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The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (S) located near the distal atraumatic soft tip (9).

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.

The shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock ( 1 ) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock (11) and pulling the pulling knob away from the handle (1). The inward-folding of the balloon forms a cavity and allows for collection and removal of embolic material.

The balloon size and diameter are printed on the strain relief (12). Refer also to the package label for information about catheter length, balloon nominal and rated burst pressure, balloon size, balloon compliance, guidewire compatibility and sheath compatibility.

The PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature underwent non-clinical bench testing to demonstrate its performance and safety, particularly regarding its use within a stent environment.

1. Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document states that "Sample sizes used for Design Verification and Validation testing were based on required confidence / reliability levels as a result of risk analysis performed for the PROTEUS™ PTA Balloon Catheter, or per recommendations within the FDA Guidance "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems." Specifically, the number of samples utilized for each test depended on whether the data to be collected was variable data or attribute data in nature." Specific numerical sample sizes for each test are not explicitly provided in the text.
• Data Provenance: The tests were non-clinical in vitro bench tests conducted by Angioslide, Ltd. No patient data (retrospective or prospective) from specific countries was used for these tests.

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

Not applicable. The study involved non-clinical bench testing, not human expert evaluation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The study involved non-clinical bench testing, not human expert review with adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This was a non-clinical bench test. No human readers or AI assistance were involved in evaluating efficacy.

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

Not applicable. This device is a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used:

In a non-clinical bench study for a physical device, "ground truth" is established by the specifications and measurable outcomes of the device's physical performance against predefined engineering and regulatory standards (e.g., burst pressure, inflation/deflation times, absence of leakage, ability to pass through a tortuous model). The "ground truth" is essentially the expected physical behavior and integrity of the device under simulated conditions.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device undergoing performance testing, not an AI model that requires a training set.

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

Not applicable. As this is not an AI model, there is no training set or ground truth for a training set in this context.

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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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