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The Ruby XL System is indicated for arterial and venous embolizations in the peripheral vasculature.

The Ruby XL System is comprised of a platinum embolization coil attached to a composite delivery pusher, and the Penumbra Detachment Handle. The coil/delivery pusher is packaged separately from the Penumbra Detachment Handle.

The provided document is a 510(k) Pre-Market Notification for the Ruby XL System, a vascular embolization device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on a clinical or performance study in the way an AI/ML device would.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, data provenance, expert ground truth, MRMC study, standalone performance) is not applicable to this document.

This submission focuses on bench-top performance testing, biocompatibility, and shelf-life, establishing substantial equivalence based on the device's physical characteristics, materials, and mechanical performance compared to a predicate embolization coil system. No AI/ML components are mentioned or evaluated in this regulatory filing.

Here's a breakdown of what is provided and why the AI/ML-specific questions are not applicable:

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

• This document does not present acceptance criteria in the typical sense of numerical thresholds for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various bench-top performance tests (Dimensional/Visual, Packaging, Radiopacity, Friction, Fatigue Resistance, Torsional Resistance, Stiffness, Simulated Use, Corrosion, Tensile, MRI Compatibility) and states that these tests were "used in support of the subject device to determine substantial equivalence."
• No specific reported numerical performance values are given for these tests beyond the general statement that they substantiate the device's performance.

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

• Not applicable as no AI/ML test set was used. The "test set" here would refer to the physical devices undergoing bench-top testing. Data provenance is not relevant for physical device testing in this context.

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

• Not applicable. Ground truth, in the AI/ML context, refers to expert labeling or an objective standard against which an algorithm's output is compared. For this device, "ground truth" would be the established physical and mechanical properties and material standards. No human experts are described as defining a "ground truth" for a test set of images or data to evaluate an algorithm.

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

• Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/ML ground truth, which is not part of this submission.

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 is a physical medical device (embolization coil system), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant.

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

• No. This is a physical medical device.

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

• Not applicable for an AI/ML context. The "ground truth" for this device's performance is established engineering and material science standards and physical measurements.

8. The sample size for the training set

• Not applicable as no AI/ML algorithm was trained.

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

• Not applicable as no AI/ML algorithm was trained.

Summary based on the provided document:

The Ruby XL System is a medical device (vascular embolization device), not a software/AI/ML product. The 510(k) submission demonstrates substantial equivalence to a predicate device (Penumbra Coil System and POD System) based on:

• Indications for Use: The subject device is indicated for arterial and venous embolizations in the peripheral vasculature, which is a subset of the predicate's indications.
• Design and Materials: The document states "SAME" for various material and construction attributes, coil dimensions, detachment mechanism, sterilization method, and method of supply, indicating identical or highly similar characteristics to the predicate.
• Non-Clinical Safety and Performance Data: Bench-top testing (e.g., Dimensional, Packaging, Radiopacity, Friction, Fatigue, Stiffness, Simulated Use, Corrosion, Tensile, MRI Compatibility) and Biocompatibility testing were performed. These tests are the "study" that substantiates the device's performance and safety, leading to the determination of substantial equivalence. The document explicitly states "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."

Therefore, the requested AI/ML specific criteria and study details are not relevant to this 510(k) submission for a physical medical device.

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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 thrombolytic drug therapy or who failed thrombolytic drug 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 thrombolytic drug therapy or who failed thrombolytic drug 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 3D Revascularization Device
• Penumbra Aspiration Pump
• . Penumbra Aspiration Pump Canister/Tubing
• Penumbra Aspiration Tubing
• Penumbra Separator .

The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. The Reperfusion Catheter delivers aspiration from the pump directly to the site of occlusion to remove the clot. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. Alternatively, a Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. 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 Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. The Penumbra Reperfusion Catheter is connected to the Penumbra Aspiration Pump using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel, rotating hemostasis valve (RHV), peelable sheath, and optionally, SENDit Technology (cleared under K191946). The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.

The provided text describes specific acceptance criteria and performance data for the Penumbra System (Reperfusion Catheter RED 72). However, it notes that no animal or clinical studies were conducted for this particular device submission (K242104). The evidence for meeting acceptance criteria comes solely from bench and biocompatibility testing. Therefore, information regarding sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, which are typically associated with clinical or AI/algorithm performance studies, are not applicable or available in this document.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The document states that "No animal or clinical study was conducted as bench and biocompatibility testing were determined sufficient for verification and validation purposes." The tests listed are primarily bench (in-vitro) tests on manufactured units or material samples. The specific number of units or samples tested for each bench test is not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these engineering and biocompatibility tests is based on established scientific principles, industry standards, and specified material properties, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set: Not applicable. Adjudication methods are typically employed in clinical studies or studies involving human assessment of data, which were not performed in this case.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was performed as this device is a physical medical device (catheter system) and not an AI-powered diagnostic or assistive tool for human readers.

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

7. The type of ground truth used:
* Bench Testing: Engineering specifications, material properties, and functionality performance standards.
* Biocompatibility Testing: Established biological safety standards (ISO 10993 series, USP standards, 21 CFR Part 58 GLP).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Access25 Delivery Microcatheter is indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.

The Access25 Delivery Microcatheter (Access25) is a single lumen medical device designed to aid a physician in accessing distal vasculature when used in conjunction with a guide catheter and micro guidewire. The Access25 Delivery Microcatheter is supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired.

This document pertains to the Access25™ Delivery Microcatheter by Penumbra, Inc. This is a medical device and not an AI/ML powered device, therefore some relevant sections of the query will not be applicable.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

8. The sample size for the training set:

Not applicable. This is 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 this is not an AI/ML algorithm, there is no training set or its associated ground truth establishment process. The "ground truth" in the device development context refers to the established performance requirements and standards against which the device is tested.

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The Element Vascular Access System is indicated for the introduction of therapeutic or diagnostic devices into the vasculature.

The Element Vascular Access System is a medical device system designed to provide a conduit for introduction of therapeutic devices to the peripheral, coronary, and neurovascular anatomy. This device is a three-component system comprised of the BMX81 Delivery Catheter, Penumbra (Neuron 5F) Select Catheter, and a Dilator. The BMX81 Delivery Catheter can be used individually with a 0.038 in [0.97 mm] guidewire or together with the Neuron 5F Select Catheter to access the desired anatomy. The sheath component of the device contains an inner diameter of 6 French (Fr) and lengths ranging from 55 - 115 centimeters (cm).

The provided text is a 510(k) summary for the Penumbra Element Vascular Access System. It describes the device, its intended use, and comparison to predicate devices, along with a summary of performance data. However, this document does not contain information about studies involving artificial intelligence (AI) or machine learning (ML) components.

The "Performance Data" section (1.11 and 1.11.1) outlines bench performance testing, which are standard engineering tests for medical devices (e.g., dimensional, tensile, particulate, leakage, fluoroscopy, friction, corrosion, elongation, stiffness, flexibility). There is no mention of an algorithm, AI, or ML being part of the device or its function.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types, or training set details for an AI/ML model, as no such model is described in this submission.

The "K242520" 510(k) is for a physical medical device (catheter introducer) and not for a software as a medical device (SaMD) or a device with an AI/ML component that requires the types of studies you are asking about (like diagnostic or image analysis AI).

If you have a different document that details an AI/ML component of this device, please provide that. Based solely on the provided text, the device itself is a conventional vascular access system.

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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 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 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 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 Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.

The provided text is a 510(k) summary for the Penumbra Indigo® Aspiration System - Lightning Bolt Aspiration Tubing (K242075). It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device (K223186).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the subject device meets specific clinical performance acceptance criteria in a standalone study against a predefined clinical benchmark. The studies described are primarily bench-top (non-clinical) tests to verify that the subject device performs similarly to the predicate device and functions as intended.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed, stating that the subject device met all acceptance criteria. However, it does not provide a table detailing specific quantitative acceptance criteria or corresponding device performance values for most tests. Instead, it offers general statements of compliance or similarity to the predicate device.

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

The document does not explicitly provide the sample sizes (number of units or test iterations) for each specific bench-top test. It generally references "testing performed on the subject Lightning Bolt Aspiration Tubing device."

The data provenance is non-clinical bench testing, conducted by the manufacturer, Penumbra, Inc. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence. There is no information about country of origin of the data beyond implicitly being from testing conducted by the US-based manufacturer.

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

For the non-clinical bench-top tests described, the concept of "ground truth" as established by medical experts (e.g., radiologists) is not applicable. These tests evaluate engineering and material performance against predefined specifications, often based on industry standards or internal design requirements. The "ground truth" for these tests would be the physical properties and performance of the device as measured in the lab.

4. Adjudication Method for the Test Set

Since the tests are non-clinical bench tests evaluating engineering performance, an adjudication method (like 2+1, 3+1 for clinical endpoints) is not relevant. Test results are typically objective measurements against a Pass/Fail criterion.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no information on the effect size of human readers improving with or without AI assistance, as this is not an AI device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not done. This device is physical medical tubing, not an AI algorithm.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" is based on:

• Engineering specifications and design requirements for mechanical, dimensional, and material properties.
• Industry standards (e.g., ISO for sterility, various IEC standards for electrical safety).
• Performance of the predicate device as a benchmark for comparison (e.g., "performed similarly to the predicate device").

8. Sample Size for the Training Set

Not Applicable. This is a physical medical device (tubing), not a machine learning algorithm. Therefore, there is no "training set."

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

Not Applicable. There is no training set 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 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. TraX may be used with its prepackaged Aspiration Catheter to facilitate access 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, Select Catheter, introducer, and TraX. TraX compatibility is limited to its prepackaged Aspiration Catheter. The INDIGO Separator may be provided with an introducer and torque device.

The provided document is a 510(k) Premarket Notification from the FDA for the Penumbra, Inc. Indigo® Aspiration System - Aspiration Catheter 6X. It details the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical (bench-top) performance testing.

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as it is related to a physical medical device (catheter) rather than a diagnostic algorithm or AI. Instead, it lists various bench-top performance tests conducted. For each test, the implicit acceptance criterion is that the device met all requirements.

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 primarily describes bench-top testing for a physical device. It does not mention a "test set" in the context of data used for an algorithm or AI. Therefore, concepts like sample size for a test set, country of origin, retrospective or prospective data are not applicable. The data provenance would be from internal laboratory testing conducted by Penumbra, Inc.

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 as the document describes bench-top performance testing of a physical medical device (catheter), not a diagnostic algorithm or AI that would require expert-established ground truth.

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

This information is not applicable for the same reason as point 3.

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

An MRMC comparative effectiveness study was not done. The study described is for a physical medical device, not an AI or diagnostic tool that would involve human readers.

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

A standalone performance study in the context of an algorithm or AI was not done. The performance evaluation was of the physical device's mechanical, material, and functional properties on a test bench.

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

For the bench-top tests, the "ground truth" would be defined by engineering specifications, material science standards, and functional performance benchmarks for the device. For example, a tensile test would measure the force required to break the catheter, with the "ground truth" being the specified minimum tensile strength that the device must meet according to its design requirements. Similarly, biocompatibility is assessed against ISO 10993-1 standards.

8. The sample size for the training set

This information is not applicable as the document describes bench-top performance testing of a physical medical device, not an AI or algorithm that uses 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.

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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 Select+ Catheter is an accessory within kitted configurations of the INDIGO Lightning Flash Aspiration System. The Select+ Catheter is used to aide in access to the site of occlusion and is removed prior to initiating aspiration with the aspiration catheter. The use of the Select+ Catheter to facilitate access to the site of the occlusion is an optional procedural step for INDIGO Lightning Flash Aspiration Catheters. The device is provided sterile and intended for single use only.

The provided text is a 510(k) summary for the Indigo® Lightning Flash Aspiration System - Select+™ Catheter. It does not describe a study involving an AI device or software, nor does it provide the detailed information requested in the prompt regarding acceptance criteria and performance of an AI-powered device.

Instead, this document focuses on establishing substantial equivalence of a new catheter (Select+™ Catheter) to a previously cleared predicate device (Indigo Aspiration System – Lightning Flash Select Catheter) and a reference device (Neuron Max System - Select Catheter).

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance for an AI device.
2. Sample size used for a test set for an AI device or data provenance.
3. Number and qualifications of experts for ground truth establishment for an AI device.
4. Adjudication method for an AI device.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study for an AI device.
6. Standalone performance details for an AI algorithm.
7. Type of ground truth used for an AI device.
8. Sample size for the training set of an AI device.
9. How ground truth for the training set of an AI device was established.

The document states, under "7.5 Summary of Performance Data – Animal, Clinical", that "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." This further confirms that the information requested for an AI-based study is not present.

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The MIDWAY Delivery Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The MIDWAY Delivery Catheters are single lumen percutaneous catheters designed to provide a conduit for introduction of interventional devices to the peripheral, coronary, and neuro vasculature. The MIDWAY Delivery Catheter is a single lumen, coil-reinforced, variable stiffness catheter with a radiopaque marker band on the distal end and a Luer hub on the proximal end. The MIDWAY Delivery Catheter is compatible with sheaths and guide catheters appropriately sized for the outer diameter of the MIDWAY Delivery Catheter. The MIDWAY Delivery Catheter has a hydrophilic coating on the distal segment of the catheter shaft.

The document provided is a 510(k) summary for a medical device (MIDWAY Delivery Catheter) seeking substantial equivalence to existing predicate devices. It does not contain information about a study proving the device meets acceptance criteria for a clinical or AI performance study. Instead, it outlines bench performance testing and other non-clinical data to demonstrate substantial equivalence to legally marketed predicate devices.

Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the information provided.

However, I can extract the acceptance criteria and confirmed performance for the bench performance tests that were conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The following information is not present in the provided document:

• 2. Sample size used for the test set and the data provenance: The document refers to "bench performance testing" which are laboratory-based tests of physical properties and functionality, not a clinical "test set" of patient data. The sample sizes for these bench tests are not specified, nor is data provenance (country of origin, retrospective/prospective).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this was bench testing, not a study requiring expert-established ground truth on clinical data.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. The device is a physical delivery catheter, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the "ground truth" would be established engineering specifications and industry standards for mechanical performance, material integrity, and functionality.
• 8. The sample size for the training set: Not applicable, as this is bench testing for a physical device, not an AI/ML model that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Overall Study Information:

The study described is a series of bench performance tests and confirmation of existing data from reference devices (MIDWAY 43 Delivery Catheter and MIDWAY 62 Delivery Catheter were compared to Reperfusion Catheter RED 43 (K222808) and Reperfusion Catheter RED 62 (K203440), respectively). The primary purpose was to demonstrate substantial equivalence to predicate devices for a new indication (introduction of interventional devices into peripheral, coronary, and neuro vasculature).

Key Findings:

• All listed bench performance tests (Simulated Use, Compatibility, Particulate, Coating Integrity, Surface Integrity, Tensile Strength, Burst Pressure) met their respective acceptance criteria.
• The subject devices share the same design, materials, and manufacturing as their reference devices.
• Other performance data for the reference devices (Biocompatibility, Shelf Life, Sterilization, Packaging) were also used to support the subject device.
• No animal or clinical studies were deemed necessary for the 510(k) submission.
• The conclusion is that the MIDWAY Delivery Catheters are substantially equivalent to the predicate devices, perform as intended, and do not raise new questions of safety or effectiveness.

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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 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.

This document describes a 510(k) premarket notification for the Indigo® Aspiration System - Lightning® Flash, which is an embolectomy catheter used for removing fresh, soft emboli and thrombi.

Here's an analysis of the provided text with respect to acceptance criteria and the study:

1. Tabulation of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The same Design Verification test methods, specifications, and acceptance criteria were used for the subject device compared to the predicate." and "The subject Indigo Aspiration System – Lightning Flash Aspiration Tubing met all established requirements." However, the exact quantitative acceptance criteria are not explicitly listed in the provided text. The performance is reported as meeting "all established requirements."

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

The document states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no test set of human/animal data in the traditional sense, and thus no data provenance for such studies.

The testing was "bench-top" and would involve physical devices. The number of devices tested is not specified in the provided text.

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

As no animal or clinical study was conducted, there are no experts used to establish ground truth for a test set in the context of clinical outcomes. The "ground truth" for bench testing would be predefined engineering specifications, which are established by the device manufacturer's design and engineering teams. The qualifications of these individuals are not stated.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set involving human/animal data requiring adjudication. Bench testing typically relies on pass/fail criteria against engineering specifications.

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

A MRMC comparative effectiveness study was NOT done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no effect size reported for human readers with or without AI assistance.

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

This device does not appear to be an AI/software-driven diagnostic device requiring standalone algorithm performance evaluation. The "additional software features" mentioned would likely be related to control or operational aspects of the device, not image analysis or diagnostic capabilities. Therefore, a standalone performance evaluation of an algorithm in this context is not applicable/not reported.

7. Type of Ground Truth Used:

For the bench-top testing, the ground truth was engineering specifications and established requirements (e.g., dimensional tolerances, tensile strength values, vacuum levels, system compatibility).

8. Sample Size for the Training Set:

This is not applicable as the document does not describe the development or training of any AI or machine learning models. The device is a physical medical device (embolectomy catheter system).

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

This is not applicable as there is no training set mentioned or implied for this device.

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The Penumbra LP Coil System is indicated for the embolization of:

• · Intracranial aneurysms
• · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• · Arterial and venous embolizations in the peripheral vasculature

The Penumbra LP Coil System is comprised of the Penumbra LP Coil, a platinum embolization coil attached to a composite delivery pusher with a radiopaque positioning marker and the Penumbra LP Coil Detachment Handle.

The coil/delivery pusher is packaged separately from the Penumbra LP Coil Detachment Handle. Penumbra LP Coil includes the following coil configurations:

• Ruby Coil LP ●
• Packing Coil LP ●
• PTC Coil LP ●
• Helical Coil LP ●
• Hybrid Coil LP ●

The provided text is a 510(k) summary for the Penumbra LP Coil System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through an independent study with a defined ground truth, a test set, or expert adjudication.

Therefore, many of the requested data points (sample size of test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of submission.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes bench-top testing performed to evaluate the physical and mechanical properties of the subject device and demonstrate substantial equivalence to the predicate device. For each attribute, the "Specification" acts as the acceptance criteria, and the "Results" indicate the device met these criteria.

Additionally, the document states:

• Biocompatibility Testing: The Penumbra LP Coil System was determined to be biocompatible according to the requirements of ISO 10993-1. Specific tests for the Detachment Pusher (Cytotoxicity, Hemocompatibility) and Introducer Sheath (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Material-Mediated Pyrogenicity) were performed.
• Sterilization Testing: The device was tested to be sterile using identical acceptance criteria and testing methods as the predicate device in accordance with ISO 11135 and ISO 10993-7. The Sterilization Assurance Level (SAL) requirement is ≥10-6.

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

The document does not specify a "test set" in the context of clinical data or images for an AI/CAD/software device. The tests performed are bench-top mechanical, chemical, and biological evaluations. The sample size for each bench-top test is not explicitly mentioned.

Data Provenance: Not applicable in the context of clinical data for this type of submission. The data is from laboratory testing (bench-top, biocompatibility, sterilization).

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

Not applicable. This submission is for a physical medical device (embolization coil system), not a diagnostic device relying on expert interpretation of images or clinical data. Ground truth, in this context, refers to established engineering specifications and international standards (e.g., ISO 10993-1, ISO 11135, ISO 10993-7).

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the sense of clinical cases requiring expert adjudication. The "Pass" results for bench-top tests indicate compliance with predefined engineering specifications.

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

Not applicable. This is a physical medical device; it is not an AI/CAD/software device intended to assist human readers.

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

Not applicable. This is a physical medical device; it is not a standalone algorithm.

7. The Type of Ground Truth Used

For the bench-top testing, the "ground truth" or reference for evaluating performance was engineering specifications, product specifications, and relevant international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 and ISO 10993-7 for sterilization).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set.

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