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The ScoutPro ACS guiding catheters are used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

The ScoutPro ACS accessory kit is used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

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The provided document is a 510(k) premarket notification letter from the FDA for the Biotronik, Inc. ScoutPro ACS CS Lead Introducer System. It confirms that the device is substantially equivalent to a predicate device for its stated indications for use.

Crucially, this document does not contain information about acceptance criteria or specific study data proving the device meets acceptance criteria. It is a regulatory clearance letter, not a scientific study report.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as an FDA clearance stating that the device is "substantially equivalent" to predicate devices, meaning it has similar technological characteristics and is intended for the same use as legally marketed devices. The detailed performance data and acceptance criteria would have been part of the 510(k) submission that led to this clearance letter, but are not included in the letter itself.

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