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The Medtronic Grip-lock™ Anchor is indicated for use to facilitate Medtronic neurological lead fixation.

The Grip-lock™ Anchor is an implantable, sterile, nonpyrogenic anchor which has been compatible with existing Metronic Neurological leads. The design is based on existing anchors (Twist-Lock Anchor) currently marketed for use with Medtronic Neurological Leads.

The anchor is not pre-attached to the lead but is provided separate from the lead in a default-closed configuration. By squeezing the polysulfone wings together, the physician can slide the anchor onto the lead. Grooves in the polysulfone wings provide a location for the physician to grip the wings with rubber-shod forceps. The physician can readjust the position of the anchor by squeezing the polysulfone wings and sliding the anchor along the lead body to the desired position.

Once the anchor is in the desired position the physician can suture the anchor to tissue using the suture holes of each polysulfone wing and the suture T attached to the anchor body.

The gripping mechanism of the Grip-lock™ Anchor is similar to that used by the Twist-Lock Anchor currently cleared for use with spinal cord stimulation (K972906).

The Medtronic Grip-lock™ Anchor has "new technological characteristics (e.g., design, materials and manufacturing processes)" from the current Medtronic Twist-Lock Anchor. The new technological characteristics are listed below:

• Materials : Nitinol Band of the Grip-lock™ Anchor .
  The Grip-lock Anchor is made primarily of polysulfone. A nitinol band encircles the anchor and serves as the closing mechanism of the anchor. Nitinol is commonly used is the medical device industry including use in cardiac stents.

• Closing mechanism of the Grip-lock " Anchor: Default closed, polysulfone wings squeezed . to open.
  The Grip-lock" Anchor is provided in a "default-closed" configuration and is not preattached to the lead. When placing the anchor on the lead the physician can squeeze the polysulfone wings which open the anchor and allow the anchor to be moved along the length of the lead body. The Twist-Lock Anchor is also not pre-attached to the lead. When placing the anchor the physician twists the anchor to close it on the lead body.

The information provided describes the acceptance criteria and a study conducted for the Medtronic Grip-lock™ Anchor device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the "performance data demonstrate" that the device is substantially equivalent to the predicate device, implying that the acceptance criteria for each test were met by virtue of achieving comparable performance to the established predicate. However, the specific quantitative acceptance criteria or numerical results are not provided in this summary.

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

The document does not explicitly state the sample size used for the test set for any of the performance tests (Adjustability and Placement, Pull Force, Suture Hole Strength, Flex Life).

The data provenance is not explicitly stated in terms of country of origin, nor is it specified as retrospective or prospective. It is implied these were prospective bench tests performed by the manufacturer, Medtronic, Inc.

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

Not applicable. The "ground truth" in this context refers to engineering performance metrics rather than clinical diagnoses established by experts.

4. Adjudication Method for the Test Set

Not applicable. The tests are engineering performance tests with measurable outcomes, not requiring adjudication in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study focuses on the physical performance characteristics of a medical device (an anchor) rather than diagnostic accuracy or human reader performance.

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

Yes, the studies described are standalone performance tests of the device itself, without human-in-the-loop performance measurement beyond the execution of the tests (e.g., a technician performing a pull force test). The "algorithm" in this context refers to the device's mechanical function, not a computational algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests was based on engineering specifications and comparative performance to a legally marketed predicate device (Medtronic Twist-Lock Anchor). This involves direct measurement of physical properties and behaviors of the device under controlled laboratory conditions, rather than expert consensus, pathology, or outcomes data. For material analysis, ISO 10993-1 provides the standard for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical anchor, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

Not applicable, as there is no training set for this type of device.

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