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The Attain™ LDS 6216A 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 wires to facilitate venous access, adjustable hemostasis valves to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

The Attain LDS 6216A Left-heart delivery system combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.

The key changes being made to the system are the addition of Tungsten Carbidefilled polyether block amide material to the guide catheter distal tip segment and the addition of extra slitters and adjustable hemostasis valves in a revised system configuration.

The provided text describes a 510(k) premarket notification for the Attain™ LDS 6216A Left-heart delivery system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or not present in this document. The focus of this 510(k) is on in vitro testing and demonstrating that the new device is functionally the same as an already approved device.

Here's a breakdown of the information that is available or can be inferred, along with explanations for the missing information:

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

Explanation: For a 510(k) submission, the "acceptance criteria" are generally that the new device performs as intended and is as safe and effective as the predicate device. Specific quantitative performance metrics with defined pass/fail thresholds, as would be seen in a clinical trial for a novel device, are typically not required or presented in this type of document. The "reported device performance" refers to the successful completion of the indicated tests.

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

• Sample Size for Test Set: Not specified. The document mentions "representative samples" for biocompatibility testing but does not quantify them. For in vitro mechanical testing, an exact sample size is generally not provided in the summary.
• Data Provenance: The document does not specify country of origin for the in vitro testing. It is conducted by the manufacturer, Medtronic, Inc., which is based in Minneapolis, MN, USA (submitter address). The testing is in vitro, not involving human subjects, so retrospective/prospective distinction is not applicable in the typical sense.

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

• This information is not applicable as this submission is based on in vitro physical and material performance testing, not on clinical data requiring expert interpretation (e.g., image analysis, diagnosis). The "ground truth" here is adherence to engineering specifications and approved testing standards.

4. Adjudication method for the test set

• This information is not applicable as the testing is in vitro and does not involve human readers or complex interpretations that would require adjudication.

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

• This information is not applicable. This is a medical device for delivery of catheters and leads, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the in vitro testing and biocompatibility is established by engineering specifications, recognized standards (e.g., ISO 10993-1 for biocompatibility), and manufacturing quality control parameters. It's based on objective measurements and established scientific principles for material and device performance, not on clinical outcomes, pathology, or expert consensus in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and performance are based on engineering principles and in vitro validation.

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

• Not applicable, as there is no "training set" for this device.

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