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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 PROTEUS™ PTA Balloon Catheter with Embolic Capture is an over the wire coaxial dual lumen catheter with a foldable balloon located near the distal atraumatic soft tip.

The PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature consists of a foldable balloon with radiopaque markers which aid in positioning the balloon in the artery during the angioplasty procedure, the co-axial shaft comprising the inner shaft and the outer shaft, and the handle comprising the handle enclosure, the T-connector, the inflation port, the pulling rod with the guidewire port, and the pulling rod locks.

Following embolic capture, the user can opt to use the PROTEUS™ Particle Visualization Kit (PVK) to facilitate the visualization of the embolic material captured by the PROTEUS™ PTA Balloon Catheter.

The provided text describes a Special 510(k) submission for the PROTEUS™ PTA Catheter with Embolic Capture Feature. This submission is for modifications to an already cleared device, specifically the addition of a Particle Visualization Kit (PVK) accessory.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria or provide a table of reported device performance in terms of metrics like sensitivity, specificity, accuracy, etc. This is common for Special 510(k) submissions focusing on modifications, especially when the modification is an accessory and the core function (embolic capture) of the device remains identical to a predicate.

The primary "acceptance criterion" implied throughout is substantial equivalence to the predicate device (Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature K090364) in terms of indications for use, technological characteristics, and performance characteristics.

The document states:

• "The balloon technological characteristics of the modified version of PROTEUS™ PTA Balloon Catheter are substantially equivalent to those of the unmodified version of the device."
• "The modified PROTEUSTM PTA Balloon Catheter overall length, catheter sheath sizing, balloon diameter, balloon length, balloon nominal pressure, balloon rated burst pressure and end hole diameter are identical to the unmodified version of the device."
• "The embolic capture technological characteristics of the modified PROTEUSTM PTA Balloon Catheter are identical to those of the unmodified version of the device."

The only specific testing mentioned relates to the new accessory:

• "Verification and validation testing of the PROTEUS™ Particle Visualization Kit included simulated use testing."

Without specific metrics or quantitative data from this simulated use testing, a formal table cannot be constructed.

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

• Test Set Sample Size: The document mentions "simulated use testing" for the Particle Visualization Kit but does not specify the sample size (e.g., number of simulated procedures, number of particles visualized).
• Data Provenance: The testing was "simulated," implying in-house lab testing, not patient data from a specific country, nor retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• The document does not mention the use of experts to establish ground truth for any test set. The nature of the device (a catheter and a visualization kit) and the type of testing described (simulated use for an accessory) likely did not necessitate independent expert ground truth establishment in the way a diagnostic AI algorithm would.

4. Adjudication Method for the Test Set:

• Since there's no mention of experts establishing a ground truth for a test set, no adjudication method was needed or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically done for diagnostic imaging devices or AI algorithms where human interpretation is involved. This submission is for a medical device (catheter) and an accessory, not a diagnostic imaging AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

• Not applicable. The device is a physical catheter and a visualization kit, not an algorithm. Therefore, no standalone algorithm performance study was mentioned.

7. Type of Ground Truth Used:

• For the simulated use testing of the Particle Visualization Kit, the "ground truth" would likely be engineer-defined criteria and observations of whether the kit successfully facilitated the visualization of deliberately introduced embolic material. This is based on the functional description of the PVK. No mention of expert consensus, pathology, or outcomes data for this specific testing.

8. Sample Size for the Training Set:

• Not applicable. This device is hardware (catheter and accessory), not a machine learning or AI algorithm, so there is no "training set."

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

• Not applicable, as there is no training set.

In summary, the provided document focuses on establishing substantial equivalence for a non-AI physical medical device and an accessory. It describes the device's characteristics and notes that non-clinical simulated use testing was performed for the new accessory, but it does not delve into detailed quantitative acceptance criteria or elaborate on study designs typical of AI/diagnostic device submissions. The core argument is that the modified device is identical or substantially equivalent in its critical features to an already cleared predicate.

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