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The SpiderFX Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material in conjunction with the TurboHawk, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities.

The SpiderFX® Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 320/190 cm PTFE-coated 0.014" stainless steel guidewire and a dualended SpiderFX Catheter for delivery and recovery. The SpiderFX® Embolic Protection Device uses the following materials: pebax, grilamid, platinum/iridium, nitinol, stainless steel, PTFE coating, gold tungsten, and hydrophilic coating.

Here's a breakdown of the acceptance criteria and study information for the SpiderFX® Embolic Protection Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

Clinical Study (DEFINITIVE Cat+)

1. Sample size used for the test set and data provenance:

   • Sample Size: 131 subjects.
   • Data Provenance: Prospective, multi-center, non-randomized, single-arm study. The country of origin is not explicitly stated, but it's typically a multi-national or US-based study for FDA submissions. The study involved comparison to a performance goal derived from an observational multi-center registry (TALON).

2. 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):

   • Number of Experts: Not explicitly stated, but a "clinical events committee (CEC)" was used for adjudication. Specific number and qualifications are not provided in this summary.

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

   • Adjudication Method: "as adjudicated by the clinical events committee (CEC)". The specific method (e.g., majority vote, consensus) for the CEC is not detailed.

4. 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:

   • MRMC Study: No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This was a clinical study evaluating the device's safety and effectiveness.

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

   • Standalone Performance: Not applicable. This device is a physical embolic protection system, not an AI algorithm.

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

   • Ground Truth: For the primary safety endpoint, the "ground truth" was defined by the occurrence of Major Adverse Events (MAE) through 30 days post-procedure, as adjudicated by a Clinical Events Committee (CEC). This is essentially outcomes data, interpreted and confirmed by expert consensus within the CEC.

7. The sample size for the training set:

   • Training Set Sample Size: Since this is a physical medical device and not an AI algorithm, there isn't a "training set" in the conventional machine learning sense for the clinical study. The study population of 131 subjects served as the test set for the device's performance.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth Establishment: Not applicable, as there is no traditional "training set" for an AI model.

Pre-Clinical Performance Testing

For the extensive list of performance tests (Stent Compatibility, Filter Efficiency, Radial Outward Force, Simulated Use, Deployment/Retrieval Forces, In Vivo Animal Studies, Embolic Capture Efficiency and Retrieval Ability, Filter Capacity, Resistance to Filter Rupture During Removal of a Fully Loaded Filter, Flow Characteristics, Tip Flexibility, Tensile Strength, Torque Strength, Torque Response, Kink Resistance, Dimensional Verification, Package Integrity, Sterilization, Shelf Life):

• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone, Ground Truth Type, Training Set: These details are not provided in the 510(k) summary for these specific pre-clinical tests. They are generally performed by engineers and technicians according to validated test methods, and the "ground truth" is typically the measured physical properties and performance against pre-defined engineering specifications or industry standards. The summary indicates that "Test results met the specified acceptance criteria" for these tests, leveraging data from predicate device submissions (K063204 or K052659).

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

Acceptance Criteria and Device Performance for SpiderFXTM Embolic Protection Device

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantatitive acceptance criteria for the SpiderFX™ device. Instead, the study's goal was to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" can be inferred as achieving equivalence to the predicate device's performance in various tests.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not specify exact sample sizes for the "in vitro bench testing," "package integrity testing," or "in vivo animal studies." It only generally states that these tests were conducted.
• Data Provenance: The studies were non-clinical, involving in vitro bench testing and in vivo animal studies. The country of origin for the data is not specified, but the manufacturer is based in Plymouth, MN, USA. The data is implicitly prospective as it was generated to support the 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: This information is not provided in the text.
• Qualifications of Experts: This information is not provided in the text.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Since the studies were non-clinical bench and animal tests, the concept of expert adjudication as used in clinical imaging studies would not typically apply.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The device is a physical medical device (embolic protection device), not an AI algorithm for diagnostic imaging that typically involves MRMC studies to assess human reader improvement.

6. Standalone (Algorithm Only) Performance Study

This question is not applicable as the SpiderFX™ Embolic Protection Device is a physical medical device, not a standalone algorithm.

7. Type of Ground Truth Used

For the non-clinical studies:

• In vitro bench testing: The ground truth would be based on physical and engineering measurements against predefined specifications or comparative performance with the predicate device.
• In vivo animal studies: The ground truth would be established through direct observation, animal physiological measurements, and potentially necropsy results to evaluate the device's ability to contain and remove embolic material, as well as its safety.

8. Sample Size for the Training Set

This question is not applicable. The SpiderFX™ Embolic Protection Device is a physical medical device. It does not employ machine learning or AI that would require a "training set" in the conventional sense. The development of the device would involve engineering design, prototyping, and iterative testing, not data-driven training of an algorithm.

9. How Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons stated in point 8.

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

The provided text describes the SpiderFXTM Embolic Protection Device and its 510(k) summary (K063204). However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria with reported performance metrics, expert involvement, or statistical details.

The document states that:

• "Non-clinical verification and validation of the SpiderFX™ Embolic Protection Device consisted of in vitro bench testing, package integrity testing, and in vivo animal studies. Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use."
• The device is "substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K052659) in intended use, materials, technological characteristics and performance."

This indicates that the acceptance criteria and proof of performance were likely evaluated by demonstrating equivalence to the predicate device (SpideRX™ K052659) through these non-clinical tests. The K063204 document serves as the FDA's acceptance of this substantial equivalence, not as a detailed report of the underlying studies.

Therefore, for the specific questions asked, most of the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that "Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use," but it does not present specific quantitative acceptance criteria or corresponding device performance results (e.g., capture efficiency, deployment success rates, etc.).

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

Not available in the provided text. The document mentions "in vitro bench testing" and "in vivo animal studies" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective nature).

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

Not available in the provided text. The verification and validation involved non-clinical studies (bench and animal), not human expert-read test sets in the context of diagnostic or interpretive devices.

4. Adjudication Method for the Test Set

Not applicable/Not available in the provided text. This usually applies to studies involving human interpretation or performance on images/data, which is not described here for the non-clinical tests.

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

Not applicable. This device is an embolic protection device, not an AI-based diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to its evaluation.

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

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its mechanical design and function. While bench and animal tests evaluate its standalone physical performance, it's not "algorithm only" in the sense of AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not explicitly stated in detail. For "in vitro bench testing," the ground truth would be established by the test parameters themselves (e.g., known particle sizes for filtration, known forces for mechanical integrity). For "in vivo animal studies," the ground truth would typically refer to outcomes observed in the animal model (e.g., prevention of emboli, vessel patency, tissue damage).

8. The Sample Size for the Training Set

Not applicable/Not available in the provided text. This device is not an AI algorithm that requires a training set.

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

Not applicable/Not available in the provided text. This device is not an AI algorithm that requires a training set.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device through non-clinical testing (bench and animal studies), rather than detailing specific clinical trial data with acceptance criteria and performance metrics in the format requested for a typical AI/diagnostic device study.

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