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The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is recommended for use in percutaneous dilatation of the iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque. This catheter is not intended for use in the coronary arteries. Any other use than those indicated is not recommended.

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a bilumen catheter with a controlled-compliance balloon mounted at the distal tip. The balloon is designed to inflate to a known diameter and length at a specific pressure and is inflated and deflated via the side port. The second lumen allows access to the distal tip of the catheter for guidewire insertion, pressure monitoring and infusion of contrast media. Two marker bands are positioned under the balloon at the proximal and distal tapers to aid in accurate placement.

The provided text describes a 510(k) premarket notification for the Smash™ PTA Catheter, which primarily relies on demonstrating substantial equivalence to a predicate device (Match-35™ PTA Catheter) rather than novel acceptance criteria and a standalone clinical study. Therefore, several of the requested sections about AI/algorithm performance, expert-established ground truth, and training sets are not applicable to this device submission.

Here's a breakdown based on the provided information:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the technical characteristics of the predicate device, the Match-35™ Percutaneous Transluminal Angioplasty (PTA) Catheter, and compliance with general performance testing guidelines. The "reported device performance" for the Smash™ PTA Catheter is that it performed acceptably in "non-clinical performance testing" similar to the predicate device and generally followed the "PTCA Balloon Catheters section in Part II of the 'Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices', May 1994."

Table of Acceptance Criteria (based on predicate device characteristics) and Reported Device Performance (Smash™ PTA Catheter):

Study Information:

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: Not specified. The submission refers to "non-clinical performance testing" which typically involves a defined number of units for each test (e.g., a certain number of balloons for burst pressure, fatigue).
   • Data Provenance: Not specified, but given it's non-clinical testing performed by Schneider (USA) Inc., it would be internal lab data, likely from the United States. It is prospective testing designed to evaluate the physical properties of the device.

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):

   • Not applicable. This is a medical device submission based on physical and mechanical performance testing, not diagnostic accuracy requiring expert interpretation of images or clinical data. The "ground truth" is established by measured physical properties and engineering specifications.

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

   • Not applicable. This pertains to clinical or diagnostic studies with human interpretation of data. The performance testing of this catheter would follow standard engineering and quality control protocols.

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:

   • Not applicable. This device is a medical catheter, not an AI-powered diagnostic or assistive technology.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

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

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

   • The "ground truth" for this submission is based on engineering specifications, measured physical and mechanical properties, and compliance with recognized industry standards and guidance documents (e.g., PTCA Balloon Catheters section in Part II of the "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices", May 1994).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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