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The MitraClip G5 Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.
The TriClip G5 Steerable Guide Catheter is used for introducing various catheters into the right side of the heart.

The MitraClip G5 Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The device provides a conduit to access the left atrium. The SGC's primary function is to dilate the atrial septum, maneuver to the target location above the mitral valve, and position the CDS. The MitraClip G5 Steerable Guide Catheter is provided sterile and for single use only.
The TriClip G5 Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the right side of the heart. The TriClip G5 Steerable Guide Catheter is provided sterile and for single use only.
The MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter are equivalent in terms of design, material, principle of operation, and sterilization method. There are minor differences in design to facilitate access to different areas of the heart.

This FDA 510(k) summary for the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through the kind of study typically associated with AI/software as a medical device (SaMD) clearances.

Therefore, many of the requested elements (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable or not provided in this document as it pertains to a physical medical device (catheter) and its inherent performance characteristics (e.g., tensile strength, steering performance), not an AI algorithm.

However, I can still extract the information regarding the device's acceptance criteria and the engineering and bench testing performed to demonstrate that the device meets its design specifications, as this is the "study" proving the device meets the acceptance criteria for a physical device.

Device: MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter

Type of Device: Percutaneous Catheter (Class II)

Purpose of the Submission: Demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to engineering, material, and functional specifications, and "reported device performance" refers to the results of bench and biocompatibility testing. The document states that testing was "conducted to demonstrate that the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter met all performance specifications." While specific numerical performance values are not detailed in this summary, the categories of tests act as implicit acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes are typically determined by statistical methods for each specific test (e.g., a certain number of catheters for tensile strength, a certain number of packaging samples).
• Data Provenance: This is an internal company study (Abbott Medical). The data would be from controlled laboratory and manufacturing environments. This is retrospective in the sense that the testing is performed on manufactured devices to confirm their design and production quality before submission. There is no patient-specific data or country-of-origin context in this type of submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable in the context of this device. Ground truth for a physical catheter (e.g., whether it has adequate tensile strength) is established by engineering specifications, validated test methods, and measurement equipment, not by expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication typically applies to expert assessments of medical images or clinical outcomes. For device performance testing, results are typically objective measurements, passing/failing criteria, or standardized biological responses.

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. This is a physical medical device (catheter), not an AI/software. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• For biocompatibility: Established by international standards (ISO 10993 series) and validated analytical/biological testing methods.
• For design verification: Established by engineering design specifications and validated bench test methods.
• For sterilization: Established by international standards (ISO 11135).
• For packaging: Established by international standards (ISO 11607 series).

8. The Sample Size for the Training Set

• Not Applicable. "Training set" refers to data used to train AI models. This is a physical device and does not involve an AI component.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As above, there is no "training set" for this physical device.

Summary for this specific document:

This FDA submission is for a conventional medical device (a steerable guide catheter) and focuses on demonstrating substantial equivalence to existing predicate devices. The "acceptance criteria" and "proof" primarily involve a battery of bench tests and biocompatibility assessments to ensure the device meets engineering specifications, is safe for its intended biological contact, and can be reliably sterilized and packaged. The methodologies described are standard for physical medical devices and do not involve the types of clinical performance studies, reader studies, or AI algorithm validation typically discussed for AI/SaMD submissions.

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