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The F.A.S.T.™ System SED and CXD are indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• The non-surgical removal of thrombi from synthetic grafts.
• Temporary use in vessel/graft occlusions.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft.
• Catheter placement over a guidewire.

The F.A.S.T.™ System - SED (Self-Expanding Device) and F.A.S.T.™ System - CXD (Controlled Expansion Device) are sterile, disposable, thrombectomy systems for the non-surgical removal of emboli and thrombi from blood vessels or grafts.

The F.A.S.T.™ System -- SED consists of a self-expanding nitinol basket mounted on a core wire. The device is compressed and sheathed in an introducer designed to facilitate loading and advancement of the device into the proximal hub of an 0.021-in (0.533-mm) microcatheter. When advanced to the distal end of a microcatheter, the compressed basket is deployed by withdrawing the microcatheter over the basket may be reconstrained back into the microcatheter.

The F.A.S.T.™ System - CXD Device consists of an expandable nitinol basket mounted on a hollow tube and core wire. Basket expansion and contraction to the desired diameter is controlled by the operator at the proximal end of the device. Using the handle control, the basket is contracted prior to withdrawing the device back into the microcatheter.

Both the F.A.S.T.™ System - SED and the F.A.S.T.TM System - CXD have markers at the proximal and distal ends of the basket to facilitate visualization under fluoroscopy and are compatible with 0.021 inch (0.533-mm) inner diameter (ID) microcatheters.

This is a 510(k) summary for a medical device (F.A.S.T.™ System SED and CXD) seeking substantial equivalence to a predicate device. As such, it does not typically include detailed performance criteria and specific study results (like sensitivity, specificity, AUC) that would be found in a clinical trial report for novel devices or AI/ML-driven diagnostics. The goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, often by showing similar technological characteristics and performance through non-clinical testing.

Therefore, many of the requested elements (e.g., specific performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications, MRMC studies, specific ground truth methods) are not typically present in this type of regulatory document.

However, based on the provided text, here's what can be extracted and inferred:

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

The document doesn't provide a table of quantitative acceptance criteria with specific numerical targets (e.g., "sensitivity > X%"). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device and showing "adequate device performance" through "verification testing."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the document. The testing mentioned is "in-vitro and in-vivo testing" and "verification testing," which typically involves engineering or bench testing and potentially animal studies for medical devices like this, rather than a clinical "test set" of patient data as understood in AI/ML.
• Data Provenance: Not specified. Given it's a technical verification of a device, the data origin would likely be laboratory or animal studies, not patient data in terms of "country of origin."
• Retrospective or Prospective: Not applicable in the context of device verification testing described here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a thrombectomy catheter for mechanical removal of clots, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment on a test set. The validation would involve performance against engineering specifications and potentially clinical outcomes in animal models, not expert consensus on image interpretation.

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

Not applicable. No mention of expert adjudication for a "test set" in the context of this device's validation.

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 device is a mechanical thrombectomy system, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.

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

Not applicable. This device is a physical medical instrument, not an algorithm. Its operation inherently involves a human operator (e.g., a physician).

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

The document refers to "in-vitro and in-vivo testing" (Page 5, Section VIII). For medical devices like this, "ground truth" for performance would be established through:

• In-vitro: Bench testing against predetermined engineering specifications (e.g., thrombectomy efficacy in a simulated vessel model, catheter steerability, basket deployment/retraction, material strength, flow rates).
• In-vivo: Animal studies to assess device safety and performance characteristics in a living system (e.g., ability to remove thrombi, impact on vessel walls, patency).
• Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is demonstrating that the device performs at least as well as and shares fundamental characteristics with the legally marketed predicate device, without raising new safety or effectiveness concerns.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for this type of device.

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The Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/ Suction Thrombectomy) System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels. .
• . The non-surgical removal of thrombi from synthetic grafts.
• . Use in temporary blood vessel/graft occlusion.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a ● vessel/graft.
• . Catheter placement over a guidewire.

The Genesis Medical Interventional™ F.A.S.T.TM (Facilitated Aspiration/Suction Thrombectomy) System is comprised of the following main components:

• Expanding Basket Thrombectomy Guidewire; .
• Funnel Sheath Catheter; .
• Dilator:
• . Funnel Sheath Catheter/Dilator assembly Tip Cover
• Accessories 18 gauge needle and vacuum syringe. .

The provided document is a 510(k) summary for the Genesis Medical Interventional™ F.A.S.T.™ System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a de novo study with acceptance criteria and performance metrics in the way a new, high-risk device might.

Therefore, the specific information requested about acceptance criteria, detailed performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory submission for this device.

Here's an explanation based on the provided text:

• Type of Device and Approval Process: The F.A.S.T.™ System is an "Embolectomy Catheter" (Product Code: DXE), a Class II device. Its approval is via the 510(k) pathway, which means it seeks substantial equivalence to already legally marketed predicate devices. This process primarily involves demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.

• "Study" Described: The study mentioned is a comparison to predicate devices to demonstrate substantial equivalence. The document states: "Performance data was provided to demonstrate that the Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/Suction Thrombectomy) System components perform in accordance with their specifications." This usually refers to internal verification and validation testing to ensure the device meets its own design specifications, and that these specifications are comparable to or better than those of the predicate devices. It does not typically involve clinical trials or studies with specific performance metrics like sensitivity, specificity, or reader improvement, as would be seen for AI/ML devices or novel high-risk devices.

Here's a breakdown of the requested information, indicating why it's not available in this document:

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

• Not present. The document states "Performance data was provided to demonstrate that the ... System components perform in accordance with their specifications." However, it does not enumerate these specifications or present formal acceptance criteria with corresponding performance results in a table. For a 510(k) substantial equivalence submission, the primary "acceptance criterion" is often that the device performs equivalently to the predicate devices across relevant functional parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not present. There is no mention of a "test set" in the context of clinical data or patient outcomes. The "performance data" likely refers to bench testing, engineering validation, and possibly animal studies, not human clinical trials with a defined sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not present. This type of information is pertinent to studies involving human interpretation or clinical outcomes, which are not detailed here.

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

• Not present. As there's no described "test set" for expert review, adjudication methods are not applicable nor mentioned.

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 present. This document is for a mechanical medical device (a catheter for thrombectomy), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human reader improvement with AI" are entirely irrelevant and not mentioned.

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

• Not present. This applies to algorithms, not mechanical devices.

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

• Not present. The "ground truth" for a device like this would typically be its ability to physically remove thrombi in controlled (often in vitro or in vivo animal) environments, or its mechanical integrity and functional performance against engineering specifications. No specific type of ground truth data (like pathology or outcomes) is detailed from a clinical study.

8. The sample size for the training set

• Not present. This concept is for AI/ML models.

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

• Not present. This concept is for AI/ML models.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" of a medical device to existing predicate devices. It does not contain the kind of detailed performance study data, acceptance criteria, or clinical trial information that would be found for a novel device undergoing a de novo classification or a more extensive clinical validation. The "performance data" referred to is almost certainly verification and validation testing against engineering specifications, not clinical outcomes from human subjects.

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