(34 days)
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.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).