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The Angioslide eXtraTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral translyminal angioplasty and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

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

The Angioslide eXtra™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is a single-use disposable over-the-wire co-axial dual lumen catheter with a foldable balloon near the distal tip. The balloon catheter consists of the balloon located near the distal atraumatic soft tip, the telescopic shaft and the handle.

One lumen is used for inflation of the balloon and is accessed via the inflation port. The other lumen, starting at the quidewire port. allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopague markers 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 comprises the outer shaft and the inner shaft. The distal end of the balloon is connected to the inner shaft and the proximal end of the balloon is connected to the outer shaft. The inner shaft is connected to the pulling rod and the outer shaft is connected to the handle body. The pulling rod lock locks the handle body and the pulling rod together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by unlocking the pulling rod lock counter-clockwise and retracting the pulling rod. The inward-folding of the balloon forms a cavity and allows for collection of embolic material.

Here's an analysis of the Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature based on the provided 510(k) summary, focusing on acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly lay out a table of acceptance criteria with corresponding performance metrics from the studies for the device itself in a quantitative manner. Instead, the document describes the types of tests performed and states that the "results of the MC-LEADER and MC-LEADER Supplemental Studies met performance goals derived from historical literature describing PTA performance." For the animal study, it states: "The results of this study demonstrated that the safety and performance of the Angioslide eXtra™ PTA Balloon Catheter was substantially equivalent to that of the control article when used in an in vivo model."

However, based on the identified endpoints from the clinical studies, we can infer the performance goals the device aimed to meet:

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

The raw sample sizes for the clinical studies are not explicitly stated. However, the document mentions:

• MC-LEADER Study: Unspecified number of patients, conducted at three centers outside of the US.
• MC-LEADER Supplemental Study: Unspecified number of patients, conducted at two centers outside of the US.

Both clinical studies were described as:

• Prospective
• Multi-center
• Non-randomized
• Single-arm

The animal study:

• Chronic GLP study
• Used an "in vivo porcine model." The exact number of animals is not specified.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the clinical studies. For the animal study, it mentions:

• Study pathologist: Assessed safety via gross and microscopic evaluation post-procedure.
• Investigators: Assessed functional performance during PTA and post-stent dilation.
  No further details on the qualifications or number of these individuals are given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication methods (e.g., 2+1, 3+1) for the clinical or animal studies.

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

No, an MRMC comparative effectiveness study was not done. The clinical studies were single-arm studies focused on the performance of the Angioslide eXtra™ device itself, and the animal study compared it to a control device in an in vivo model. There is no mention of human readers or AI assistance in the context of effectiveness studies.

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

This device is a physical medical device (balloon catheter), not an AI algorithm. Therefore, the concept of a "standalone algorithm only" performance study is not applicable.

7. The Type of Ground Truth Used

• Clinical Studies: The ground truth for the clinical studies involved a combination of:
  • Clinical Outcomes Data: Acute device success, acute procedural success (<50% residual stenosis), adverse event rates, clinical success at 30 days (ABI and RB improvement), target vessel revascularization at 12 months, serious adverse event rate, acute distal embolization rate. These are directly observed and measured clinical endpoints.
• Animal Study: The ground truth for the animal study involved:
  • Pathology: Gross and microscopic evaluation post-procedure by a study pathologist.
  • Functional Performance Assessment: By investigators during PTA and post-stent dilation.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is a physical medical device and not an AI/ML algorithm. The document describes pre-clinical (bench and animal) testing and clinical studies to evaluate the safety and performance of the device.

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

As stated above, a training set is not applicable for this type of device. The ground truth for the evaluations (bench, animal, clinical) was established through the various testing methodologies and clinical endpoints outlined.

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