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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 containment of embolic material 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 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 ( 1 l ) and pulling the pulling knob away from the handle (1). The embolic capture feature involves a single-use suction mechanism that works through inward folding of the balloon, which creates negative pressure within the capture cavity for debris capture and removal. The reduced pressure in the capture cavity causes some of the particles that are released during the procedure to flow into the cavity for containment and removal. 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.

Here's a breakdown of the acceptance criteria and the study information for the PROTEUS™ PTA Catheter with Embolic Capture Feature, based on the provided text:

Acceptance Criteria and Device Performance

The device underwent extensive non-clinical bench testing, sterilization, packaging, and shelf-life testing to demonstrate conformance. The table below summarizes the acceptance criteria and reported device performance for these non-clinical tests.

Note: The provided document is a 510(k) summary for a submission that claims substantial equivalence to a predicate device (K111750), implying that the new device has identical technological characteristics for both PTA balloon function and embolic capture. Therefore, the "study" described here is a suite of design verification and validation tests rather than a comparative clinical trial.

Study Details for PROTEUS™ PTA Catheter

Based on the provided K120164 510(k) summary, the "study" refers to a series of non-clinical bench tests for design verification and validation, as well as tests for biocompatibility, sterilization, packaging, pyrogenicity, and shelf life. This is a 510(k) submission, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for effectiveness.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: The sample sizes 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 varied depending on whether the data was variable or attribute.
     • For the "four corners" approach, at least four sizes (largest/smallest diameters and lengths) plus a middle catheter size were tested for robustness.
     • Many tests specify a confidence/reliability level (e.g., 90% Conf., 90% Rel. or 95% Conf., 90% Rel.), which dictates the minimum sample size for attribute or variable data.
   • Data Provenance: The tests were "in vitro bench testing" conducted by Angioslide, Ltd., an Israeli company. The data is prospective, generated specifically for this submission. The origin of the data itself is from laboratory bench tests.

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

   • This document describes bench testing of a medical device's physical and functional characteristics, not an AI or diagnostic device that requires expert ground truth. Therefore, no experts (e.g., radiologists) were used to establish ground truth in the traditional sense of medical image interpretation or diagnosis. The "ground truth" for these tests are the pre-defined engineering specifications and performance standards outlined in the acceptance criteria.

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

   • Not applicable. This is not a study requiring adjudication of clinical or image-based findings. The results of the bench tests (e.g., whether a dimension is "in tolerance" or if "no leakage" is observed) are direct physical measurements and observations against pre-defined criteria.

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:

   • No. This is a medical device (PTA Catheter) and not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance was involved.

5. 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 or AI system.

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

   • For the bench tests, the "ground truth" is defined by engineering specifications, regulatory standards (e.g., ISO, FDA guidance documents), and internal design requirements. For example, "In Tolerance" for a dimension, "No Leakage" for a seal, "Force at Break ≥ 10N" for tensile strength. For pyrogenicity, it's a specific endotoxin limit (0.5 EU/ml).

7. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device that requires a training set. The "training" for this device would be its manufacturing process and design iterations, not data sets for an algorithm.

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

   • Not applicable, as there is no training set mentioned or implied for this type of device.

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