(63 days)
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 features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System 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 features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of 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 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) premarket notification for the Intracept Intraosseous Nerve Ablation System and its associated RF Generator. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily by clarifying the Indications for Use related to Modic changes on MRI.
Based on the provided text, the device itself is an RF ablation system used to treat chronic low back pain. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission are not about the performance of a new or modified device against specific performance metrics for clinical efficacy or diagnostic accuracy. Instead, the focus is on demonstrating that the clarified indications for use do not alter the substantial equivalence to the previously cleared devices, meaning it does not introduce new questions of safety or effectiveness.
Therefore, the typical structure for describing an AI/ML device's acceptance criteria and proven performance doesn't directly apply here. The device itself is not an AI/ML system, nor is the 510(k) submission primarily presenting a study to prove its performance in a diagnostic or predictive sense. The "proof" in this context is the argument for substantial equivalence without new clinical or non-clinical testing.
Here's an attempt to answer your questions based on what is relevant and stated in the document, acknowledging that many of your specific questions about AI/ML acceptance criteria and testing are not addressed because this is a different type of medical device submission:
Summary of Acceptance Criteria and Device Performance (in the context of a 510(k) for modified Indications for Use):
The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating Substantial Equivalence to the predicate devices (Intracept Intraosseous Nerve Ablation System K180369, K170827 and Relievant RFG K171143), specifically concerning the modification of the Indications for Use statement. The key "performance" here is that the modified Indications for Use do not raise different questions of safety or effectiveness and do not describe a new disease condition or patient population.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion (Implicit for 510(k)) | Reported Device Performance (as argued in 510(k)) |
|---|---|
| No change in device design/technology. | "No design changes were made to the Subject Devices." (Page 7) |
| "Compared to the Predicate Devices (Intracept System and Relievant RFG), there have been no design changes to the Intracept System or the Relievant RFG." (Page 5) | |
| Modified Indications for Use (IFU) do not alter fundamental intended use. | The Intended Use remains: "To ablate the basivertebral nerves of the L3 to S1 vertebrae." (Page 5) |
| Modified IFU do not describe a new disease condition or patient population. | "The modification does not describe a new disease condition or patient population that the Subject Devices are intended to treat." (Page 5) |
| "The modification does not raise different questions of safety or effectiveness." (Page 7) | |
| The modifications clarify features consistent with Type 1 or Type 2 Modic changes (e.g., inflammation, edema, vertebral endplate changes, etc.), aiding clinicians' interpretation of MRI findings, rather than defining new conditions. (Page 5) | |
| Non-clinical performance maintained (due to no design changes). | "No design changes were made to the Subject Devices. Substantial equivalence is not dependent upon non-clinical clinical performance testing." (Page 7) – Implicitly, previous non-clinical data remains valid. |
| Clinical performance maintained (due to no design changes). | "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed." (Page 7) – Implicitly, previous clinical data (if any was required for the predicates) remains valid, and no new clinical questions are raised. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is not based on a new test set of data for performance evaluation in the way an AI/ML device would be. It relies on the substantial equivalence argument, stating no new clinical or non-clinical testing was performed because the device design remained unchanged and the IFU modification did not raise new questions of safety or effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new test set data or formal independent ground truth establishment processes (as would be typical for diagnostic performance studies) are described in this 510(k) submission. The clarification of Modic changes in the IFU is based on existing medical understanding and classification, not a novel ground truth process for a test set.
4. Adjudication method for the test set:
- Not applicable. See point 3.
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:
- Not applicable. This is not an AI-enabled device, and no MRMC study was conducted or presented in this 510(k) for the purpose of demonstrating comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm or software device that performs a diagnostic function. It is a physical medical device (RF ablation system).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No new ground truth derivation was required for this 510(k) submission. The modifications to the Indications for Use reflect an elaboration of existing, clinically recognized characteristics of Modic changes on MRI, which are established medical knowledge.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model described in this submission that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML model described in this submission.
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).