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Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.

The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter. The catheter is triaxial in construction with two lumens being used to inflate the balloons while one lumen is being used for tracking over a guidewire. The purpose of the double balloon catheter is to apply an incremental inflation for the purpose of dilating a stent. The inner balloon provides initial expansion of the stent and also acts as a tool to hold the stent on the catheter prior to the outer balloon being inflated. The outer balloon is then inflated providing the remainder of the expansion. There are radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The balloon material is clear. The catheter balloon diameters are stamped onto the inflation extensions and are labeled with balloon diameter x balloon length and the catheter lot number.

The provided text describes a medical device, the NuMED BIB® Stent Placement Catheter, and its substantial equivalence to a predicate device. It includes performance data from in vitro testing and a clinical trial. However, the document does not explicitly state acceptance criteria in a quantitative format, nor does it present the study results specifically framed as meeting such criteria. Instead, it leverages prior testing and a clinical trial to demonstrate substantial equivalence.

Based on the provided text, here's an attempt to extract and infer the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, this table will present the key performance indicators from the leveraged studies, which implicitly served as the basis for performance evaluation for substantial equivalence.

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

• Test Set Description: The clinical study is referred to as the COAST trial.
• Sample Size: 112 patients were enrolled.
• Data Provenance: The COAST trial was a "prospective, multi-center, single arm study." While the specific country of origin is not explicitly stated, "multi-center" implies data from several locations, typically within a regulatory region (e.g., USA for FDA approval).

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

The provided text only refers to clinical trial data (COAST study) for safety and effectiveness. It does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic performance or image interpretation often associated with AI/ML devices. Therefore, this question is not applicable to the submitted document. The clinical outcomes served as the definitive measure of device performance.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set, as no "ground truth" establishment by multiple experts is discussed for diagnostic purposes. Clinical trial outcomes are typically assessed by study investigators and monitored, but not through an adjudication process in the sense of resolving discrepancies between expert opinions on a data point.

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

No such MRMC comparative effectiveness study is mentioned. The device is a physical medical device (stent placement catheter), not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable. The device is a physical medical device; it does not have a standalone algorithm or AI component.

7. The type of ground truth used

For the clinical study (COAST trial), the "ground truth" for evaluating the device's performance was:

• Clinical Outcomes/Events:
  • Rates of serious adverse events within 30 days.
  • Rates of post-procedure paradoxical hypertension.
  • Reduction in arm-leg systolic blood pressure gradient from baseline to 12 months.
  • Length of hospital stay.
• Successful implantation: The text states, "The results demonstrated that the CP Stent could be successfully mounted and implanted using the BiB Stent Placement Catheter..."

For the bench and biocompatibility testing, the "ground truth" was established based on pre-defined engineering specifications, material standards, and biological safety guidelines, which the device components were expected to meet.

8. The sample size for the training set

The document does not describe a "training set" in the context of AI/ML. The device is a physical medical device. The "leveraged" data from K050857 and P150028 could be considered as prior performance data used for development and comparison, but not a "training set" in the AI sense.

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

As there is no "training set" for an AI/ML algorithm described, this question is not applicable. The prior performance data from K050857 and P150028 were established through engineering tests, biocompatibility assessments, and clinical evaluation as per regulatory requirements for medical devices.

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