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The ClotTriever Thrombectomy System is indicated for:
• The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over-the-wire catheter-based system used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system consists of ClotTriever Catheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately. The ClotTriever Sheath consist of a polymeric shaft with a distal self-expanding nitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing. The mesh funnel is deployed by retracting the slide actuator back until it snaps into place. The mesh funnel self-expands to the diameter of the vessel and serves as a backstop as clot is removed through the lumen of the sheath. A hemostasis valve is integrated into the proximal hub of the sheath to prevent blood loss from devices passing through it. The sideport tubing has a large-bore stopcock and a terminal quick-disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspiration of clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the target vessel prior to sheath insertion. A dilator is provided to aid insertion and positioning of the sheath, while the loading tool facilitates insertion of the mesh funnel into the dilator.

Here's an analysis of the provided FDA 510(k) summary regarding the ClotTriever Sheath, focusing on "acceptance criteria" and "study that proves the device meets the acceptance criteria."

Important Note: The provided document is a 510(k) clearance letter and summary for a medical device (ClotTriever Sheath). It is not a typical AI/Software as a Medical Device (SaMD) submission that would involve performance metrics like sensitivity, specificity, AUC, or a comparative effectiveness study with human readers assisting AI. Therefore, most of the requested information (sample size for test set, expert qualifications, MRMC study, standalone performance, training set details) will either be explicitly stated as "not applicable" or inferred from the nature of the device submission.

The "device" in this context is a physical medical device (catheter sheath), not an AI algorithm. The "acceptance criteria" and "performance" relate to its physical and functional characteristics, and its "study" refers to non-clinical (bench) testing, not clinical trials with human readers or AI algorithms.

Acceptance Criteria and Device Performance for ClotTriever Sheath

The acceptance criteria for the ClotTriever Sheath, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to a predicate device (Protrieve Sheath) through non-clinical performance characteristics, and the safety and effectiveness of the device for its indicated uses.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device and not an AI algorithm, the "acceptance criteria" are typically defined by engineering specifications, material properties, and functional performance benchmarks to ensure safety and effectiveness for its intended use. The "reported device performance" is demonstrated through verification testing.

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

• Sample Size: Not applicable. For a physical device like a sheath, the "test set" would typically refer to the number of devices or components tested during non-clinical verification. This number is not specified in the provided summary, as it's typically found in detailed test reports, not the 510(k) summary itself. The summary only refers to "Verification testing provided in K180329 and K192036."
• Data Provenance: Not applicable in the context of human data. The testing mentioned in the previous 510(k)s (K180329 and K192036) would be non-clinical (bench and potentially animal) testing.

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

• Not applicable. This submission is for a physical medical device, not an AI/SaMD. "Ground truth" in this context refers to engineering specifications and performance benchmarks, not expert annotations of medical images or data.

4. Adjudication Method for the Test Set

• Not applicable. This relates to expert review for AI/SaMD and is not relevant for this physical device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size (e.g., human readers improve with AI vs without AI assistance)

• No, not applicable. This is a physical device, not an AI-assisted diagnostic tool.

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

• No, not applicable. This is a physical device, not a standalone algorithm.

7. The Type of Ground Truth Used

• Engineering specifications and documented performance characteristics. For medical devices, the "ground truth" for non-clinical testing refers to established engineering standards, material properties, functional requirements, and safety benchmarks (e.g., burst pressure, tensile strength, flow rates, biocompatibility results), along with performance observed in simulated-use environments (e.g., flow models). The comparison to the predicate device also establishes a "ground truth" of already cleared and accepted performance.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/Machine Learning device.

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

• Not applicable. There is no "training set" as this is not an AI/Machine Learning device.

In summary, this 510(k) pertains to a non-active, physical medical device (catheter sheath). The "acceptance criteria" and "proof" primarily stem from demonstrating substantial equivalence to a legally marketed predicate device (Protrieve Sheath) based on shared intended use, similar technological characteristics, and prior non-clinical verification testing, without raising new questions of safety or effectiveness. The questions about AI-specific validation metrics are not applicable here.

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The ClotTriever Thrombectomy System is indicated for:

• The non-surgical removal of soft thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.

The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System is comprised of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter consists of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.

This document describes the ClotTriever Thrombectomy System, a medical device for removing thrombi and emboli from blood vessels. However, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm performance study.

The document is a 510(k) premarket notification summary for an updated version of the ClotTriever Thrombectomy System, comparing it to a previously cleared predicate device. The "acceptance criteria" discussed are related to non-clinical engineering and material tests to demonstrate that the modified physical device is substantially equivalent to the predicate device, not performance benchmarks for an AI or algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets those criteria, as well as the related details (sample size, experts, adjudication, MRMC, standalone, ground truth, training set details) because this information is not present in the provided text.

The "Non-Clinical Testing" section explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This further confirms that no human-centric performance study (like an AI study would entail) was conducted or presented in this 510(k) submission.

Summary of what can be extracted regarding "acceptance criteria" and "study" for this physical device:

• Acceptance Criteria and Reported Device Performance (Table): Not directly available in a table format for performance in the AI sense. The text mentions "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use." The types of non-clinical tests that presumably had acceptance criteria are listed:
  • Visual & Dimensional Inspections
  • Guidewire Compatibility
  • Tensile testing
  • Test Conical Fittings with 6% Luer taper
  • (No specific performance metrics are given, only that criteria were met).
• Sample size for the test set and data provenance: N/A for an AI/algorithm study. The "test set" here refers to the physical devices manufactured for non-clinical testing, not a dataset of patient images.
• Number of experts used to establish ground truth & qualifications: N/A. Ground truth for these physical tests would be engineering specifications and measurements.
• Adjudication method: N/A.
• MRMC comparative effectiveness study: No. "Clinical testing was not required."
• Standalone (algorithm only without human-in-the-loop performance): No, this is for a physical medical device.
• Type of ground truth used: For the physical device, ground truth would be engineering specifications, material standards, and physical measurements.
• Sample size for the training set: N/A.
• How the ground truth for the training set was established: N/A.

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The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Thrombectomy System is indicated for:

• · The non-surgical removal of soft thrombi and emboli from blood vessels.
• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.

The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port with tubing clamp, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include a clot reservoir, a flush port adapter, an aspiration insert, funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque, and radiopaque marker bands are located on the coring element shaft at the proximal end of the expandable coring element, and at the distal ends of the ClotTriever Sheath and ClotTriever Catheter outer shaft.

The prompt asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text. However, the provided text does not contain details about specific acceptance criteria (e.g., numerical thresholds for performance metrics) or a study with detailed results that explicitly "prove" the device meets these criteria. Instead, it describes non-clinical testing performed to establish substantial equivalence to a predicate device.

Therefore, many of the requested details cannot be extracted directly from the provided document. I will answer based on what is available, and explicitly state when information is missing.

Here's the breakdown of what can be inferred/extracted:

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

The document lists various non-clinical tests conducted but does not provide a table with specific acceptance criteria (e.g., "Deployment Force

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