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The Attain LDS 6216 Left-heart delivery system is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The left-heart delivery system features two guide catheters for passing venogram balloon catheters or appropriate leads an adjustable hemostasis valve to reduce blood loss during the implant procedure, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters and a percutaneous introducer kit to facilitate venous access. The Attain LDS 6216 is intended for single use only and will be distributed independently for use with current and future leads. The Attain LDS 6216 combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.

The provided text describes a 510(k) premarket notification for the Attain LDS 6216 Left-heart delivery system. This document is a regulatory submission demonstrating substantial equivalence to previously marketed devices and does not contain acceptance criteria or study results in the format requested for a device with performance metrics like sensitivity, specificity, or accuracy.

The information provided focuses on the safety and functional performance of a medical device (catheter delivery system) through a comparison to predicate devices and general testing, rather than a diagnostic algorithm or AI system. Therefore, many of the specific questions regarding acceptance criteria, performance metrics, ground truth, and expert involvement are not applicable to the content of this document.

However, based on the provided text, I can extract the following relevant information regarding the device's validation:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a delivery system, explicit "acceptance criteria" presented as quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not detailed in the same way they would be for a diagnostic device or AI algorithm. Instead, the "acceptance criteria" are implied by the successful completion of various engineering and clinical performance tests, ensuring the device functions as intended and is safe. The "reported device performance" refers to the successful outcomes of these tests and its performance in clinical trials where it was used.

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

• Test Set (Clinical Data): The device was included in two clinical investigations:
  • Medtronic Model 8040 InSync System (MIRACLE) clinical investigation (G980219)
  • Model 7272 InSync ICD System (MIRACLE ICD) clinical investigation (G990176)
• Sample Size: The document does not specify the exact number of patients or cases where the Attain LDS 6216 was used within these larger clinical trials. It only states its inclusion.
• Data Provenance: The studies were prospective clinical investigations (implied by "clinical investigation" and "approved" by the FDA with corresponding G-numbers). The country of origin for these specific clinical investigations is not explicitly stated in the provided text, but Medtronic is a US-based company, suggesting these were likely US-based or international trials following FDA guidance.

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

This information is not provided. For a delivery system, "ground truth" as typically defined for diagnostic AI (e.g., presence/absence of disease confirmed by an expert) is not directly applicable. The "ground truth" in this context would be the successful use and performance of the delivery system in facilitating a procedure, which would be assessed by the physicians performing the procedure in the clinical trials.

4. Adjudication method for the test set

This information is not provided nor directly applicable in the same way it would be for a diagnostic tool where multiple readers might disagree on findings. Success and failure in a surgical delivery system are often objective (e.g., successful lead placement, absence of complications).

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 MRMC study was conducted or is applicable here. The device is a physical delivery system, not an AI or diagnostic tool that assists human readers.

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

This question is not applicable. The Attain LDS 6216 is a physical medical device, not an algorithm. Its performance is always "human-in-the-loop" as it requires a physician to operate it.

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

For the clinical performance aspects, the "ground truth" would be the clinical outcomes data from the MIRACLE and MIRACLE ICD investigations, specifically focusing on the successful placement of leads and balloon catheters, and the absence of device-related adverse events during these procedures. For the in-vitro testing, the "ground truth" was established by engineering specifications and test standards.

8. The sample size for the training set

This question is not applicable. The device is a physical product, not a machine learning model that requires a training set. Its design and development would involve engineering prototypes and bench testing.

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

This question is not applicable. As explained in point 8, there is no "training set" in the context of an algorithm. The "ground truth" for the device's design and in-vitro testing would be established through industry standards, performance specifications, and engineering validation processes.

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