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The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus.

ScoutPro 8F is a special delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left heart via the coronary sinus. It facilitates access to the coronary sinus venous system as well as probing the coronary sinus. It is a modified version of BIOTRONIK's currently legally marketed predicate device, ScoutPro (K033320, 11-19-2003). The following ScoutPro 8F accessories are subject to this 510(k): The basic set ScoutPro 8F contains the following components: 1 hemostatic valve, 2 guiding catheters Blo I and Blo 2, 1 dilator for the guiding catheter, 1 peel-away sheath 11F with dilator, 1 guide wire, 1 needle, 1 syringe, 2 slitter tools 4.9 F and 6.3 F for different lead sizes. ScoutPro 8F Sheath "Hook" contains the following components: 1 quiding catheter "Hook", 1 dilator for the guiding catheter. ScoutPro 8F Sheath "Multi-Purpose Hook" contains the following components: 1 guiding catheter "Multi-Purpose Hook", 1 dilator for the guiding catheter. ScoutPro 8F Sheath "Amplatz 6.0" contains the following components: 1 guiding catheter "Amplatz 6.0", 1 dilator for the guiding catheter. Additionally, the hemostatic valve and the slitter tools are available separately. These accessories have been cleared with the legally marketed predicate device ScoutPro (K033320, 11-19-2003).

This document is a 510(k) Premarket Notification for the ScoutPro 8F, a medical device for introducing leads into the heart. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the context of an AI/algorithm-driven device.

Therefore, the information requested for AI device studies, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, cannot be found in this document.

This document is a regulatory submission for a physical medical device (a catheter delivery system), not an AI/software as a medical device (SaMD). The regulatory pathway and the type of evidence required are different.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) because this is a 510(k) for a physical device, not an AI/diagnostic algorithm. The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

• Reported Device Performance: The document describes the device and its modifications but does not report specific performance data (e.g., success rates, complication rates from clinical trials directly in this summary). The basis for demonstrating substantial equivalence often relies on:

  • Bench testing: To ensure modifications maintain material integrity, functional dimensions, and performance characteristics.
  • Biocompatibility testing: To ensure materials are safe for human contact.
  • Sterilization validation: To ensure the device can be consistently sterilized.
  • Software validation (if applicable, though minimal for this device): To ensure any embedded software functions correctly.
  • Comparison to predicate device's known performance: The assumption is that if the new device is substantially equivalent, it will perform similarly to the predicate.

  The document states: "The main difference between the predicate device ScoutPro and the ScoutPro 8F described in this documentation are some modifications with the accessories included in the system. The changes to the accessories include the markings on the hemostatic valve, a bigger scaled syringe and a different plastic material and a different steel blade for slitter tools." The implicit performance claim is that these modifications do not negatively impact the core function (introducing leads into vessels of the left heart) or safety compared to the predicate.

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

• Not applicable for this type of submission. This document does not describe a clinical study with a test set of patient data as one would for an AI algorithm. Substantial equivalence for this kind of physical device is typically demonstrated through engineering testing, material testing, and comparison of design features.

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

• Not applicable. There is no "ground truth" establishment in the context of an AI product review. The "truth" in this submission relies on engineering principles, established medical device standards, and the predicate device's safety and effectiveness history.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method is described, as there isn't a test set of cases needing expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant here.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

• Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

• Not applicable in the AI sense. For a physical device like this, the "ground truth" for proving substantial equivalence lies in:
  • Functional Testing: Does the device perform its intended mechanical functions?
  • Material Compatibility: Are the materials safe and effective?
  • Biocompatibility: Is it safe for the human body?
  • Sterility Validation: Is it demonstrably sterile?
  • Predicate Device Performance: The predicate device (BIOTRONIK's ScoutPro #K033320) serves as the benchmark against which the new device is compared in terms of safety and effectiveness.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI training set involved in this 510(k) submission.

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

• Not applicable. There is no AI training set involved.

Summary of what's provided related to the request (if the device were an AI/SaMD):

• Predicate Device: BIOTRONIK's ScoutPro (#K033320, 11-19-2003) is identified. For an AI/SaMD, this would be a predicate AI/SaMD or a conventional diagnostic method that the new AI algorithm aims to be substantially equivalent to.
• Intended Use: "The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus." This is crucial for any device, including AI, as it defines the scope of its application.

This document clearly outlines the regulatory path for a physical medical device. The framework for evaluating an AI/SaMD is distinctly different, requiring evidence related to algorithm performance on diverse datasets, expert evaluation of ground truth, and often clinical utility studies.

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