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The Panacea embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature, and is not intended for use in the coronary or neurovasculature.

The fundamental mechanism of action is temporary vessel occlusion combined with mechanical balloon embolectomy and aspiration through a guide catheter. The sheath provides vessel access. The occlusion balloon catheter is intended for temporary vessel occlusion and the guide catheter functions to remove emboli and thrombi. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the 510(k) submission for "The ICHOR Panacea Vascular Embolectomy Catheter System." It focuses on demonstrating substantial equivalence to a predicate device through in vitro testing. However, the document does not provide the detailed information required for the questions regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance.

Here's why and what's missing:

• This device is a physical medical device (catheter system), not an AI/algorithm-based diagnostic or therapeutic device. The questions posed are highly relevant to AI/ML medical devices where performance metrics like sensitivity, specificity, AUC, etc., are crucial, and the "ground truth" establishment, expert adjudication, and human reader comparative studies are standard.
• The "testing" mentioned is for a physical device. The "Summary of Testing" section lists various in vitro tests (e.g., "Balloon performance and dimensions," "Tensile testing," "Clot capture," "Biocompatibility," "Sterilization," "Animal testing"). These are standard for clearing a physical medical device and ensure its mechanical properties, safety, and functionality. They are not about the performance of an AI algorithm.
• There is no mention of "acceptance criteria" in the context of an AI's diagnostic performance. The "acceptance criteria" referred to in the document would be pre-determined specifications for the physical properties and performance of the catheter (e.g., balloon burst pressure, tensile strength limits, successful clot removal percentage in an in vitro model).
• No "study" is described that involves human readers, ground truth established by experts, or AI performance metrics. The document states "All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements," referring to the physical tests.
• No data provenance, sample sizes for AI test/training sets, or expert qualifications are discussed. These concepts are not applicable to the premarket notification for this physical device.

Therefore, I cannot answer the questions based on the provided text, as the text describes the submission for a physical medical device and not an AI/ML-driven device.

To answer your questions, I would need a 510(k) summary or clinical study report for an AI-based medical device that performs a diagnostic or prognostic task.

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The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.

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

The Artemis™ Neuro Evacuation Device, is a surgical instrument designed to aid a physician in the removal of tissue and/or fluid during image-guided neurosurgery. The Artemis Wand has two functions. These functions are control and transfer of aspiration and generation of rotational energy. Aspiration is generated by a Penumbra Aspiration Pump, which the Artemis Wand connects to through its flexible tubing. The Artemis Wand has a rigid hypotube containing a wire to facilitate removing tissue and/or fluid with the assistance of rotational energy and aspiration.

The Artemis Wand is designed to be image-guided, allowing visualization of the procedure. The method of removal is vacuum aspiration, which draws the tissue and/or fluid into the lumen of the Wand hypotube. The integrated wire is fully contained within the lumen of the Wand hypotube, and has rotational capability facilitating movement of any tissue and/or fluid that may otherwise clog the hypotube lumen.

The provided text describes the Penumbra Artemis™ Neuro Evacuation Device and its substantial equivalence to a predicate device, the Apollo System. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting a comparative effectiveness study with human readers or a standalone algorithm performance study.

Therefore, the information required to answer the following points is not available in the provided text:

• A table of acceptance criteria and the reported device performance: While some tests are listed with "100% Pass" or descriptions like "Non-toxic," specific numerical acceptance criteria (e.g., minimum aspiration rates, maximum force tolerances) and their corresponding performance values are not detailed. The provided information summarizes categories of tests and their overall success.
• Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The text mentions "Design Verification (Bench-Top Testing)" and "Simulated Use" but does not specify the sample sizes (number of devices or simulated clots) used for these tests. Data provenance is also not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant to the non-clinical, bench-top testing described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to the non-clinical testing.
• 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 study type is not mentioned or implied, as the device is a mechanical neuro evacuation device, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a mechanical instrument.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and successful execution of the test methods (e.g., passing a specific force test, achieving a certain vacuum level, being non-toxic per ISO standards).
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here is a summary of the acceptance criteria and study information that is mentioned:

Acceptance Criteria and Reported Device Performance (Based on available summary data):

Additional Information from the text:

• Study Types: The studies conducted are primarily non-clinical bench-top testing and biocompatibility testing. This is a type of standalone performance testing in the sense that it evaluates the device's physical and biological properties in a controlled environment, not its performance in humans or with human interaction for diagnostic purposes.
• Ground Truth for Non-clinical Tests: For biocompatibility, the ground truth is established by the specified international and FDA guidelines (EN ISO 10993-1, 21 CFR, Part 58 Good Laboratory Practices). For bench-top testing, the ground truth is against pre-defined product specifications and engineering requirements.
• No Multi-Reader Multi-Case (MRMC) Study or AI/ML Algorithm Performance: The Artemis™ Neuro Evacuation Device is a physical medical instrument, not an AI-powered diagnostic tool. Therefore, studies involving human readers, AI algorithms, training sets, or expert consensus for image interpretation are not applicable and were not performed or reported in this document.

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Penumbra Aspiration Catheters and Separators: As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Penumbra Aspiration Tubing: As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the 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 Penumbra Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the coronary and peripheral vasculature. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional radiology. The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the 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 0.054 in or larger. The 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 Aspiration Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, the 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 Penumbra Pump MAX, which is connected using the Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Separator is provided with an introducer and torque device. The Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheter and Separator are visible under fluoroscopy. The Penumbra Pump MAX is the aspiration source for the Penumbra 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 inHg. The pump is available in both 110Vac and 230Vac versions. The front face of the pump has a display panel with a vacuum gauge, vacuum regulator dial, and power switch. The pump 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.

The provided document is a 510(k) premarket notification for the Penumbra Aspiration System. It details the device's indications for use, its classification, and a comparison to predicate and reference devices. However, the document primarily focuses on demonstrating substantial equivalence through non-clinical (benchtop) and animal study data, largely leveraging existing data from previously cleared similar devices.

Crucially, this document does NOT contain information about specific "acceptance criteria" or "device performance" in terms of clinical outcomes, nor does it describe a study involving human subjects or experts for establishing ground truth for AI/algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specified sub-points (table of acceptance criteria/performance, sample size, experts, adjudication, MRMC study, standalone performance, type of ground truth, training set details) because this information is not present in the provided text.

The document discusses:

• Leveraged Non-Clinical Data (Section 1.10): This section lists benchtop tests (Friction, Visual & Dimensional, Pouch Seal Strength, Flow Rate, Tensile, Elongation, Bond Strength, Hub Air Aspiration, Torsion, Burst, Simulated Use, Particulate, Flexibility, Packaging, Corrosion). It states that "all established requirements and acceptance criteria were met," but it does not specify what those acceptance criteria were in measurable terms (e.g., "flow rate X L/min," "tensile strength Y N"). It also does not define "device performance" in the way requested (e.g., diagnostic accuracy, sensitivity, specificity).
• Leveraged Animal Studies (Section 1.11): This section summarizes findings from design validation in GLP animal testing, noting "No vessel injury," "No abnormal gross or histology findings," and "no significant vascular response." This is performance data in an animal model, but not clinical performance in humans, nor does it relate to acceptance criteria for an AI/algorithm-driven device.

In summary, the provided text describes the regulatory clearance process for a medical device (an aspiration system) based on substantial equivalence to existing devices, supported by benchtop testing and animal studies. It does not contain the kind of information typically found in a study proving an AI/algorithm-driven device meets specific clinical acceptance criteria, which would involve human data, expert review, and metrics like accuracy, sensitivity, or specificity.

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