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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

Note: The acceptance criteria are implicitly defined by the non-inferiority hypothesis, where the SpideRX device is considered non-inferior if the MACE rate difference from the control group is statistically significantly less than 5.5%.

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

• Sample Size (Randomized Portion):
  • SpideRX/Treatment Arm: 383 patients
  • Control Arm: 364 patients (FilterWire EX™ Embolic Protection System, FilterWire EZ™ Embolic Protection System, or GuardWire® Plus Temporary Occlusion and Aspiration System)
  • Total Randomized: 747 patients
• Data Provenance: The study was a "prospective, randomized, multi-center trial." The specific country of origin is not mentioned, but "multi-center" implies multiple locations, likely within the US, given the FDA submission.

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

The document does not mention the use of experts to establish ground truth for the test set in the context of diagnostic performance or image interpretation. The primary endpoint, 30-day MACE (Major Adverse Cardiac Events), including death, myocardial infarctions (MI), target vessel revascularizations, and emergent CABG (Coronary Artery Bypass Graft) procedures, are clinical outcomes rather than expert-interpreted data points. Myocardial infarctions are determined through lab tests (CK-MB results).

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method for the events contributing to the 30-day MACE. However, the nature of clinical endpoints like death, MI (based on biomarkers), and revascularization often involves standardized definitions and potentially an independent clinical events committee for adjudication in a multi-center trial, though this is not explicitly detailed here. The discussion on missing CK-MB data and its statistical imputation suggests a rigorous approach to handling data, but not an "adjudication method" in the sense of reconciling expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This study is evaluating the clinical efficacy and safety of an embolic protection device, not a diagnostic AI system or an assistance tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No, a standalone algorithm performance study was not done, as this evaluates a medical device (embolic protection device), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was clinical outcomes data, specifically the 30-day Major Adverse Cardiac Events (MACE), which includes:

• Death
• Myocardial Infarction (defined by CK-MB levels where possible)
• Target Vessel Revascularizations
• Emergent CABG procedures

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI or algorithm development. The entire study cohort (963 total enrolled patients, 747 in the randomized portion) constitutes the clinical trial data used to evaluate the device. If an internal analysis or model was created to impute missing CK-MB data, it would have been trained on data from within the SPIDER trial that had complete CK-MB values, but this is not a "training set" for the device itself.

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

As no training set for an AI/algorithm was identified, this question is not applicable. The clinical outcomes that served as the "ground truth" for the device's evaluation (MACE) were established using standard clinical definitions and measurements (e.g., CK-MB for MI, clinical events for death, revascularization).

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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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