Search Results

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 change), and 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, singleuse components: The Intracept Access Instruments include 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 Radiofrequency Generator (RFG). The Relievant RFG is a universal AC powered, microcontroller controlled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. Currently, the Relievant RF Generator (reference device (K171143)) is the only compatible RF generator for use with the Intracept System. The Intracept System uses RF energy to ablate 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 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.

The Relievant Medsystems, Inc. Intracept Intraosseous Nerve Ablation System (K222281) did not undergo a clinical study as substantial equivalence was determined based on non-clinical performance testing. The device is a modification of a previously cleared device (K213836). Modifications were made to the Access Instruments component of the system to improve usability and performance, but the RF Probe remained unchanged.

Here's a summary of the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

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 change), and 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 is comprised of sterile, singleuse 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 Radiofrequency Generator (RFG).
  The Intracept System 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 (BVN). This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

The provided text describes the 510(k) premarket notification for the Intracept Intraosseous Nerve Ablation System. It focuses on demonstrating substantial equivalence to a predicate device, specifically regarding the introduction of an additional set of ablation parameters.

Based on the provided information, the device in question is a medical device for radiofrequency ablation, not an AI/ML powered device. Therefore, many of the requested elements for describing an AI/ML powered medical device, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth for training was established, are not applicable and not present in this document.

The document primarily focuses on demonstrating that the new version of the device, with additional ablation parameters, is substantially equivalent to a previously cleared version. The "acceptance criteria" here are effectively the criteria for establishing substantial equivalence, which is shown through non-clinical performance testing.

Here's an interpretation based on the provided text, recognizing its focus on a hardware device rather than an AI/ML algorithm:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a hardware device (RF ablation system) rather than an AI/ML diagnostic device, the "acceptance criteria" are not reported in terms of standard diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, they are framed around demonstrating safety and efficacy comparable to a predicate device, particularly with the introduction of new ablation parameters.

The key difference for the new device is the addition of ablation parameters:

• New Ablation Parameters: 75° C, 0.5°C/second ramp, 7 minutes (420 seconds) time. The predicate had only 85° C, 1°C/second ramp, 15 minutes (900 seconds).

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

This document does not describe a clinical study with a "test set" of patient data for evaluating an AI/ML algorithm. The "testing" mentioned is "Non-Clinical Performance Testing." This likely refers to in-vitro or bench testing, and potentially animal studies, to validate the device's physical performance, safety, and the effects of the new ablation parameters on tissue.

• Sample Size: Not explicitly stated, as it's non-clinical performance testing, not a clinical trial with a patient test set.
• Data Provenance: Not applicable as it refers to non-clinical testing, not patient data (e.g., retrospective/prospective).

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

Not applicable. The ground truth for a hardware device's performance is typically established through engineering specifications, physical measurements, and biological response studies, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of expert review of data for AI/ML performance.

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

Not applicable. This is a hardware device submission, not an AI/ML algorithm where MRMC studies are relevant for assessing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not applicable. This is a standalone device in the sense that it performs a physical action (ablation), but not a standalone AI algorithm generating an output without human intervention for diagnostic or clinical decision-making purposes.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on non-clinical performance testing. This would involve:

• Engineering specifications and measurements: Ensuring the device delivers RF energy as expected.
• Pre-clinical (in-vitro/ex-vivo/animal) studies: Demonstrating the desired biological effect (ablation leading to cellular necrosis) and safety profile in relevant tissues using the specified parameters.
• Risk analysis: Evaluating potential increases in risk profile with the new ablation parameters.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML model that undergoes a "training set" process.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as it's not an AI/ML model with a training set.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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.

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

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.

Ask a specific question about this device