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The SmartClaw™ Thrombectomy Catheter is indicated for the non-surgical removal of thrombi and emboli from the peripheral vasculature.

The SmartClaw™ Thrombectomy Catheter is a mechanical thrombectomy catheter designed to work with commercially available sheaths sized 8F or larger. The device consists of an inner catheter shaft, outer catheter shaft, heat set nitinol braid, and an actuation handle attached to the proximal ends of the shafts. There are two device configurations that differ only in length of the expandable nitinol braided basket. The two configurations are identified by the maximum diameter of the expanded basket (20 mm, 32 mm).
The SmartClaw™ Thrombectomy Catheter is introduced through a commercially available sheath sized 8F or larger and delivered to the targeted vessel location under fluoroscopy and standard endovascular techniques using a commercially available guidewire. After it is delivered to the targeted vessel location, the catheter's distal nitinol basket is expanded by moving the handle slider proximally. Fluoroscopic guidance is used to ensure the expanded basket achieves a 1:1 ratio with the vessel diameter. Subsequently, the SmartClaw™ Thrombectomy Catheter is retracted proximally to pull loosened clot towards the sheath. Then, the clot is removed from the patient via aspiration or another commercially available clot removal method as appropriate for procedure requirements. After the clot is removed, the catheter's distal nitinol basket is collapsed, and the SmartClaw™ Thrombectomy Catheter is withdrawn from the targeted vessel location through the sheath.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "SmartClaw™ Thrombectomy Catheter." This type of document is a regulatory submission for a device that is substantially equivalent to a predicate device, meaning it's not a new groundbreaking technology, but rather a modification or similar version of an already cleared device.

Therefore, the document does not describe a study that would establish new acceptance criteria or prove device performance in a clinical setting in the way an AI/software device would. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and packaging validation).

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for an AI device study:

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

The document does not provide a table of acceptance criteria and reported clinical device performance in the way an AI study would (e.g., sensitivity, specificity, AUC). Instead, it discusses bench testing performance criteria.

The general statement for all bench tests is "The results of these tests demonstrate the subject device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing."

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

The document only mentions "performance evaluations" and "testing" for bench tests. It doesn't specify sample sizes for these tests, nor does it refer to "test sets" in the context of clinical data. Data provenance (country of origin, retrospective/prospective) is not applicable or provided as this is a physical device submission based on non-clinical data.

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

This information is not applicable as there is no clinical "test set" or "ground truth" derived from expert review in the context of an AI algorithm's performance. The "ground truth" for the non-clinical tests would be the established engineering specifications and standards.

4. Adjudication method for the test set

Not applicable, as there is no clinical test set requiring expert adjudication.

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 is a physical medical device (catheter) and not an AI/software device. Therefore, no MRMC study or AI assistance effect size is discussed.

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

Not applicable, as this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench testing, the "ground truth" would be the engineering specifications, design parameters, and relevant ISO standards (e.g., ISO 11607-1 and ISO 11607-2 for packaging).

8. The sample size for the training set

Not applicable, as this is not an AI algorithm.

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

Not applicable, as this is not an AI algorithm.

In summary:

This FDA 510(k) submission is for a physical medical device, not an AI software. The "study" referenced is a series of non-clinical bench tests and packaging validations, intended to demonstrate the device's physical integrity and functionality, and its substantial equivalence to a previously cleared predicate device. It does not involve patient data, clinical outcomes, or expert review for diagnostic accuracy, which would be typical for an AI/software device submission. The acceptance criteria are engineering and performance specifications, not clinical performance metrics like sensitivity or specificity.

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The WOLF Thrombectomy System, 14F is indicated for:
• The nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The WOLF Thrombectomy System, 14F is comprised of two single lumen variable stiffness catheters (WOLFcatheter & Devortex shaft) designed for use in removing clot from peripheral vessels. A funnel is attached to the distal end of the WOLF catheter to aid in ingestion of clot. The Devortex sleeve is attached to the Devortex shaft. When the Devortex shaft is pulled, it inqests the clot into the WOLF catheter. The WOLF catheter has hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot.

The Devortex shaft has one radiopaque marker band at the distal marker to indicate the tip of the catheter during tracking. The WOLF catheter has one radiopaque marker band at the base of the funnel to aid in positioning the funnel relative to the sheath during clot ingestion.

The WOLF Thrombectomy Sheath consists of a sheath, dilator and syringe. An active hemostatic valve is integrated at the proximal end of the sheath which can be manually opened for device introduction to provide hemostasis and minimize blood loss. The distal end of the sheath features a radiopaque marker forrecognition under fluoroscopy. The hemostasis valve is coupled with a large bore side port and is accompanied with a VacLok syringe for aspiration.

The provided document is a 510(k) summary for the WOLF Thrombectomy System, 14F. It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices through various performance tests. However, this document does not contain information related to an AI/ML device or its acceptance criteria and study results.

The document primarily focuses on the physical and mechanical properties of a medical device (a thrombectomy system) and its biocompatibility, sterilization, and packaging. It mentions "performance data" and "bench studies" that verify the device performs as intended with respect to its design inputs, including metrics like durability, integrity, kink resistance, and tensile strength. It also refers to "simulated use validation" and "animal testing" (primarily for the predicate device, with an acute study in an ovine model for radiopacity of the sheath).

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance for an AI/ML device, as the provided text is about a physical medical device and does not involve AI or ML.

If you have a document describing an AI/ML medical device and its validation studies, please provide that, and I would be happy to assist.

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The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.

The device is intended for single use only.

The WOLF Thrombectomy® System, 6F is comprised of two single lumen variable stiffness catheters (WOLF catheter & Devortex shaft) designed for use in removing clot from peripheral vasculature. The Devortex shaft is attached to the Devortex sleeve which when pulled, ingests the clot into the WOLF catheter. The WOLF Thrombectomy System, 6F is delivered through an access sheath that has an inner diameter of at least 0.087". Both the WOLF catheter and Devortex shaft have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The Devortex shaft has one radiopaque marker band to indicate the tip of the catheter during tracking. The WOLF catheter has a distal radiopaque marker band toindicate its distal tip during tracking and pulling. The Devortex sleeve also has a radiopaque polymer cuff that allows for visualization of the weave movement during use.

The provided text is a 510(k) premarket notification for the WOLF Thrombectomy® System, 6F. While it outlines the device's indications for use, technical characteristics, and performance data from bench studies and biocompatibility testing, it does not contain information about a study proving the device meets specific acceptance criteria related to its clinical performance or an AI/algorithm component.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for Use: The WOLF Thrombectomy® System, 6F is indicated for the non-surgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature. This is identical or very similar to the predicate devices.
• Technological Characteristics: Comparison tables show similarities in regulation, product code, FDA classification, common/classification name, intended use, and general design features. Differences, like the inclusion of reloads and the absence of funnels (due to the 6F device's target vessel size), are presented as not raising new safety or effectiveness concerns.
• Performance Data (Non-Clinical): Bench studies were conducted to confirm the device performs as intended, covering durability, integrity, kink resistance, torsion/tensile strength, leak testing, simulated use, coating integrity, particulate testing, and corrosion resistance. Sterilization, transit, package integrity, and shelf-life testing were also performed.
• Biocompatibility Testing: Extensive testing per ISO-10993-1 was conducted due to the addition of colorants and a manufacturing process change.
• Animal Testing: The document states that previous pre-clinical studies for the primary and secondary predicate devices support the safety and performance of the subject device, and animal testing was not repeated for the subject device.

Therefore, I cannot provide the requested information about acceptance criteria for clinical performance, an AI/algorithm component, or studies demonstrating such, because this information is not present in the provided 510(k) summary.

The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish de novo safety and effectiveness or specific performance metrics against clinical acceptance criteria. Had there been an AI component or a need for a clinical study to establish new performance claims, the submission would likely include an entirely different section detailing that evidence.

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The WOLF Thrombectomy V System is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.

The WOLF Thrombectomy V System is comprised of two single lumen composite, variable stiffness catheters. Both devices have a distal radiopague marker for recognition under fluoroscopy. The WOLF Outer device has a collapsible braided funnel formed at its distal end. The purpose of the funnel is to enable more efficient ingestion of clot in larger vessels. The system includes a preloaded weave and additional reloadable weave and reloadable weave are fabricated from fine nitinol wire formed into a desirable tubular shape and attached to the WOLF Inner Catheter. The end of both weaves that are not attached to the WOLF Inner Catheter are cuffed with a radiopaque polymer. The WOLF outer catheter has hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The WOLF inner catheter has one radiopaque marker band at the distal marker to indicate the tip of the catheter during tracking. The outer catheter has two sets of radiopague markers. The distal most marker bands reside in the distal end of the funnel to facilitate visualization of the second marker band is located at the base of the funnel to aid in positioning the funnel relative to the sheath during clot ingestion. The reloadable weaves can be used for additional clot removal. A WOLF Thrombectomy V System used with a reloadable weave has the same principle of operation of action as the system packaged with the preloaded weave.

The provided document is an FDA 510(k) clearance letter for the WOLF Thrombectomy V System. While it refers to performance data and animal testing, it does not contain the detailed information necessary to complete a table of acceptance criteria, specific reported performance metrics, or the methodologies for establishing ground truth for AI/ML device studies (e.g., number of experts, adjudication methods) as requested.

The document discusses:

• Device Description: The WOLF Thrombectomy V System is an embolectomy catheter for nonsurgical removal of emboli and thrombi from peripheral arterial and venous blood vessels.
• Substantial Equivalence: The submission demonstrates substantial equivalence to a predicate device (WOLF Thrombectomy Device, K182835) based on similar intended use, mechanism of action, components, construction, materials, and sterilization. It also used a reference device (Fogarty Venous Thrombectomy Catheter).
• Performance Data: States that bench studies indicate the device performs as intended and lists various types of testing performed (e.g., durability, sterility, shelf life, biocompatibility, simulated use, comparative performance analysis, animal testing).
• Animal Testing: Mentions acute and chronic animal studies were conducted to compare the safety of the WOLF device to a control device, assessing angiographic and histopathological outcomes. It states "The device passed all acceptance criteria outlined in the study protocol and should be deemed acceptable for clinical use," but does not specify those criteria or numerical results.

Essentially, this document summarizes that certain tests were done and passed, but it does not provide the specific details of those tests' acceptance criteria or the numerical results, nor does it describe a study involving an AI/ML component with human readers, training sets, or expert ground truth as typically required for AI/ML device clearances.

Therefore, I cannot populate the requested table and answer many of the questions because the information is not present in the provided text. The prompt asks for details related to an AI/ML device study, but the provided text describes a mechanical medical device (thrombectomy catheter) and its traditional 510(k) clearance process, which focuses on bench testing and animal studies for safety and performance of the physical device, not an AI/ML algorithm's analytical or clinical performance characteristics against a defined ground truth derived from expert consensus or pathology.

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