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SCS:
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. 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.

PNS:
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 Nalu Neurostimulation System for PNS 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.

The Nalu Neurostimulation System (referred to as the "Nalu System") incorporates a miniature implantable pulse generator (IPG), powered by an externally worn Therapy Disc device. The Nalu System therapy utilizes pulsed electrical current to create an energy field that acts on peripheral nerves or central nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. This device is intended to be used in the spinal column as well as the peripheral nerves in arm, leg, pelvic and other areas, as is typical of other devices and treatments for the same intended use.

The Nalu System is intended for stimulation of the spinal cord or peripheral nerves for patients experiencing chronic, intractable pain. This system is indicated for pain management in adults who have severe intractable chronic pain, 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.

The Nalu System is comprised of the following components:
• Implantables (there are no proposed changes to these components as previously provided in K221376):
o Implantable pulse generator (IPG; available either as an integrated lead unit or with separately connected lead(s)) – provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site(s).
o Leads – implantable and designed to deliver electrical pulses to the nerves via an array of four (4) or eight (8) cylindrical electrodes at the distal end.
o Surgical and Trial Tools – includes anchors, spoonbill needs, stylets, tearaway introducers, pocket tunneler, torque wrench, IPG insertion tool, straw tunneler; tools to support implantation of lead and IPG.

• Externals, Non-Sterile:
  o Externally worn controllers (for use with the permanent implant) and accessories – includes the Therapy Disc, Adhesive Clip, Wearable Garment, Therapy Disc Charger; houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer (subject of this submission).
  o Externally worn stimulator (for use with the trial lead) and accessories – includes the Trial Therapy Disc; sends signals to the percutaneous leads during the trial period by way of the Electrode Interface Cable (EIC).
  • Software (subject of this submission):
  o Clinician Programmer, Patient Remote Control – used to configure the system parameters; also manages patient records, Therapy Discs and remote controls for patients with the Nalu System; runs on Android and iOS platforms and can be optionally used to control and manage Therapy Discs over a secure Bluetooth® Low Energy connection.

The provided text is a 510(k) premarket notification for the Nalu Neurostimulation System. It details modifications made to an existing device, primarily to its external components and software, and argues for substantial equivalence to a previously cleared predicate device (K221376).

Crucially, this document does not describe a study to prove a device meets acceptance criteria related to efficacy or performance comparable to what would be found in a multi-reader, multi-case (MRMC) study or a standalone algorithm performance evaluation for an AI/ML medical device.

Instead, the "acceptance criteria" and "proof" provided are focused on engineering verification and validation to demonstrate that the modifications to the existing device do not raise new questions of safety or effectiveness, thus maintaining substantial equivalence to its predicate. The device itself is a neurostimulation system for pain relief, not an AI/ML diagnostic tool.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, effect size of human reader improvement, standalone performance, type of ground truth, training set sample size, ground truth for training set) are not applicable to this submission, as it is not for an AI/ML algorithm requiring such performance evaluations.

However, I can extract information relevant to the engineering acceptance criteria and the validation activities performed for the modified device components.

Here's a breakdown of the information that can be extracted from the provided text, and an explanation of why other requested information is not present:

Acceptance Criteria and Device Performance (Engineering/Safety Context)

The document frames its "acceptance criteria" as demonstrating that the modified device's technological characteristics are effectively the same or do not raise different questions of safety and effectiveness compared to the predicate device. The performance is then shown through various engineering and validation tests.

Study Details (Context of Engineering Validation, Not AI Performance)

1. Sample size used for the test set and the data provenance: Not applicable in the context of clinical results from a test set as would be used for an AI/ML diagnostic device. The "test set" here refers to physical units of the modified device and its software undergoing various engineering and software validation tests. Data provenance is not described in terms of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance (e.g., expert consensus on medical images) is not relevant for this engineering and software validation. The "ground truth" for these tests are largely defined by engineering specifications, regulatory standards, and functional requirements.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in studies involving human interpretation or performance, typically for diagnostic accuracy.

4. 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:

   • No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "No clinical testing was performed."
   • This device is a neurostimulation system, not a diagnostic imaging AI/ML device that assists human readers.

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

   • Not applicable in the context of an AI/ML algorithm. The "software testing" mentioned evaluates the software's functional correctness against its specifications, not its standalone diagnostic or interpretive performance.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable for an AI/ML context. For the engineering and software validation, the "ground truth" is adherence to established engineering specifications, industry standards (e.g., ISO, IEC), and regulatory guidance.

7. The sample size for the training set: Not applicable. This submission is for hardware and software modifications to a neurostimulation device, not for an AI/ML model that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set in this context.

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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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Spinal Cord Stimulation (SCS)

This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

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.

Peripheral Nerve Stimulation (PNS)

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.

The Nalu Neurostimulation system has been cleared by the FDA for spinal cord stimulation (SCS; K183047) and peripheral nerve stimulation (PNS; K183579, and K191435) to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system.

The Nalu Neurostimulation system consists of five components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for Spinal Cord Stimulation (SCS) or Peripheral Nerve Stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K183047, K183579, and K191435).

The Nalu Neurostimulation System is a non-AI device, and the provided documentation is a 510(k) submission for substantial equivalence. Therefore, the questions related to AI/algorithm performance, ground truth, training sets, and expert adjudication are not applicable here.

The document discusses the Nalu Neurostimulation System, which is an implantable neurostimulation device for pain relief.

Here's the information extracted based on the provided text, focusing on the device's characteristics and the justification for substantial equivalence, which is the "study" in this context:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) process for substantial equivalence does not typically present a formal "acceptance criteria table" in the same way clinical trials for new devices might. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "performance" in this context refers to the device's technical specifications and intended clinical outcomes, which are asserted to be equivalent to the predicate.

For the Nalu Neurostimulation System (Subject Device), the performance is demonstrated by its substantial equivalence to the predicate and reference devices (K183047, K183579, K191435). The key "acceptance criteria" here implicitly are that the device meets the same safety and effectiveness profiles as the predicate.

Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a 510(k) premarket notification for substantial equivalence. The core of this "study" is a comparison to predicate and reference devices, along with performance testing.

• Justification: The submission asserts that the subject device is substantially equivalent to the predicate (Nalu Neurostimulation System for SCS, K183047) and reference devices (Nalu Neurostimulation System for PNS, K183579 and K191435) because:
  • They are identical with regard to indications for use, performance, and technological characteristics, except for the increased service life of the IPG and the re-usable nature of the Therapy Disc.
  • "All of the physical and therapeutic attributes for the proposed Nalu Neurostimulation System and the predicate devices share the same technological characteristics and have no differences that would impact safety or effectiveness."
  • Risk analysis of the proposed changes (extended IPG service life, reusable Therapy disc) did not raise any questions of safety and effectiveness.
  • Performance testing was conducted by Nalu Medical, Inc. to support the safety and performance, adhering to 21 CFR 820.30, ISO 14971, and ISO 13485:2016. The test results from the predicate device are considered applicable to the subject device for unchanged aspects.

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

The document does not specify a clinical "test set" in the traditional sense of a clinical trial with a defined patient sample size. This is a 510(k) submission based on substantial equivalence, not a new clinical efficacy study. The "test set" for performance is described as "a range of testing to gather data supporting the safety and performance," including:

• No specific patient sample size is mentioned. The comparison is largely based on technical specifications and existing cleared devices.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing mentioned appears to be primarily bench testing and engineering validation (e.g., meeting standards like ISO 14971, ISO 13485) rather than patient data.

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

N/A. This is not a study assessing diagnostic accuracy or involving human interpretation of data for ground truth establishment. It's a review of a neurostimulation device for chronic pain based on its technical features and equivalence to previously cleared devices.

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

N/A. Not applicable to a 510(k) submission for a non-AI neurostimulation device.

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

N/A. This device does not involve AI or human "readers" assessing cases.

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

N/A. This device is not an algorithm or AI system.

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

N/A. Ground truth in the context of diagnostic performance is not relevant here. The "ground truth" for this submission is established through adherence to standards, engineering validation, and comparison to the known safety and efficacy profile of predicate devices.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a training set.

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

N/A. This is not an AI/ML device that requires a training set.

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