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The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of two sterile, single-use components:

• . The Intracept Access Instruments include introducers, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation.
• . The Intracept RF Probe conducts RF energy to the target location.
  To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant RF Generator (RFG).
  The Intracept System technique uses RF ablation of the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel at the terminus of the basivertebral foramen and controlled RF energy is delivered to ablate the basivertebral nerve. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

This document is a 510(k) summary for the Intracept Intraosseous Nerve Ablation System (specifically the Intracept RF Probe component), submitted to the FDA by Relievant Medsystems, Inc. It describes the device's technical characteristics and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

The provided text does not contain information about a study that assesses the device's performance against clinical acceptance criteria or involves human readers (MRMC study or standalone study). The device described is a medical instrument used in a surgical procedure, not an AI or imaging diagnostic device that would typically have acceptance criteria based on accuracy, sensitivity, or specificity of interpretation. Instead, the focus of this 510(k) submission is on demonstrating the device's safety and technical performance through non-clinical testing to establish substantial equivalence to a previously cleared predicate device.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set sample size, and ground truth for training set) are not applicable to the information presented in this 510(k) summary.

Here's a breakdown of the relevant information from the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on its compliance with various international standards and internal performance specifications for safety, biocompatibility, and functional integrity. The "reported device performance" indicates that the device met these specifications.

Study Details (as far as applicable)

1. Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical, involving material property tests, durability tests, electrical safety tests, and functional evaluations, rather than a "test set" of clinical data or patient samples.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant here. The ground truth for engineering and biocompatibility tests is established by adhering to recognized international standards and specifications.
3. Adjudication method for the test set: Not applicable. This concept is for clinical studies with expert reviewers.
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 study was not done. This device is a surgical instrument, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone performance study in the context of an algorithm or AI was not done. The non-clinical performance testing evaluates the device's technical specifications and safety.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical testing consists of established international standards (e.g., ISO, ASTM, IEC) and internal engineering specifications for device performance, safety, and biocompatibility. The tests aim to verify that the device's physical and functional properties meet these predefined criteria.
7. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Clinical Performance Testing:
The document explicitly states: "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed."

Conclusion:
The 510(k) submission relies on non-clinical performance testing and a comparison of the device's technical characteristics to a predicate device to demonstrate substantial equivalence, rather than clinical efficacy or diagnostic accuracy.

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