(267 days)
The Medtronic® Model 3998 Specify™ Lead is indicated in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach to chronic pain alleviation.
The Medtronic Specify Model 3998 Lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end. At the proximal end of each lead body are the lead contacts, which fit into a Medtronic in-line, four-conductor connector. The Model 3998 lead can be used with any Medtronic products that have two in-line connectors, including: The Mattrix system, Model 3272 receiver; The Bifurcated Y-extension, Model 7498, which can be used with the Itrel or Xtrel system.
In the provided text, Medtronic, Inc. describes the Medtronic® Specify™ Model 3998 Lead for Implanted Spinal Cord Stimulation and its comparison to predicate devices, focusing on demonstrating substantial equivalence rather than meeting specific performance acceptance criteria for a new type of device.
Therefore, the response below is adapted to reflect that the study primarily aims to show substantial equivalence through various performance tests against existing predicate devices, rather than meeting predefined numerical acceptance criteria against clinical performance metrics.
Description of Acceptance Criteria and Proving Device Meets Criteria:
The Medtronic® Specify™ Model 3998 Lead is intended to be substantially equivalent to existing Medtronic Spinal Cord Stimulation leads. Therefore, the "acceptance criteria" are based on demonstrating comparable performance and characteristics to these predicate devices rather than independent, predefined numerical thresholds for clinical outcomes.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Demonstrating Substantial Equivalence) | Reported Device Performance (Medtronic® Specify™ Model 3998 Lead) |
|---|---|
| Product Labeling | Substantially equivalent to existing Medtronic SCS leads. |
| Intended Use | Same intended use as many current Medtronic SCS leads: management of chronic pain of the trunk and limbs. |
| Physical Characteristics (Materials) | Materials used are identical to predicate device leads. |
| Physical Characteristics (Structure) | Consists of two lead bodies attached to a paddle with eight stimulating electrodes, functionally equivalent to two current Medtronic leads combined. |
| Anatomical Sites | Placed within an epidural space of the spinal cord, same as existing Medtronic SCS leads. |
| Performance - Paddle Flex Testing | Indicated flex characteristics equal to other currently available Medtronic leads. |
| Performance - Tensile Strength Testing | Indicated adequate strength to perform its intended use. |
| Performance - DC Resistance Testing | Indicated adequate connections exist. |
| Performance - Cross Circuit Impedance Testing | Concluded isolation to be adequate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described (paddle flex, tensile strength, DC resistance, cross-circuit impedance) appears to be laboratory-based engineering testing performed on the Model 3998 lead itself and possibly comparing its properties to predicate devices.
- Sample Size: Not explicitly stated for each test (e.g., number of leads tested).
- Data Provenance: The tests are described as having been performed by Medtronic, Inc. This suggests internal laboratory testing rather than data from external clinical sites or specific countries. The data is not described as retrospective or prospective clinical data but rather engineering test results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This type of information is typically related to clinical studies or performance evaluations where expert review or consensus establishes a "ground truth" (e.g., for diagnostic accuracy). The provided text describes engineering performance testing against physical and electrical properties, not clinical ground truth established by medical experts for a test set.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to a process where multiple experts review and reach a consensus on a diagnosis or outcome, usually in clinical trials. The tests described are engineering evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document does not describe any clinical studies involving human readers or their improved performance with or without AI assistance. The focus is on the substantial equivalence of the device's physical and electrical properties to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical lead, not an algorithm or AI system, so "standalone" performance in that context is not relevant. The performance testing refers to the physical and electrical functioning of the lead itself.
7. The Type of Ground Truth Used:
The ground truth for the engineering performance tests is based on established engineering specifications, material properties, and functional requirements for implantable medical devices of this type, as well as comparison to the measured properties of predicate devices. For example, "adequate strength" for tensile testing would be determined by predefined engineering standards for the device's intended use.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The product is a physical medical lead.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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).