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The device is intended for the ablation of tissue in the removal of IVC filters that have failed a previous retrieval method.

The CavaClear Laser Sheath is a 14Fr or 16 Fr laser sheath that transmits ultraviolet energy in (b)(4) pulse durations from Spectranetics' Excimer Laser generators to the tissue at the distal tip of the device. When the laser activates, a small amount of the tissue is ablated through photochemical, photothermal, and photomechanical interaction, vaporizing tissue overgrowth in order to allow for inferior vena cava (IVC) filter removal. The CavaClear Laser Sheath operates at repetition rates of 25-80Hz and fluence of 30-60mJ/mm2.

The provided text describes the CavaClear Laser Sheath, a laser-powered device used for the retrieval of IVC filters that have failed previous removal methods. While the document details various aspects of the device's testing and clinical performance, it does not pertain to an AI/ML powered medical device. Therefore, information typically associated with AI/ML device acceptance criteria, such as training and test set data, ground truth establishment by experts, adjudication methods, and MRMC studies, is not present in this document.

The acceptance criteria and the study proving the device meets these criteria are based on traditional medical device evaluation metrics, focusing on safety and effectiveness in a real-world clinical setting.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the lack of AI-specific details:

Acceptance Criteria and Device Performance for CavaClear Laser Sheath

The acceptance criteria for the CavaClear Laser Sheath are defined by two primary performance goals: a safety endpoint and an efficacy endpoint. These goals were based on meta-analysis of existing literature for IVC filter retrieval procedures.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a retrospective analysis of real-world evidence from multiple medical centers.

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

   • Total Subjects: 265
   • Single-Center Experience (Test Set 1): 139 subjects
   • Multi-Center Experience (Test Set 2): 126 subjects from 6 sites
   • Data Provenance: United States (US), retrospective. Data was collected from medical records between March 2012 and February 2021.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The document states that "All site reported complications were independently adjudicated to assess relatedness to use of the laser and to evaluate the appropriate severity classification based on the current SIR guidelines."
   • Number of Experts: Not explicitly stated, but implies at least one independent adjudicator.
   • Qualifications of Experts: Not explicitly stated, but "adjudicated... based on the current SIR guidelines" implies experts familiar with interventional radiology and complication grading (e.g., interventional radiologists, vascular surgeons).

3. Adjudication Method for the Test Set:

   • "All site reported complications were independently adjudicated."
   • The specific method (e.g., 2+1, 3+1) is not detailed, but it was an independent review process based on SIR (Society of Interventional Radiology) grading guidelines for complications.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This study evaluated the performance of a physical medical device (laser sheath) in performing a medical procedure, not an AI/ML algorithm requiring human reader performance evaluation.

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

   • Not applicable, as this is not an AI/ML algorithm. The device's performance is inherently linked to human operation by trained medical professionals within a clinical setting.

6. The Type of Ground Truth Used:

   • The ground truth for safety (complications) and efficacy (technical success) was established through clinical judgment and independent adjudication of real-world patient outcomes, based on medical records and SIR grading guidelines. Technical success was defined based on practitioners' clinical judgment and reported as such.

7. The Sample Size for the Training Set:

   • Not applicable in the context of AI/ML training. The "training" for this device refers to human medical professional training on its use, not algorithmic training data.

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

   • Not applicable as there is no algorithmic training set. The "ground truth" for human training would be established through established medical protocols, clinical best practices, and expert consensus on effective and safe procedural techniques. The document mentions a required training program for users.

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