(28 days)
The Model 3875 1 x 8 SC Test Stimulation Lead is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:
- Failed Back Syndrome or Low Back Syndrome or Failed Back; .
- Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed . Back Syndrome;
- . Post Laminectomy Pain;
- ◆ Unsuccessful Disk Surgery;
- . Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and surgical interventions;
- . Peripheral Causalgia;
- . Epidural Fibrosis;
- Arachnoiditis or Lumbar Adhesive Arachnoiditis; ◆
- Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) . or Causalgia; and,
- Multiple Back Surgeries .
Additional Contraindication: The Medtronic Model 3875 1 x 8 SC Test Stimulation Lead is contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.
The Model 3875 1 x 8 SC is a test stimulation lead with accessories included in the kit. A test stimulation lead is a thin wire covered by an insulative coating, which is intended to be connected to a screening cable and to an external neurostimulator (ENS). The lead has small metal electrodes near its tip through which the ENS delivers electrical stimulation to an area where pain signals will be blocked.
The provided text, K062041, is a 510(k) summary for a medical device (Medtronic Model 3875 1 x 8 SC Test Stimulation Lead). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance metrics in the way a diagnostic AI device submission might.
Therefore, many of the requested sections about study design, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or cannot be extracted from this type of regulatory submission. The document relies on in vitro testing and material equivalence, not clinical performance studies with human subjects.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of acceptance criteria and reported device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) because it's for a physical medical device (a neurostimulation lead) and not a diagnostic algorithm. The acceptance criteria for this submission are based on demonstrating equivalence to predicate devices through in vitro testing and material composition.
The "performance" is implicitly deemed acceptable if it meets the prior in vitro testing standards of the predicate devices.
| Acceptance Criteria Type | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical/Electrical | Equivalent to predicate devices (Model 3873 & 3874) as demonstrated by previously performed in vitro testing. | Previously performed in vitro testing on the design of Model 3875 1 x 8 SC was deemed sufficient; repeat testing unnecessary. |
| Sterilization | Utilize the same 100% Ethylene Oxide (EtO) sterilization process as predicate devices and remain STERILE. | The device uses the same 100% EtO sterilization process as predicate devices. Labeled STERILE. |
| Biocompatibility | Materials are identical to predicate devices and assessed consistent with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." | All materials are identical to predicate devices (Models 3873 and 3874) and were found to be biocompatible and in compliance with ISO 10993-1. |
| Intended Use | Same as predicate devices. | Intended use and indications are the same as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of submission. The "test set" here refers to in vitro testing of the device itself (mechanical, electrical properties, etc.), not a clinical dataset of patients. The document does not specify sample sizes for these in vitro tests but refers to prior reports (07TR.020 and NDHF1174-90920). Data provenance is from internal in vitro testing by Medtronic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device does not have a "ground truth" established by clinical experts in the context of diagnostic accuracy. Its performance is assessed against engineering and material specifications.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" in the clinical sense for this device's submission. Performance is based on meeting engineering and material standards.
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 not an AI or diagnostic imaging device that involves human readers or comparative effectiveness studies of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical neurostimulation lead, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's submission is based on:
- Engineering specifications and standards: Ensuring the device meets design requirements for its intended physical function.
- Material composition data: Verification that materials are identical to previously approved biocompatible materials used in predicate devices.
- Sterilization validation: Confirmation that the sterilization process achieves the required sterility assurance level.
These are not clinical "ground truths" like pathology or expert consensus on patient outcomes/diagnoses.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).