(30 days)
ANS Renew Lead Extensions are indicated for the treatment 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. Lead extensions are intended to be used with Advanced Neuromodulation Systems, leads, receivers, transmitters, and antennae.
The Renew Lead Extension consists of a silicone connector body, with Platinum/Iridium contacts, and braided wire cable inside a polyurethane sheath. Lead extensions are designed to be implanted to add additional length to the lead for connection to a receiver or externalized for use during a trial stimulation period not to exceed 30 days.
The provided document is a 510(k) summary for the Renew Lead Extension, a medical device. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions several tests and states that "The results demonstrated that the acceptance criteria were met for the following tests." However, it does not explicitly list the specific acceptance criteria values or the reported performance values for each test. It only provides the names of the tests performed.
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Insulation Resistance | Not specified | Met acceptance criteria |
| Conductor Resistance System Impedance | Not specified | Met acceptance criteria |
| Dielectric Strength | Not specified | Met acceptance criteria |
| Accelerated Contact Resistance | Not specified | Met acceptance criteria |
| Connector Pull Test | Not specified | Met acceptance criteria |
| Lead Body Flex Life | Not specified | Met acceptance criteria |
| Strain Relief Flex Life | Not specified | Met acceptance criteria |
| Stiffness | Not specified | Met acceptance criteria |
| Setscrew Block Retention | Not specified | Met acceptance criteria |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for the described non-clinical tests. It also does not provide information about data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical (engineering) bench tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This is not applicable. The "test set" in this context refers to physical devices undergoing engineering tests, not a dataset requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods are typically used in studies where multiple human readers interpret data, not for objective engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This document describes non-clinical engineering testing for a medical device's components and materials, not a study evaluating human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a "standalone" study in the context of an algorithm's performance was not done. This device is a physical lead extension, not an algorithm.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be established by the engineering specifications and test standards for each specific parameter (e.g., a specific resistance value, a minimum pull force). The document doesn't explicitly state these specific ground truths but implies adherence to established engineering standards for medical devices.
8. The Sample Size for the Training Set:
This is not applicable. This document describes the testing of a physical medical device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no training set for this type of device testing.
§ 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).