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The Medtronic Pisces Z Quad® Model 3890, Pisces Z Quad Compact™ Model 3891, and Pisces Z Quad Plus® Model 3892 Leads for Spinal Cord Stimulation (SCS) are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs.

The function of the Medtronic Mattrix and X-trel® Neurostimulation Systems is accomplished with a power source, extension (for X-trel only) and lead (electrode). The power source generates and controls the stimulation, which is delivered to the spinal cord via electrodes at the end of the lead.

The Models 3890, 3891 and 3892 Leads are lower impedance percutaneous quadripolar, implantable leads. The proximal end provides in-line fourconductor contacts that connect to the Mattrix receiver or Medtronic extension (which connects to the X-trel receiver). The proximal ends and lead bodies of all three leads are identical. Each lead model has four platinum iridium electrodes on the distal end but with variable electrode length and spacing. The electrode spacing and electrode lengths of the Models 3890, 3891, and 3892 Leads are identical to the current Models 3487A, 3887, 3888 Leads, respectively. A radio-opaque marker band at the tip of the Model 3892 Lead enhances identification when viewed in fluoroscopy. The Models 3890, 3891 and 3892 Leads are available in lengths from 10 cm to 100 cm. The Medtronic Models 3890, 3891, and 3892 Leads are packaged, sterilized, and labeled for single use only (disposable).

This document is a 510(k) premarket notification for Medtronic Models 3890, 3891, and 3892 Leads, which are spinal cord stimulator leads. The information provided heavily focuses on regulatory aspects and substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not present in the provided text. The document primarily establishes that the new devices are substantially equivalent to previously cleared devices (Models 3487A, 3887, and 3888 Leads). This substantial equivalence is based on similar design, materials, and intended use.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not present in the provided document. The submission is a 510(k) for substantial equivalence, not a clinical trial report with performance metrics against predefined acceptance criteria. The document states that the electrode spacing and electrode lengths of the new models are "identical to the current Models 3487A, 3887, 3888 Leads, respectively," implying that their performance is expected to be similar to these predicate devices.

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

This information is not present. No "test set" in the context of a clinical performance study is described. The 510(k) submission relies on comparison to predicate devices, not on new clinical data demonstrating performance against specific criteria.

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)

This information is not present. Ground truth for a test set is not discussed as no such performance study is described.

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

This information is not present. Adjudication methods are relevant for studies involving human interpretation or subjective endpoints, which are not described here.

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 present. This device is a medical lead for spinal cord stimulation, not an AI-powered diagnostic tool, so an MRMC study and AI assistance are not applicable.

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

This information is not present. As this is not an algorithm or AI-based device, standalone performance as described is not relevant.

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

This information is not present. No specific ground truth determination is mentioned as a formal performance assessment is not part of this 510(k) submission. Substantial equivalence is based on comparison to existing, legally marketed devices.

8. The sample size for the training set

This information is not present. No training set is described as this is not an AI/machine learning device.

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

This information is not present. No training set or associated ground truth establishment is described.

Summary of available information related to equivalence/performance:

The document focuses on establishing substantial equivalence to predicate devices. The key argument for this equivalence is based on the following:

• Identical Electrode Design: "The electrode spacing and electrode lengths of the Models 3890, 3891, and 3892 Leads are identical to the current Models 3487A, 3887, 3888 Leads, respectively."
• Similar Components: "The proximal ends and lead bodies of all three leads are identical."
• Intended Use: The indications for use for the new leads are presented as an 'aid in the management of chronic, intractable pain of the trunk and/or limbs,' which is typically consistent with the indications for predicate spinal cord stimulator leads.

Essentially, the "study" that "proves" the device meets any implied "acceptance criteria" (which would be related to safety and effectiveness) is the demonstration of substantial equivalence to predicate devices already on the market and deemed safe and effective. This is the standard pathway for 510(k) clearances. No de novo clinical performance study is described in this document.

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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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