(23 days)
ANS Renew Receivers 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. Receivers are intended to be used with Advanced Neuromodulation System', leads, extensions, transmitters and antennae.
Renew Receiver contains electronic circuitry that decodes and converts programming data into stimulation pulses. The circuitry is hermetically and encapsulated in enoxy. The lead connection adapter, header, on the receiver is covered and sealed with biocompatible silicone rubber.
The provided text is a 510(k) summary for the Renew Receiver, a medical device. It describes the device, its intended use, and comparison to predicate devices, but it does not provide details about a study to prove acceptance criteria or device performance in the way a clinical trial or performance study would for an AI/ML-driven device.
The "Non-clinical Testing" section states: "Biocompatibility testing of the material is provided in the manufacturer's Master file. Verification testing was performed as required by the risk analysis for this modification. The results demonstrated that the acceptance criteria were met for Impedance testing."
This indicates that the acceptance criteria and study were related to Impedance testing and biocompatibility of the materials, which are typical for an implanted medical device's physical and material properties, not its diagnostic or performance accuracy based on data analysis.
Therefore, many of the specific questions about "device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth," "training set," and "how ground truth for training set was established" are not applicable or cannot be answered from this document, as they pertain to performance claims that would typically be made for devices involving image analysis, diagnostics, or other AI/ML applications.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Impedance testing met requirements as per risk analysis | Results demonstrated that the acceptance criteria were met for Impedance testing. |
| Biocompatibility of materials | Biocompatibility testing of the material is provided in the manufacturer's Master file; combined with verification testing, it demonstrates no significant safety or effectiveness questions. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not applicable in the context of device performance as described for an AI/ML device. The testing described is non-clinical verification testing of physical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The testing described focuses on physical and material properties (impedance, biocompatibility), not interpretation of data requiring expert ground truth in a clinical sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. No adjudication method for a test set of clinical data is mentioned.
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:
- No MRMC comparative effectiveness study was done. This device is a receiver for a spinal cord stimulator, not an AI/ML-assisted diagnostic device for human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical component of an implanted system; it does not have an "algorithm only" performance separate from the overall system and its function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical ground truth for AI/ML. The "ground truth" for the non-clinical testing would be established engineering or material science standards and specifications for impedance and biocompatibility.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML model that is "trained."
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).