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Moventis PNS 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 Moventis PNS is not intended to treat pain in the craniofacial region.

Moventis PNSTM is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain originating from peripheral nerves. The therapy utilizes pulsed electrical waveforms to create an electrical energy field that acts on afflicted peripheral nerves to alter the transmission of pain signals from those nerves to the brain. Moventis PNS is comprised of percutaneous Implanted Pulse Generator (pIPG) and a preprogrammed External Transmitter (ETx) worn outside the body over the general area of the pIPG to provide signal and power.

This document (K200848) is a 510(k) premarket notification for the Moventis PNS, an implanted peripheral nerve stimulator for pain relief. The submission asserts substantial equivalence to predicate devices, meaning it has the same intended use and similar technological characteristics.

The information provided primarily focuses on non-clinical performance and substantial equivalence to legally marketed predicate devices, rather than a clinical study establishing acceptance criteria and device performance in a traditional sense. The device is cleared based on demonstrating compliance with recognized standards and equivalence to existing devices, not on a new clinical trial that sets and meets specific performance metrics for the Moventis PNS.

Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not directly applicable or explicitly stated as clinical performance data in this regulatory document. However, I can extract the relevant information regarding the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness relative to predicate devices and recognized standards.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance.

The document does not present specific clinical acceptance criteria (e.g., target pain reduction percentages or success rates from a clinical trial) that the Moventis PNS had to meet. Instead, acceptance is based on demonstrating compliance with recognized safety and performance standards for medical devices and showing substantial equivalence to predicate devices. The "reported device performance" in this context refers to the outcomes of non-clinical testing.

• Passed cytotoxicity, sensitization, irritation, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation (4, 8, 13 weeks), and subchronic toxicity tests.
• Materials (Pellethane 55D, Pt-Ir 90:10) have extensive record of chronic and carcinogenic safety.
• ETx is a non-contacting device.
• Meets biological safety and compatibility requirements. |
  | Electrical Safety (IEC 60601-1:2005 + A1:2012) | - ETx demonstrated compliance for electrical safety.
• pIPG prevents direct current density at electrodes above 0.75 uA/mm².
• Withstands dielectric strength testing.
• Meets electrical safety requirements. |
  | Electromagnetic Compatibility (EMC) & Wireless Coexistence (IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014) | - ETx demonstrated compliance for electromagnetic interference and wireless coexistence.
• Moventis PNS met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, and magnetic fields. Operates within test limits with no physical damage and full operation.
• Meets EMC and wireless coexistence requirements. |
  | Usability (IEC 62366:2015) | - ETx demonstrated compliance, meeting acceptance criteria of usability validation plan and mitigating risks.
• Meets usability requirements. |
  | Risk Management (ISO 14971:2019) | - Risks associated with wireless communication mitigated through risk analysis, evaluation, control, and safety by design.
• Product labeling indicates medical procedures contraindicated for use.
• Gradual, long-term material changes do not result in unacceptable risks.
• Risks mitigated as far as possible. |
  | Packaging (ISO 11607-1) | - Verified to protect devices from shock, stacking, vibration, temperature, pressure, and humidity variations.
• Complies with packaging requirements. |
  | Markings (Durability and Legibility Requirements) | - Demonstrates compliance with durability and legibility requirements.
• All requirements and markings clearly identified and viewable.
• Complies with marking requirements. |
  | Sterilization (ISO 14708-3:2017 in compliance with ISO 11135:2014) | - Validated for ethylene oxide (EO) sterilization.
• Verified no unacceptable release of particulate matter at implantation.
• Meets sterilization requirements. |
  | Heating Limits | - Does not exceed heating limits.
• Protects patients from heating harm. |
  | External Influences (Defibrillation, Ultrasound, EMF) | - Demonstrated safe operation in presence of external defibrillation, ultrasound, and electromagnetic fields.
• No irreversible damage following exposure to changes in electric fields.
• pIPG functional after exposure to external defibrillation.
• Demonstrates safety under external influences. |
  | Mechanical Force Test (IEC 60601-1:2005 + A1:2012) | - Passed free-fall tests. No visible damage or functional damage.
• Mechanical testing (tensile, flex, torsion) showed pIPGs comply with mechanical design requirements.
• Meets mechanical force test criteria. |
  | Electrostatic Discharge (ESD) (IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014) | - Demonstrated safe operation following ESD.
• Protects from ESD damage. |
  | Atmospheric Pressure & Temperature Test (IEC 60601-1) | - No change to device specification or damage following exposure to absolute pressure or changes in temperature (including shipping/storage ranges).
• Meets atmospheric pressure and temperature test criteria. |
  | Ingress of Water (IEC 60529) | - Met visual and functional inspection passing criteria. No physical damage, fully operational.
• Satisfies ingress of water requirements. |
  | Particulate Matter (IEC 60529) | - Met visual and functional inspection passing criteria. No physical damage, fully operational.
• Satisfies particulate matter requirements. |
  | Means of Protection, Creepage Distances, Air Clearances (IEC 60601-1) | - Design analysis confirmed system satisfies requirements.
• Complies with protection requirements. |

2. Sample size used for the test set and the data provenance.

The document refers to non-clinical testing rather than a "test set" of patient data. For non-clinical performance and safety testing (e.g., electrical safety, biocompatibility, mechanical testing), the sample sizes are not explicitly stated for each test but would typically involve a sufficient number of units to demonstrate compliance with the relevant standards.

• Sample Size: Not explicitly stated for each non-clinical test, but implied to be sufficient for compliance with each standard.
• Data Provenance: All testing appears to be prospective bench and lab testing conducted by the manufacturer (Micron Medical Corporation) or contracted labs to demonstrate compliance with design requirements and international standards. No patient data (retrospective or prospective) is described as being used for performance evaluation in this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.

This question is not applicable. No clinical "test set" requiring expert-established ground truth was used for this 510(k) submission. The evaluation focused on non-clinical performance and comparison to predicate devices, which relies on engineering and scientific expertise relevant to the standards.

4. Adjudication method for the test set.

This question is not applicable. No clinical "test set" and thus no adjudication method were described.

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.

This question is not applicable. The device is a physical medical device (peripheral nerve stimulator), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.

This question is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used.

For the non-clinical testing, the "ground truth" refers to the established requirements and specifications defined by international standards (e.g., ISO, IEC) and the device's own design inputs. The device's performance was measured against these predefined thresholds and compliance criteria, not against clinical outcomes or expert consensus on patient data.

8. The sample size for the training set.

This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established.

This question is not applicable, as there was no "training set."

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