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The intended use of the ScoutPro 7F is for introducing leads into the vessels of the left heart via the coronary sinus.

The ScoutPro 7F delivery system is a modified version of the BIOTRONIK's current legally marketed ScoutPro delivery system (K03320, dated 11-19-2003). The ScoutPro 7F functions similarly to that of a standard introducer for pacemaker leads. It contains catheters with various distal arcs to facilitate and support the implantation of left-ventricular polyurethane leads up to 6.6 F in the coronary venous system.

For implantation of left ventricular pacing leads, the subclavian or the cephalic vein is used as a point of entry into the venous system. After gaining access to the vein, one of the braided, peel-away guiding catheters (long sheaths) used in combination with the dilator and hemostatic valve is introduced into the vein using a guide wire initially positioned in the atrium. Selection of a guiding catheter with a suitable curve (arc) allows the distal tip of the catheter to probe the coronary sinus and facilitates implantation of the lead into the coronary veins. A side access in the hemostatic valve enables the injection of irrigation solutions and contrast dyes to facilitate gaining access to the coronary sinus.

After successful placement of the hemostatic valve and the guiding catheter are removed over the lead. In this process, the pre-slitted peel-away grip, which is glued to the proximal end of the guiding catheter, is broken off. The catheter is opened along the pre-slit portion (2 cm). Then, using the slitter tool, the guiding catheter is slit from proximal to distal end.

The main difference between the predicate device ScoutPro and the ScoutPro 7F described in this documentation is the inner diameter of the guiding catheters included in the system. Most coronary sinus leads to be implanted have a smaller diameter, for which a 7F introducer system is sufficient.

The provided text is a 510(k) premarket notification for a medical device called ScoutPro 7F. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than exhaustive new clinical studies proving performance against absolute acceptance criteria.

Therefore, the document does not contain the kind of detailed information requested in the prompt regarding acceptance criteria, study performance, sample sizes, expert involvement, and ground truth establishment as would be found in a study designed to prove device performance from the ground up (e.g., for a PMA submission or a novel device).

Here's an breakdown based on the information provided, highlighting what is implicitly or explicitly stated and what is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for a 510(k) submission is typically showing substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as the predicate, often through comparisons of technological characteristics and intended use.
• Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, accuracy, sensitivity, specificity) are reported in a quantifiable manner for the ScoutPro 7F. The submission focuses on describing the device and its modifications relative to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided: The document does not describe a clinical "test set" in the sense of a study testing the device's performance in patients. This is a 510(k) submission, not a clinical trial report. Data provenance, if any, for non-clinical testing is not mentioned.

3. 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 / Not provided: As there's no described clinical "test set" with ground truth to be established, this information is not present.

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

• Not applicable / Not provided: No clinical test set means no adjudication method.

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

• Not applicable / Not provided: This device is a delivery system (catheter, guide wires, etc.) for coronary sinus leads, not an imaging or AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this product submission.

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

• Not applicable / Not provided: This refers to AI/algorithm performance. The ScoutPro 7F is a mechanical device, not an algorithm.

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

• Not applicable / Not provided: No clinical "ground truth" data is referenced in this submission. The basis for substantial equivalence is primarily comparison of technological characteristics and intended use to a previously cleared device.

8. The sample size for the training set

• Not applicable / Not provided: There is no "training set" in the context of device performance data for this submission. This term relates to machine learning models.

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

• Not applicable / Not provided: No training set or ground truth for it.

Summary based on the document:

This 510(k) submission for the ScoutPro 7F is based on demonstrating substantial equivalence to the predicate device, BIOTRONIK's ScoutPro (K033320). The modifications described are primarily the inner diameter of the guiding catheters and some accessory changes. The implicit "acceptance criteria" for this type of submission is satisfying the FDA that these modifications do not raise new questions of safety or effectiveness and that the device remains substantially equivalent to the predicate.

The document does not detail specific performance studies with quantitative data, sample sizes, or expert ground truth as would be required for novel device approval or other types of regulatory pathways.

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