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The Neuspera Nuity™ System (NNS) 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 Neuspera Nuity™ System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.

The Neuspera Nuity™ System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The System consists of an implantable pulse generator (IPG), electrode array, surgical implant tools, wireless worn transmitter, clinician programmer, a patient controller, and undergarments. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.

Same as the predicate, the Neuspera Nuity™ System utilizes pulsed electrical current to create an energy field that acts on the targeted nerve to inhibit the transmission of pain signals to the brain. The Neuspera Nuity™ System may also be used during the trial period before recommendation for permanent implant.

The Neuspera Nuity™ System (NNS) is comprised of the following components: Neuspera Implanted Pulse Generator (IPG) Or Neuspera Implanted Microstimulator, Electrode Array, Surgical/Implant Tools, Externally Worn Wireless Transmitter, Clinician Programmer and Patient Controller.

The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantifiable measure. Instead, the document is an FDA 510(k) clearance letter and summary, primarily focusing on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and safety aspects.

Therefore, many of the requested categories cannot be filled as they would relate to a clinical or performance study of the device's diagnostic or therapeutic effectiveness, which is not detailed in this document. The information provided is mainly related to bench testing, engineering comparisons, and biocompatibility.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria for performance metrics (e.g., pain reduction scores, successful stimulation rates) nor does it provide a clinical study to report on these. The closest information available is a comparison of technological characteristics to a predicate and reference device, implying that meeting or being comparable to these characteristics is a form of acceptance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-clinical testing activities" including visual tests, dimensional measurement tests, tensile tests, mechanical tests, electrical tests, EMC tests, and MRI tests. These are bench tests, not clinical studies with patients. Therefore, clinical "sample size" and "data provenance" (country/retrospective/prospective) are not applicable to the non-clinical testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The document refers to non-clinical (bench) testing and substantial equivalence, not a clinical study involving expert interpretation or "ground truth" establishment for diagnostic or therapeutic outcomes in patients.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no clinical "test set" in the context of expert adjudication described in the document.

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 is not applicable. The device is a neurostimulation system for pain management, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

This is not applicable. The device is a physical neurostimulation system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable in the context of a clinical performance study. For the non-clinical tests mentioned (e.g., electrical, mechanical, biocompatibility), the "ground truth" would be established by validated test methods and reference standards, rather than expert consensus or pathology data from patients.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable, as there is no training set for an AI/ML algorithm described in the document.

In summary:

The provided document is an FDA 510(k) clearance, which focuses on demonstrating substantial equivalence to a previously cleared predicate device. It primarily relies on non-clinical (bench) testing, engineering comparisons, and adherence to recognized standards to assure safety and effectiveness. It does not contain a detailed report of a clinical performance study with specific acceptance criteria, sample sizes for patient data, expert adjudication, or AI/ML algorithm validation.

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