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The ScoutPro Slitter Tool Advanced is used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

The ScoutPro family of introducer systems and accessories is specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The ScoutPro Slitter Tool Advanced represents further development of the ScoutPro Slitter Tool, which is part of the ScoutPro family of coronary sinus lead delivery systems. The main difference between the modified Slitter Tool Advanced and its predecessor is a more ergonomic design of the grip in order to optimize the handling and to enable a smooth removal of the delivery system. The optimized design is achieved by fabricating the entire device out of stainless steel. The Slitter Tool Advanced can be used with all BIOTRONIK coronary sinus leads with diameters 4.1F to 7.2F. Thus the optimized Slitter Tool Advanced covers the same lead diameter range as the two preceding Slitter Tools combined. The usage of the Slitter Tool remains unchanged and the product characteristics such as indications, contraindications, and function of the Slitter Tool Advanced are identical to the previous Slitter Tool. The ScoutPro Slitter Tool Advanced is a separately sold accessory that can be used in conjunction with the ScoutPro family of coronary sinus lead introducer systems.

This looks like a Special 510(k) for a modified medical device, the ScoutPro Slitter Tool Advanced. Special 510(k)s are primarily used for minor modifications to a manufacturer's own legally marketed device, where the modifications do not significantly alter the device's fundamental scientific technology or safety and effectiveness.

For such submissions, the focus of the testing and acceptance criteria is often on demonstrating that the changes to the device do not adversely affect its performance compared to the predicate, rather than establishing entirely new performance criteria. Therefore, the details you're asking for, such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies, are typically not part of a Special 510(k) and are not present in the provided text.

The document states: "The usage of the Slitter Tool remains unchanged and the product characteristics such as indications, contraindications, and function of the Slitter Tool Advanced are identical to the previous Slitter Tool." This indicates that the core functionality is assumed to be equivalent to the predicate, and the focus of the submission is on the design change (more ergonomic grip, stainless steel fabrication, covering a wider lead diameter range).

Here's an analysis based on the information provided, highlighting why many of your questions cannot be answered from this specific document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in quantitative terms or report specific performance metrics for the ScoutPro Slitter Tool Advanced beyond the physical characteristics changed. Instead, the submission relies on demonstrating substantial equivalence to its predicate device, the BIOTRONIK's ScoutPro 7F (#K060807, 04-24-2006).

The key "performance" aspect mentioned is the ability to work with a range of lead diameters:

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

• Not explicitly stated in the provided text. For a Special 510(k) focused on design changes and substantial equivalence, the testing often involves bench testing (e.g., mechanical strength, material compatibility, dimensional analysis) to ensure the changes don't introduce new risks or degrade performance. The specific test quantities and data provenance for such tests are not detailed here.

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

• Not applicable/Not stated. This type of information is typically reserved for studies involving subjective human assessment (like image interpretation or clinical outcomes) or establishing a complex diagnostic ground truth. For a mechanical device modification, expert "ground truth" for performance would likely be based on engineering specifications and bench test results, often reviewed by in-house experts.

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

• Not applicable/Not stated. Adjudication methods are usually relevant to studies with multiple readers or assessments that require conflict resolution regarding a 'ground truth'. For physical device testing, adjudication is less common.

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, an MRMC study was not done. This is a medical device (a slitter tool), not an AI/software device that assists human readers with interpretation. Therefore, MRMC studies are not relevant to this submission.

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

• No, a standalone algorithm performance study was not done. This is a mechanical medical device, not an algorithm.

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

• For this type of device modification, the "ground truth" would be established through engineering specifications, material science standards, and the performance characteristics of the predicate device. Testing would likely confirm that the new design meets these established engineering and safety benchmarks, and that the material change (stainless steel) is appropriate.

8. The sample size for the training set:

• Not applicable/Not stated. There is no "training set" in the context of this mechanical device modification. Training sets are relevant for machine learning or AI models.

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

• Not applicable/Not stated. As there is no training set, this question is not relevant.

Summary based on the Provided Text:

The Special 510(k) for the ScoutPro Slitter Tool Advanced is based on demonstrating substantial equivalence to its predicate by showing that:

• The device's function, indications for use, and contraindications are identical to the previous version.
• The design modifications (more ergonomic grip, stainless steel fabrication) improve handling and allow for compatibility with the combined lead diameter range of the previous two tools, without introducing new safety or effectiveness concerns.
• The primary "study" supporting this would be a comparison of the modified device to the predicate device through bench testing and potentially design verification/validation activities (e.g., material testing, dimensional checks, simulated use testing) to ensure the new design performs as intended and does not compromise safety or efficacy. The specific details of these tests (e.g., number of units tested, specific parameters measured) are not included in this high-level summary but would be part of the full 510(k) submission.

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