(87 days)
The StimQ 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 StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. 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.
The StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System (System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A, Freedom-4A or StimQ), receiver component (Receiver/RF Stylet), and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for diagnostic or screening devices. Instead, it details a 510(k) premarket notification for a medical device (StimQ Peripheral Nerve Stimulator System) seeking substantial equivalence to legally marketed predicate devices.
The document primarily focuses on demonstrating that the StimQ PNS System is as safe and effective as its predicate devices, leveraging non-clinical performance data and showing identical or similar technological characteristics and materials.
Here's a breakdown based on the information available and what is not present:
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Table of acceptance criteria and the reported device performance:
- The document does not provide a table of acceptance criteria with corresponding reported device performance metrics in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
- Instead, it lists various non-clinical tests conducted (e.g., thermal shock, leakage current, mechanical testing, MRI compatibility, ingress of water, electromagnetic compatibility) against recognized standards (e.g., AAMI ANSI ISO 14708-3, ASTM F2182-11a, IEC 60601-1, IEC 60529, IEC 60601-1-2). The "reported device performance" for these tests is generally stated as "passed all criteria," "complies with design requirements," "no irreversible damage," or "fully functional."
- Example (from text, not a structured table):
- Acceptance Criteria (implicit from standard): Protection from temperature change ("functional" / "safe rating" / "no physical damage" / "fully operational").
- Reported Device Performance: "The Stimulators were functional, receiving a safe rating following post visual inspection and passed the change of temperature testing." and "The SWAG met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational."
- Example (from text, not a structured table):
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Sample sized used for the test set and the data provenance:
- The document does not specify sample sizes for the non-clinical tests in terms of number of devices tested. It refers generally to "all tested paths for all tested samples" or "any stimulator samples" or "all tested stylets in all tested stimulator samples."
- The data provenance is non-clinical testing, performed by the manufacturer, leveraging data from previously cleared devices (K170141, K152178, K150517, K160600, K162161, K141399). This appears to be retrospective in terms of referencing prior submissions, and laboratory/bench testing rather than patient clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as there is no diagnostic test or image interpretation involved requiring expert ground truth for a test set. The tests are engineering and biological safety assessments.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as there is no diagnostic test or image interpretation involved.
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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 information is not applicable. The device is an implanted peripheral nerve stimulator for pain management, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a physical medical device, not an algorithm. Performance testing was done on the device's physical and electrical characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" or reference is adherence to established industry standards and regulatory requirements (e.g., ISO, ASTM, IEC standards) and the product's own design specifications. For biocompatibility, it's ISO 10993-1.
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The sample size for the training set:
- This is not applicable as the device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- This is not applicable as the device is not an AI/ML algorithm that requires a training set.
In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence for a medical device by referencing extensive non-clinical testing performed against established standards and leveraging data from previously cleared predicate devices. It does not involve diagnostic performance metrics, clinical studies, or AI/ML components requiring the type of acceptance criteria and study details requested in the prompt.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).