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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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