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INDIGO Aspiration Catheters and Separators: As part of the Penumbra Embolectomy Aspiration System (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. Not for use in the coronaries or the neurovasculature.

INDIGO Aspiration Tubing: As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.

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

The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial and venous systems. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for the Aspiration Catheters with Aspiration Tubing is available. Intended users for this device are physicians who have received appropriate training in interventional radiology.

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous 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 use of the INDIGO Separator may not be necessary when using an INDIGO Aspiration Catheter with an I.D. of 0.054in [1.37mm] or larger. The INDIGO Aspiration Catheter is introduced through a guide catheter or long introducer 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 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. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Pump/Canister Tubing. The INDIGO Separator is provided with an introducer and torque device. The INDIGO Aspiration Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The INDIGO Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.

The Penumbra Pump MAX is the aspiration source for the INDIGO Aspiration System. The Penumbra Pump MAX operates using AC power and is designed to be portable if needed. The Penumbra Pump MAX provides vacuum of up to 29 inHz. The pump is available in both 110Vac and 230Vac versions.

The front face of the Penumbra Pump MAX has a display panel with a vacuum gauge, suction regulating valve, and power switch. The Penumbra Pump MAX connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter and connectors on each end to facilitate attachment to the pump's vacuum port. The tubing is provided pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System).

It's important to note that this document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of all validation studies. Therefore, some information requested might not be explicitly present or might be referenced by prior clearances.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "Visual Inspection," "Catheter Coating," and "Gross Leak" tests. For the "Simulated Use" test, it states that "Devices were delivered through the tortuous anatomical model..." but doesn't provide a specific number of devices or trials.

Data Provenance: The studies described in Section 1.11 Non-Clinical Data – KIT Configuration are benchtop or laboratory studies, not directly involving human or animal data for this specific submission. The original provenance for the predicate device and leveraged data (as mentioned in Sections 1.10 and 1.12) would be from previous submissions (K142870, K121917, K122756), which are not detailed in this document.

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

The described tests (Packaging Validation) are physical and mechanical property assessments. These typically do not involve human expert adjudication for ground truth, but rather engineering or quality control personnel assessing against defined specifications. Therefore, information about experts and their qualifications (like radiologists) is not applicable to these specific tests.

4. Adjudication Method for the Test Set

Not applicable for these types of engineering/benchtop tests. The results are binary (Pass/Fail) based on objective measurements against specifications.

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

No. The document describes a 510(k) submission primarily based on demonstrating substantial equivalence to a predicate device through non-clinical (benchtop) testing and leveraging data from prior clearances. It does not include an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a mechanical system, not an AI diagnostic tool.

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

No. This device is a mechanical aspiration system, not an algorithm.

7. The Type of Ground Truth Used

For the Packaging Validation tests, the "ground truth" is defined by the technical specifications and performance criteria established for the device's physical and mechanical properties. This is typically determined through engineering design documents and quality control standards.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical system, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a mechanical device.

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The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature.

The Penumbra Embolectomy Aspiration System's (INDIGO™ Aspiration System) fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) and its path to FDA clearance. It summarizes non-clinical data, including biocompatibility, bench-top testing, and an animal study, to demonstrate its safety and effectiveness and substantial equivalence to a predicate device. However, it does not include information about a study based on acceptance criteria for a device performance metrics or any kind of AI/algorithm performance. Specifically, it lacks the details needed to fill in the requested table and answer questions about AI/algorithm performance, ground truth, or expert involvement in such an evaluation.

Therefore, I cannot provide the requested information from the given text. The document focuses on demonstrating substantial equivalence through non-clinical testing for a medical device, not on evaluating an AI system's performance against specific acceptance criteria.

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The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.

The Penumbra Embolectomy Aspiration System's fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The provided document describes the Penumbra Embolectomy Aspiration System and its premarket notification for FDA clearance. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, including biocompatibility, bench-top testing, and animal studies. However, it does not include information about AI/algorithm performance, human reader studies, or explicit acceptance criteria for a device with AI components. The information requested in the prompt, such as acceptance criteria for an AI device, sample sizes for test sets (in the context of AI), ground truth establishment for AI models, and MRMC studies, are not present in this document because the device described is a physical medical device (embolectomy system), not an AI/software as a medical device (SaMD).

Therefore, I will provide the information based on the content available, noting where the requested details are not applicable or not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests with acceptance criteria being "All established requirements and acceptance criteria were met." and "All established acceptance criteria were met." or specific pass/fail results for biocompatibility.

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

This document describes physical device testing, not an AI/algorithm-based device with a "test set" in the computational sense.

• Biocompatibility: Tests were conducted on device materials. The specific number of samples for each test (e.g., number of animals for in vivo tests, number of cell cultures) is not provided.
• Bench-top Testing: Devices were assembled, packaged, and sterilized for mechanical testing. The specific number of devices tested for each parameter is not provided.
• Animal Study: Animal studies were conducted. The specific number of animals used is not provided.
• Data Provenance: The studies were conducted by Penumbra, Inc. (USA) and were part of their 510(k) submission to the FDA. They are considered prospective in the sense that they were designed and executed to fulfill regulatory requirements for the device.

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

This question is not applicable as the studies do not involve expert interpretation of data for AI ground truth. The "ground truth" for the device's performance is established by objective laboratory measurements and observations in animal models. For example:

• Biocompatibility: Standardized laboratory tests (e.g., L929 MEM Elution Test, Kligman Maximization) with clear pass/fail criteria.
• Animal Study: Observations by veterinary professionals and pathologists (e.g., "No abnormal gross or histology findings were noted") whose qualifications are implicit in their role in GLP-compliant studies but not explicitly detailed beyond their observational findings.

4. Adjudication method for the test set

Not applicable. There's no interpretive test set requiring adjudication in the context of an AI algorithm. The tests conducted are objective physical and biological assessments.

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 a physical medical instrument, not an AI system or an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. The device is a physical embolectomy system, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

• Regulatory Standards: Compliance with EN ISO 10993 -1 guidelines for biocompatibility and EN ISO 10555-1 for intravascular catheters, as well as FDA guidance documents.
• Objective Measurements: Results from standardized laboratory tests for physical properties (e.g., tensile strength, flow rate) and biological responses (e.g., cytotoxicity, hemolysis).
• In Vivo Observations: Direct observations and histological analysis in animal models (e.g., absence of vessel injury, absence of abnormal gross or histology findings).

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, not an AI system. There is no concept of a "training set" in the context of this device's evaluation.

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

Not applicable. As there is no training set for an AI algorithm, there is no corresponding ground truth establishment process in this context.

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