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510(k) Data Aggregation
(267 days)
Freedom Peripheral Nerve Stimulator (PNS) System
The Freedom Peripheral Nerve Stimulator (PNS) System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Freedom Trial Lead Kit is only to be used in conjunction with the Freedom Neurostimulator Kit. The trial devices are solely used for a trial stimulation period (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Freedom PNS System uses HF-EMC (High Frequency Electromagnetic Coupling) neurostimulation technology to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Freedom PNS System is comprised of a two-component implantable neurostimulator, an externallyworn transmitter, and WaveCrest software used to set patient-specific stimulation programs. The system's mechanism of action relies on programmable pulsed electrical current to create an energy field that acts on the targeted peripheral nerve to inhibit the transmission of pain signals to the brain. The two-component neurostimulator, comprised of an electrode array and a separate receiver, are surgically connected and anchored within two separate incisions, including creation of a subcutaneous pocket. The stimulation program is adjusted as needed to provide pain relief for the patient. The purpose of this submission is to modify the indications for use for the existing system (K171366) to include craniofacial applications.
The Freedom PNS System is a single-use, prescription-only system, to be implanted by an appropriate clinician, such as a neurosurgeon, interventional pain physicial surgeon or orthopedic surgeon.
The provided text describes the acceptance criteria and the study conducted for the Freedom Peripheral Nerve Stimulator (PNS) System (K233162) to support the expansion of its indications for use to include craniofacial applications.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Effectiveness Endpoint | A statistically significant proportion of patients in the active treatment group demonstrate significant pain relief (at least 50% reduction) at 3 months compared to baseline, and this is superior to the deactivated control device. | The study showed that "continued treatment with the subject device is superior to the deactivated control device in the proportion of patients with significant (at least 50%) pain relief at 3 months compared to baseline and, thus, the primary effectiveness endpoint was met." |
| Primary Safety Endpoint | The proportion of patients with serious adverse events by 3 months is less than 30%. | The treatment with the subject device was shown to be safe, "passing the safety hypothesis test by demonstrating the proportion of patients with serious adverse events by 3 months was less than 30%." Specifically, "None of the 60 subjects who had implanted devices (Treatment or Control groups) had serious adverse events." |
| Secondary Endpoints | Not explicitly stated in the provided text, but mentioned as having been met. | "The study met its primary effectiveness, primary safety, and secondary endpoints." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 60 patients were implanted with the Freedom® PNS system. Of these, 58 completed the 7-day confirmation visit. 56 of these 58 responders were randomized to either the Active (Treatment group) or Deactivated (Control group).
- Treatment/Active group: 28 patients
- Control/Deactivated group: 28 patients
- Data Provenance: The study was a "multi-center randomized clinical trial." The country of origin is not specified in the provided text, but "clinical data" and "multi-center randomized clinical trial" imply prospective data collection in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study described is a clinical trial assessing the effectiveness of a pain management device. The "ground truth" for effectiveness in this context is self-reported pain relief from the patients themselves, and safety is determined by the occurrence of serious adverse events. Therefore, there's no mention of a traditional expert panel establishing "ground truth" in the same way it would be for, say, image interpretation. The efficacy is based on patient outcomes as measured against the specified endpoints.
4. Adjudication Method for the Test Set
Not applicable in the context of this clinical trial for device effectiveness and safety endpoints. The assessment of pain relief and adverse events would typically follow pre-defined clinical protocols and criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study is a randomized controlled trial comparing the device's effectiveness (active stimulation) against a control (deactivated device) in patients.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Freedom PNS System is a physical implanted medical device that requires human implantation and patient interaction (wearing an external transmitter) to function. Its "performance" is assessed through clinical outcomes in patients, not as a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth for effectiveness was established by patient-reported pain relief (at least 50% reduction compared to baseline). The ground truth for safety was established by the occurrence of serious adverse events.
8. The Sample Size for the Training Set
Not applicable. This is a clinical trial for device approval/expanded indication, not an AI/ML algorithm development where data sets are typically split into training and test sets in that manner. The described study is the clinical evidence used to support the device's efficacy and safety for its intended use.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the context of an AI/ML algorithm. The clinical data from the trial serves as the evidence for the device's performance.
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