration Tubing and depositing it in the Pump Canister. The INDIGO Separator 4 may be used, if needed, to clear the lumen of the INDIGO CAT RX Aspiration Catheter should it become blocked with thrombus. The INDIGO CAT RX Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO CAT RX Aspiration Catheter may be provided with a rotating hemostasis valve and a peelable sheath. The INDIGO Separator 4 is provided with an introducer and torque device. The INDIGO CAT RX Aspiration Catheter and INDIGO Separator 4 are visible under fluoroscopy.

The Penumbra Engine Pump and Canister

The Penumbra Engine Pump ("Engine Pump") is an electromechanical device designed to create vacuum pressure for use with the Indigo System (CAT RX and Separator 4). The Engine Pump maintains vacuum pressure for 3 hours of continuous use and has an operating life of ≥ 500 hours. The pump can be used in environments with 100 - 240 Vac and 50/60 Hz. The Engine Pump is intended for use in operating rooms or interventional catheterizations laboratories. The Engine Pump and Canister do not come into contact with the patient. The Engine Pump Canister is a 1000 mL minimum volume reservoir which is an accessory to the Engine Pump. The Canister has a lid with a stop-flow filter to prevent excess fluid from entering the pump. The patient port on the lid is sized to accept the Suction Connector on the Indigo Aspiration Tubing.

The provided text describes the acceptance criteria and study for the Penumbra Engine Pump and Canister, not the entire Indigo Aspiration System (CAT RX and Separator 4) as a complete AI-assisted device. The document primarily focuses on demonstrating the substantial equivalence of the new pump and canister to a previously cleared predicate device. Therefore, information related to AI assistance, human reader improvement with AI, or complex ground truth establishment for diagnostic performance studies is not applicable or available in this context.

Here's an analysis of the provided information, focusing on the Penumbra Engine Pump and Canister:

1. Table of acceptance criteria and the reported device performance:

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

   • Sample Size: The sample sizes for the various tests were either N=1 or N=5, as indicated in the table above.
   • Data Provenance: The document does not explicitly state the country of origin. The studies were non-clinical bench-top and electrical safety/EMC testing, which are typically conducted in a controlled laboratory environment. The testing was performed by Intertek, a nationally recognized test laboratory. The nature of these tests (evaluating device components and performance, not patient data) means the retrospective or prospective classification of patient data is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the studies described are non-clinical engineering and performance tests for a medical device's electromechanical components (pump and canister), not a clinical study involving diagnostic interpretation or human experts establishing ground truth for patient outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where multiple readers evaluate cases and a consensus or tie-breaker mechanism is needed. The tests performed here are engineering verification tests with defined specifications and pass/fail criteria, not subjective interpretations 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:
   No, an MRMC comparative effectiveness study was not done. This document describes the clearance of an aspiration pump and canister, which are electromechanical components of a medical device system, not an AI-assisted diagnostic tool. Therefore, 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-only performance study was not done. This device is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth for these non-clinical tests was based on pre-defined design specifications, risk analysis, performance standards (e.g., IEC 60601-1, IEC 60601-1-2, EN ISO 10079-1), and guidance documents. For example, electrical safety tests were assessed against the requirements of IEC 60601-1, and dimensional inspections were assessed against product specifications.

8. The sample size for the training set:
   This information is not applicable. This submission details the clearance of a medical device (pump and canister) based on engineering verification, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   This information is not applicable for the same reason as point 8. There is no training set for an AI model discussed in this document.

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INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.

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

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

The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. The Indigo System was most recently cleared under K180105.

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

The Indigo Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Indigo Aspiration Catheter within the sterile field, providing a means for introducing vacuum during procedures. The Aspiration Tubing has a flow switch that allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is available in three inner diameters: 0.071 in [1.80mm] for IST1, 0.088 in [2.24mm] for IST2, and 0.110 in [2.79mm] for IST3 and IST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices.

Here's an analysis of the acceptance criteria and supporting study for the Penumbra Indigo Aspiration System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are primarily found in Section 1.10, "Summary of Non-Clinical Data," specifically subsections 1.10.1 (Biocompatibility) and 1.10.2 (Design Verification - Bench-top Testing).

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

The document does not explicitly state the specific numerical sample sizes for each test in the tables provided for "Biocompatibility" and "Design Verification." It mentions:

• For Biocompatibility, "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)."
• For Design Verification, "All benchtop studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures."

This indicates that appropriate (but unspecified) sample sizes were used according to established scientific and regulatory guidelines.

Data provenance: The tests were non-clinical (bench-top testing, lab-based biocompatibility, shelf-life, sterilization, packaging). Therefore, there is no "country of origin of the data" in the sense of patient data, nor is it retrospective or prospective in the usual clinical study context. These are laboratory studies performed by the manufacturer, Penumbra, Inc. (Alameda, CA, USA).

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

This information is not applicable to the provided document. The studies described are non-clinical, bench-top, and laboratory tests (biocompatibility, mechanical performance, sterility, shelf-life, packaging). These types of tests do not involve human experts establishing "ground truth" on a test set in the way a clinical study or AI algorithm evaluation would. The "ground truth" for these tests is defined by the objective measurement and adherence to established scientific and regulatory standards (e.g., ISO, AAMI standards, internal specifications).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical bench-top tests. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert review processes where there might be disagreement among reviewers, which is not relevant to chemical or mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not conducted as part of this submission. The document focuses exclusively on non-clinical (bench-top) testing to demonstrate substantial equivalence for a modified component (the 110 Aspiration Tubing) of an existing device. It does not involve human readers evaluating images or clinical outcomes, either with or without AI assistance.

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

No, a standalone performance study in the context of an algorithm or AI was not performed. This submission is for a physical medical device (aspiration system), not a software or AI diagnostic device.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Biocompatibility: Ground truth is established by standardized biological assays and observation against criteria defined in EN ISO 10993 guidelines.
• Design Verification (Bench-top Testing): Ground truth is established by objective measurements against predefined engineering design specifications, performance standards, and risk analyses.
• Shelf Life: Ground truth is established by measuring material degradation or performance changes over time, often using accelerated aging models and real-time stability studies, against pre-defined performance specifications.
• Sterilization: Ground truth is established by standardized microbiological and chemical tests (e.g., bioburden, sterility assurance level, EO residual levels) against criteria defined in EN ISO 11135, EN ISO 10993-7, AAMI TIR 28, and ANSI/AAMI ST72.
• Packaging: Ground truth is established by visual inspection and performance tests (e.g., seal integrity, transportation conditioning) to ensure sterility maintenance and device protection.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this submission is for a physical medical device, not an algorithm or AI.

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

This information is not applicable for the same reason as point 8.

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