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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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