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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 is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide PROTEUSTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) 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 (11) 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 provided document describes the Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature. It is a medical device designed for peripheral transluminal angioplasty and for capturing embolic material during angioplasty in various peripheral arteries. The document is a 510(k) summary, demonstrating substantial equivalence to a predicate device (K133043).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comprehensive table of non-clinical bench tests. All tests passed, indicating the device met its acceptance criteria. Below is a summarized version of the table provided in the document:

2. Sample size used for the test set and the data provenance

• Sample Size: "Sample sizes used for the testing were based on required confidence/reliability levels as per FDA Guidance... and the results of the risk analysis (DFMEA). The number of units utilized for each test depends on whether the data to be collected was variable data or attribute data, therefore the number of units tested varies from test to test. However, in all cases, the number utilized for testing met the required number of units based on the risk analysis, and the required confidence/reliability levels."
• Data Provenance: The studies are described as "In vitro bench testing" and "Design Verification and Validation," performed in accordance with Angioslide's Risk Analysis and applicable FDA Guidance documents and ISO standards. This indicates the testing was conducted in a laboratory setting, likely at the manufacturer's facility in Israel. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is not an AI/imaging device requiring expert interpretation of medical images to establish ground truth. The acceptance criteria are based on objective, quantifiable physical and mechanical properties of the device, measured using standardized engineering and material science tests. Therefore, there are no "experts" in the traditional sense of medical image interpretation for a test set, nor are there qualifications of such experts relevant to the type of testing performed. The "ground truth" is established by the specifications defined in the design and validated through these bench tests against established industry standards (ISO, FDA guidance).

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

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests conducted are objective, measurable physical and mechanical tests of the device's components and functionality.

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 applicable. This device is a physical medical device (a balloon catheter), not an artificial intelligence (AI) or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

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, not an algorithm. The testing described is for the physical and functional aspects of the catheter itself.

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

The "ground truth" for this device's performance is established by engineering specifications, industry standards (ISO), and FDA guidance documents. For example, the definition of "In Tolerance" for dimensions or "No leakage" for liquid leakage comes from predetermined, objective criteria. For the purpose of substantial equivalence, the performance is compared against these predefined physical and functional benchmarks, rather than clinical outcomes or expert consensus on medical findings.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set. The device is a physical medical instrument.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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