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The SpideRX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.

The provided text is a 510(k) summary for the SpideRX™ Embolic Protection Device. It describes the device, its intended use, and the FDA's substantial equivalence determination. However, the document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics typically found in clinical trials or validation studies.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SpideRX Embolic Protection Device K053195) based on the device description and intended use, particularly the modification to reflect compatibility with drug-eluting stents.

Therefore, I cannot provide the requested table and study details as they are not present in the input text.

To directly answer your numbered points based on the provided text's limitations:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text.
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 provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
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 relevant to this device, as it is a physical medical device (embolic protection system), not an AI-assisted diagnostic tool. No such study information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an algorithm or AI device. No such study information is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the text. The 510(k) process for this type of device typically relies on bench testing, animal studies, and clinical data showing safety and effectiveness comparable to a predicate, but specifics are not in this summary.
8. The sample size for the training set: Not applicable/not provided. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable/not provided. This is a physical device, not a machine learning model.

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The SpideRX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.

The provided 510(k) summary describes the SpideRX™ Embolic Protection Device and its evaluation for substantial equivalence to predicate devices. It states that the device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) and also acts as a guidewire during percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The SpideRX Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

The SpideRX Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance based on the clinical study. Instead, the study's conclusion is that the "differences observed between the primary endpoint event rates were not statistically significant," which "demonstrates the safety and performance of the SpideRX Device for its intended use." This implies that the acceptance criterion was likely non-inferiority to predicate devices or a pre-defined acceptable complication rate, which was met.

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

• Test Set Sample Size: Not explicitly stated. The study is described as a "non-randomized multi-center registry study."
• Data Provenance: Not explicitly stated, but "multi-center registry study" suggests data from multiple clinical sites, likely within the country where the trial was conducted (presumably the US, given the FDA submission). It is a prospective clinical study, as it was performed to assess the safety and performance of the device when used with another system.

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

This information is not provided in the document. The clinical study assessed "safety and performance," which would involve clinical outcomes and event rates, but the method for establishing "ground truth" (e.g., assessing the nature of embolic material, or specific clinical outcomes via independent review) is not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a "non-randomized multi-center registry study" focused on the safety and performance of the SpideRX device, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This is not applicable as the SpideRX Embolic Protection Device is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used:

The ground truth for the clinical study was based on clinical outcomes/events related to safety and performance (e.g., embolic events, complications, successful deployment/retrieval). The document doesn't specify how these events were formally adjudicated or categorized as "ground truth," but it would typically involve clinical assessments and potentially imaging. It does not mention pathology or outcomes data in the sense of long-term follow-up beyond the immediate procedural context being assessed.

8. Sample Size for the Training Set:

This is not applicable. The SpideRX Embolic Protection Device is a physical medical device; thus, there is no "training set" in the context of machine learning or AI. The term "training set" is generally used for algorithms that learn from data.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable, as there is no "training set" for a physical medical device.

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