Search Results
Found 2 results
510(k) Data Aggregation
(267 days)
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.
Ask a specific question about this device
(99 days)
This 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 system is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
This submission will add 4 stimulation contact options to the predicate Nalu Neurostimulation System (also referred to as the "Nalu PNS System"). The Nalu PNS System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu PNS System incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu PNS System may be implanted following a successful trial period using the Nalu PNS trial system.
The leads that were cleared with the Nalu PNS System featured 8 stimulation contacts. This submission will provide an optional use of leads with 4 stimulation contacts.
This document is a 510(k) premarket notification for a medical device called the "Nalu Neurostimulation System for PNS" (specifically, the 4-contact version). The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This document does NOT present a study that proves the device meets specific acceptance criteria through clinical performance data. Instead, it argues for substantial equivalence based on non-clinical performance testing because the changes are considered minor.
Therefore, many of the requested items related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" here are demonstrating substantial equivalence through non-clinical testing.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to a predicate device, primarily the Nalu Neurostimulation System (K183579). This is achieved by showing that the new device (4 Contact PNS System) has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The document demonstrates this through comparative tables and statements rather than a traditional pass/fail clinical study.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (4 Contact PNS System) |
|---|---|
| Intended Use: Same as predicate. | Same: Indicated for pain management in adults with severe intractable chronic pain of peripheral nerve origin. Not for craniofacial region. Trial devices for stimulation (max 30 days). |
| Technological Characteristics: Similar to predicate, with differences not affecting safety/effectiveness. | Differences: - Number of Electrodes: 4 (vs. 8 in primary predicate). - Lead Length: 25 cm, 40 cm (vs. 40 cm, 60 cm in primary predicate). - Electrode Array Length: 21 mm (vs. 52 mm in primary predicate). - Electrode Spacing: 3.0 mm (vs. 4.0 mm in primary predicate). - Cable Features: Coiled Wires (vs. Multilumen tube in primary predicate). - Lead Anchor: Integrated Lead Tines (vs. Separate molded silicone anchor with Ti locking mechanism in primary predicate). Performance: All differences are stated to "not affect safety and effectiveness of intended use" and are within parameters of other reference devices. Tested through non-clinical means. |
| Therapeutic Attributes: Same as predicate. | Same: All parameters like pulse frequency, pulse width, current/voltage regulation, output current/voltage, waveform, pulse shape, maximum phase charge/density, net charge, average phase power/density, pulse delivery mode, current path options, software level of concern, program cycle, pulse pattern, dosage time, transmit frequency are identical to the predicate (K183579). |
| Biocompatibility: Meet standards. | Met: Same biocompatibility reports as predicate supported this device. Materials and processes previously assessed. |
| Sterilization: Meet standards. | Met: Ethylene Oxide sterilization, same as predicate. |
| Electrical & Mechanical Performance: Meet specifications, safe, and effective. | Met: Verification testing included electrical and mechanical tests. Validation, performance, and usability testing demonstrated device meets user needs. Conforms to applicable standards (ISO 14708-1, ISO 14708-3, IEC 62366-1, EN ISO 14971, ISO 11607, ISO 11135-1, CISPR 11). |
| Software Level of Concern: Moderate. | Met: Same as predicate (moderate). |
| Human Factors and Usability: Tested and met. | Met: Testing performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on non-clinical performance testing (bench testing, verification, validation, biocompatibility) and a comparative analysis to a predicate device, as opposed to a clinical test set with a specific sample size of patients/cases.
- Data Provenance: Not applicable. There is no clinical data from patients/cases mentioned. The testing is internal (Nalu Medical) and presumably took place in the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. As there is no clinical test set requiring ground truth establishment by experts (e.g., for disease diagnosis or outcome evaluation), this information is not provided nor needed for this type of submission.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or human interpretation requiring adjudication.
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 device is an implanted neurostimulator, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or is relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
- For Non-Clinical Testing: The "ground truth" implicitly used for non-clinical testing (electrical, mechanical, biocompatibility, sterilization) is based on established engineering principles, international standards (e.g., ISO, IEC, CISPR), and pre-defined specifications/tolerances for the device's performance. For biocompatibility, it's compliance with ISO 10993-1. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning/AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Ask a specific question about this device
Page 1 of 1