FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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 6 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.

Device Description

The INTRACEPT® Intraosseous Nerve Ablation System is comprised of two sterile, single use components:

The INTRACEPT Access Instruments include trocars, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. This submission describes modifications to the Access Instruments to improve ease of use compared to the predicate. Easy Access Instrument Set.
The INTRACEPT Flexible Bi-Polar RF Probe conducts RF energy to the target location. There have been no changes to this component; therefore, there is no impact on RF ablation.
Additionally, a commercially available, legally marketed, RF Generator that has been confirmed by Relievant to be compatible, provides RF energy to the RF Probe. An Interconnect Cable connects the RF Probe to the RF Generator.
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 is placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. An RF Probe is then placed into this channel at the terminus of the basivertebral foramen, and controlled RF energy is delivered to destroy the basivertebral nerve. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the INTRACEPT Intraosseous Nerve Ablation System. It describes the device, its intended use, and the rationale for its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This 510(k) submission primarily focuses on the INTRACEPT Access Instruments and their modifications. The manufacturer claims substantial equivalence to a previously cleared device, asserting that the changes improve ease of use without impacting safety or effectiveness. No clinical performance testing was performed for this submission, as substantial equivalence was deemed achievable through non-clinical testing and device comparison.

1. Table of Acceptance Criteria and Reported Device Performance

Category / Test	Acceptance Criteria (What was measured against)	Reported Device Performance (Results)
Material Biocompatibility	Compliance to ISO 10993 standards for tissue/bone/dentin contact 1.0 lbs per ASTM F88/F88M-15.	PASS
Mechanical (Introducer Cannula, Trocar/Bevel, Curved Cannula, J-Stylet, Straight Stylet)	Met all performance testing per Product Specifications (Tensile & Torque). Specific limits not detailed in the table provided.	PASS (Met all performance testing per Product Specifications)
Sterilization	Sterility assurance level of 10-6 per ANSI/AAMI/ISO 11137-1: 2006 and ANSI/AAMI/ISO 11137-2.	PASS
Interface and Primary Operating Function	Devices remained functional without damage and met interface requirements after 6 full deployments.	PASS (Following exposure to 6 full deployments, devices remained functional without damage and met interface requirements.)
Usability	Safe and effective for intended users, uses, and use environments, per IEC 62366-1: 2015.	PASS (Usability testing simulated in sawbones with 16 users of the INTRACEPT Intraosseous Nerve Ablation System (Access Instruments and RF Probe) were safe and effective for intended users, uses and use environments.)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Usability Testing: 16 users were involved in the usability simulation in sawbones.
- For other non-clinical tests (biocompatibility, mechanical, corrosion, etc.), the exact sample sizes (e.g., number of units tested for mechanical strength) are not specified in this summary document, but standard testing practices for these ISO/ASTM standards would imply a statistically relevant number of samples.
Data Provenance: The data is from non-clinical bench testing and simulated use/usability studies conducted by Relievant Medsystems. There is no information about the country of origin of the data beyond it being generated by the applicant company (Relievant Medsystems, Redwood City, CA, USA). All data is prospective as it was generated specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

No external human "experts" established ground truth for the technical performance of the device. The acceptance criteria for the non-clinical tests (material, mechanical, sterilization, etc.) are based on established international standards (ISO, ASTM) and the manufacturer's internal product specifications. The "ground truth" here is compliance with these predefined engineering and safety standards.
For the usability study, "users" (16 of them) participated in a simulated environment. Their qualifications are not specified beyond being "users of the INTRACEPT Intraosseous Nerve Ablation System." It is implied they are medical professionals who would operate such a device. This is not a "ground truth" derived from expert consensus on medical image interpretation, for example.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. For this type of 510(k) submission based on non-clinical testing for substantial equivalence, formal "adjudication" by multiple human reviewers as seen in AI/CAD studies is not performed. The "adjudication" is inherent in the objective measurements against established engineering and biological standards. If a test "passed," it met the objective criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed."
Therefore, there is no effect size given for human readers improving with AI vs. without AI assistance, as AI is not a component of this device, and no human readership study was conducted.

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

Not applicable. This device is a physical medical instrument (ablation system with access instruments), not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on adherence to international consensus standards (ISO, ASTM) for biocompatibility, mechanical properties, sterilization, packaging integrity, and the manufacturer's own product specifications for mechanical performance and interface functionality validated through bench and simulated use testing.
For usability, the ground truth was derived from the observation of simulated use and the assessment of "safe and effective for intended users, uses and use environments" by the manufacturer against IEC 62366-1.
No expert consensus on medical findings, pathology, or clinical outcomes data was used because clinical data was not required for this specific 510(k) submission, which focused on modifications to access instruments for improved ease of use, asserting equivalence to a predicate device.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

Summary

Regulation Number and Section

§ 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).