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The ICHOR 14F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from venous blood vessels. The System is intended for the peripheral vasculature and is not intended for use in the coronary or neurovasculature.

The ICHOR 14F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The System is intended for the peripheral venous vasculature (nominal size 8-14mm).

• The System is composed of three catheters: (1) Introducer Sheath, (2) Guide Catheter, and (3) Balloon Catheter and accessories.
• The outermost catheter is the Introducer Sheath, which travels to the occlusion site over the dilator. The Introducer Sheath is placed proximal to the occlusion and anchored into place by inflating the occluding balloon located at the distal tip. The balloon on the Introducer Sheath also serves to occlude flow.
• The Guide Catheter, composed of the Basket Catheter telescoped within the Guide Catheter Sheath, is passed through the Introducer Sheath. When in place, the Guide Catheter Sheath, which serves as the capturing sleeve, is retracted proximally allowing a nitinol basket to expand within the vasculature proximal to the occlusion.
• The Balloon Catheter is passed through the Guide Catheter and extended past the occlusion. The treatment balloon is inflated distal to the occlusion, and the Balloon Catheter is pulled proximally towards the basket until the occlusion is contained inside the basket. If desired the Guide Catheter can introduce aspiration to apply negative pressure to guide embolic material into the basket.
• The accessories include a dilator, flush adapter, two 3cc syringes, a Tuohy Borst, and four extension lines with one-way stopcocks.

The provided text is a 510(k) premarket notification for the ICHOR 14F Embolectomy System. It details the device's indications for use, its description, and a comparison to predicate and reference devices. It also lists the non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain information about:

• Acceptance criteria in tabular format with reported device performance (beyond general statements about meeting requirements).
• Sample sizes used for the test set (for algorithm performance).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific algorithm performance claims.
• Sample size for the training set (for an AI/algorithm).
• How the ground truth for the training set was established.

This is because the ICHOR 14F Embolectomy System is a mechanical thrombectomy system, not an AI-powered diagnostic or therapeutic device. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical bench testing and animal study performed to demonstrate the physical and functional aspects of the device, as well as its biocompatibility and sterilization efficacy, in comparison to existing predicate devices.

Therefore, I cannot fulfill most of the requested points as they are relevant to AI/algorithm-based medical devices, which this product is not.

Here's the information that can be extracted or inferred from the provided text, primarily regarding the non-clinical testing aspects of this mechanical device:

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

The document lists various tests performed, implying that acceptance criteria were met for each. However, it does not provide specific quantitative acceptance criteria or detailed reported performance results in a table. It only states that the device "met the requirements" or that testing "confirms these do not raise new questions of safety and effectiveness."

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

• Test Set Sample Sizes: Not specified for each individual bench test or the animal study in terms of specific numbers of devices or animals.
• Data Provenance: Not explicitly stated, but typically for medical device testing, it would be conducted in controlled laboratory or GLP (Good Laboratory Practice) animal study environments. It's not "data" in the sense of patient data. The animal study was a "GLP study," implying a controlled, prospective experimental design.

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

• Not applicable for this device type. There is no "ground truth" derived from expert image interpretation or clinical outcomes data in the context of an AI study. Mechanical device testing relies on measurable physical properties and observed biological responses.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are relevant for human interpretation of data, often in AI or clinical studies. This involves mechanical and biological testing.

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 not an AI-assisted device. Therefore, no MRMC study was conducted or is relevant.

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

• No. This is not an AI algorithm.

7. The type of ground truth used

• Not applicable in the context of AI. For this device, "ground truth" is established by:
  • Bench Test Standards: Adherence to established engineering and material science standards (e.g., tensile strength, balloon compliance) and internal specifications.
  • Biocompatibility Standards: Compliance with ISO 10993 series for biological evaluation of medical devices.
  • Animal Models: Live animal physiological responses and pathological findings in a controlled GLP study setting comparing the device to a predicate/comparator.

8. The sample size for the training set

• Not applicable. This device does not use an AI algorithm that requires a training set.

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

• Not applicable. This device does not use an AI algorithm that requires a training set.

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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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