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The Artix™ MT thrombectomy device is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels

· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Artix™ MT thrombectomy device is intended for use in the peripheral vasculature.

The Artix™ Thin-Walled Sheath is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

· Use as a conduit for endovascular devices.

· Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures.

The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.

The Artix™ MT is a single-use, over-the-wire catheter device used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The Artix MT is packaged with the following components: Artix MT (3-6 mm or 4-8 mm) Cleaning accessory 1-Way Stopcock The Artix MT is inserted over-the-wire through a compatible sheath (such as the Artix Thin-Walled Sheath) and advanced until its proximal marker band is distal to the target thrombus. The self-expanding element is deployed by retracting the delivery catheter. Thrombus is engaged and removed by retracting the Artix MT into the sheath and out of the patient. Once the procedure is complete, the system is completely withdrawn from the patient.

The Artix™ Thin-Walled Sheath ("Artix Sheath") is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for endovascular devices. The Artix Sheath also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix Sheath is packaged with the following components: Artix Thin-Walled Sheath (65 cm or 90 cm) Sheath Dilator (0.035" guidewire compatibility) Funnel Catheter and Funnel Catheter Dilator (0.035" guidewire compatibility) Funnel Loading Tool (2) Large Bore Syringe, 30 mL The Artix Sheath is inserted over-the-wire and advanced to a desirable position. Any compatible endovascular device, such as the Artix MT, can then be inserted through the Artix Sheath for access into the peripheral vasculature. The provided funnel catheter accessory can also be inserted through the Sheath and deployed to provide flow occlusion of the vessel during the procedure to aid with the system's clot ingestion. Compatible endovascular devices, such as the Artix MT, can be used through the 6 Fr inner diameter of the funnel catheter as well. The provided 30 mL syringe can be used to aspirate clot in the vessel or Sheath and infuse contrast media and other fluids as required. Once the procedure is complete, the funnel catheter (if used) is removed prior to withdrawal of the entire system from the patient, and standard 7 Fr closure devices can be used.

The provided document describes the 510(k) premarket notification for two devices: Artix™ MT and Artix™ Thin-Walled Thrombectomy Sheath. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about acceptance criteria or studies involving human expert performance (such as MRMC studies, specific ground truth established by experts, or sample sizes for test/training sets relevant to AI/software performance).

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving device meets those criteria in the context of AI/software performance with human-in-the-loop. The document exclusively discusses the substantial equivalence of physical medical devices based on their design, materials, and non-clinical performance (e.g., burst strength, tensile strength, simulated use, biocompatibility).

The "study" mentioned in the document refers to a series of non-clinical tests conducted to demonstrate that the devices perform as intended and are as safe and effective as their predicate devices. These tests are not related to AI or human reader performance.

Here's an overview of the information that is available in the document, which primarily concerns the physical characteristics and performance of the devices:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria in a quantitative table with reported device performance in the way one might expect for AI or software. Instead, it lists various non-clinical tests (e.g., Biocompatibility, Sterilization, Packaging Testing, Visual and Dimensional Inspections, Simulated Use Testing, Hemostasis, Burst, Corrosion, Radiopacity, Radial Force, Chronic Clot Analog for Artix MT; and similar tests for Artix Thin-Walled Sheath) and states that "The passing results demonstrate that the subject device meets biological safety requirements" (for biocompatibility) and that "verification and validation testing were identified to support the substantial equivalence" and "The testing provided supports the Artix MT's substantial equivalence." This implies that the devices met their internal acceptance criteria for these physical and functional tests. However, the specific numerical acceptance criteria and performance outcomes for each test are not detailed in this summary.

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

• Test Set (Non-clinical): The document does not specify the sample sizes for the individual non-clinical tests conducted (e.g., how many units were tested for burst strength, or simulated use).
• Data Provenance: Not applicable in the context of device performance data presented, as it refers to non-clinical, lab-based testing of the physical devices.

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 the performance of these physical medical devices is established through engineering specifications, material science, and physical testing protocols, not through expert consensus on interpretation of medical images or patient outcomes.

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

• Not applicable. This concept typically applies to human reader studies where disagreements in interpretations need to be resolved. For non-clinical device testing, results are typically 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:

• No. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This means no human-in-the-loop or clinical studies were performed or are discussed here. MRMC studies are not relevant to this submission.

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

• Not applicable. These are physical thrombectomy devices, not AI algorithms.

7. The type of ground truth used:

• For the non-clinical tests ("verification and validation testing"), the "ground truth" is defined by engineering specifications, material properties, and performance benchmarks established through industry standards and the predicate device's known performance. For example, a "burst" test would have a pre-defined pressure or force target that the device must withstand to pass.

8. The sample size for the training set:

• Not applicable. This concept is for machine learning models. These devices are physical products.

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

• Not applicable.

In summary, the provided FDA 510(k) summary is for physical medical devices and does not describe acceptance criteria or studies related to AI performance or human reader studies. The "studies" mentioned are non-clinical verification and validation tests to ensure the physical device meets its design specifications and is substantially equivalent to existing predicate devices.

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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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