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The Acumen Lead Delivery Sheath with Stylet is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Lead Delivery Sheath with Stylet is a single-use percutaneous catheter intended to The Acumen Lead Delivery Birean West villator leads and catheters. The Acumen Lead Delivery Sheath with Stylet has a guidewire lumen and a lumen for introduction of leads. The Acumen Silean with Stylet was a gurdential be packaged with a stylet to aid in positioning of the device in the vasculature.

This document, K070197, describes a 510(k) premarket notification for the "Acumen Lead Delivery Sheath with Stylet." The information provided is a summary of the device's intended use, description, and a statement of substantial equivalence to a predicate device. It does not contain the kind of detailed study data, acceptance criteria, and performance results that would be expected for a typical medical device performance study, especially for AI/ML devices.

Based on the provided text, here's what can be extracted and what information is not available:

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

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

• Sample Size for Test Set: Not specified. The document broadly states "Appropriate testing has been performed" without detailing the nature or scope of this testing, including sample sizes for any test sets.
• Data Provenance: Not specified.

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)

• Number of Experts: Not applicable. This device is a medical instrument (lead delivery sheath), not an AI/ML diagnostic or prognostic tool that would typically involve expert-established ground truth from image or other medical data. The testing mentioned would likely involve engineering and biocompatibility tests, not expert reviews of diagnostic interpretations.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. As this is not an AI/ML diagnostic or prognostic device, adjudication methods related to expert consensus on diagnostic interpretations are not relevant.

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

• MRMC Study: No. This is a medical instrument, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies are not relevant.
• Effect Size: Not applicable.

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

• Standalone Study: No. This device is a component used in a medical procedure, not an AI algorithm.

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

• Type of Ground Truth: Not applicable in the context of an AI/ML device. For a physical medical device like this, "ground truth" would refer to established engineering specifications, material properties, and biological compatibility standards. The document only mentions "required specifications for the completed tests."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set" in the machine learning sense.

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

• Ground Truth for Training Set Establishment: Not applicable.

Summary of what is present:

The submission highlights the device's intended use (introduction of pacing/defibrillator leads and catheters) and states its substantial equivalence to a predicate device (Acumen Lead Delivery Sheath, K062145). The substantial equivalence is based on "identical or substantially equivalent" factors in intended use, method of operation, construction, and materials. The document confirms that "appropriate testing has been performed" and that the device "met the required specifications," but it does not provide any details about these tests, the specific specifications, or the results.

This type of 510(k) submission for a non-AI physical medical device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a combination of engineering testing, materials analysis, and comparison of design features. Detailed performance metrics and study designs, as requested in your prompt (which are common for AI/ML devices), are generally not included in this high-level summary for traditional medical devices.

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