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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 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:

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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 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.

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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 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.

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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.

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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 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 Relievant RFG is a universal AC powered, microcontrolled, 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. RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System are used with the Relievant RFG.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Relievant Medsystems RF Generator:

The provided document describes the Relievant Medsystems RF Generator (RFG), a radiofrequency lesion generator. The acceptance criteria and testing detailed are primarily non-clinical performance tests aimed at demonstrating the device's substantial equivalence to a predicate device, rather than clinical efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical performance testing, primarily bench testing and software validation. Therefore, there are:

• No "test set" in the traditional sense of patient data.
• No human "sample size" for these performance tests.
• The data provenance is laboratory testing of the device itself against established medical device standards and internal company requirements.

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

Since the testing described is non-clinical (electrical, mechanical, software, etc.), the "ground truth" is established by adherence to recognized medical device standards and internal specifications. This means:

• No external human experts were used to establish a "ground truth" for a patient-based test set.
• The "ground truth" is derived from engineering specifications and regulatory standards. Presumably, internal engineers and quality personnel with relevant expertise in these standards conducted and verified the testing.

4. Adjudication Method for the Test Set

Given that the performance testing is non-clinical and based on objective measurements against standards:

• There was no adjudication method (like 2+1 or 3+1 consensus) as this is typically applied to subjective human interpretation of patient data or images.
• The results are either a "Pass" or "Fail" based on whether the device meets the defined quantifiable specifications of the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done.
• The device described is an RF Generator, a piece of medical hardware. It does not involve AI or human-in-the-loop performance improvement with AI assistance.
• The document explicitly states: "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed."

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

• No standalone (algorithm-only) performance was done.
• As noted above, this device is hardware (an RF generator) and does not involve an algorithm for diagnostic or interpretative purposes.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" used was:

• Engineering Specifications and Recognized Medical Device Standards: These include IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, IEC 60601-1-6, IEC 62366-1, and FDA guidance documents for software and human factors.
• Relievant Specified Requirements: Internal requirements set by the manufacturer for mechanical testing.

8. The Sample Size for the Training Set

• Not applicable. This document describes non-clinical performance testing of a hardware device (RF Generator). There is no "training set" in the context of machine learning or AI that would produce diagnostic results.

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

• Not applicable. As there is no training set mentioned or implied for this medical device, there is no ground truth established for it.

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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 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

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 System is comprised of two basic, sterile, single use components, both of which are currently cleared for marketing via 510(k).

• The Intracept Easy Access Instrument Set (Instrument Set) is an instrument kit containing trocars, cannulas and guides that provide access to the intended site of radiofrequency (RF) ablation.
• The Intracept Flexible Bi-Polar RF Probe (RF Probe) conducts RF energy to the target location.
  Additionally, a commercially available, legally marketed RF Generator provides RF energy to the RF Probe. An Interconnect Cable is provided to connect the RF Generator. The only RF Generator currently recommended for use with the Intracept System is the Stockert Neuro N50 (K070336).
  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 Instrument Set, a minimally invasive, "transpedicular approach" is used to allow the placement of a cannula into the vertebral body, and a path or channel is created 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 where it enters the vertebral body. This nerve has been identified as a proprioceptive sensory nerve with innervation of the vertebral endplates.

This document describes the Intracept Intraosseous Nerve Ablation System, which is used for the relief of chronic low back pain. The acceptance criteria and supporting studies are presented, though not in the format of a typical AI device study.

Here's an analysis of the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format alongside specific numerical performance targets for an AI device. Instead, it describes performance in terms of "PASS" for various tests and clinical efficacy for the medical device itself.

Since this is not an AI device, but a physical medical device, the acceptance criteria are related to safety, biocompatibility, electrical safety, mechanical integrity, sterilization, and clinical effectiveness. The performance is reported as meeting these criteria.

Table of Acceptance Criteria and Reported Device Performance (Non-AI Device)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Clinical Study - Test Set):
  • Pilot Study: Seventeen patients.
  • Pivotal Randomized, Double-Blind, Sham Controlled Clinical Study: 225 patients.
    • Intention-To-Treat (ITT) population: 144 in Intracept arm, 77 in Sham arm.
    • Per Protocol (PP) population: 128 in Intracept arm, 77 in Sham arm.
• Data Provenance: The document does not specify the country of origin of the data. The clinical studies were prospective, as indicated by the description of a randomized, double-blind, sham-controlled clinical study with follow-up.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes a physical medical device (Intracept Intraosseous Nerve Ablation System) and its clinical efficacy, not an AI device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" here is the patient's self-reported pain and disability scores (ODI), which are clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the document describes a clinical trial evaluating the efficacy of a medical device based on patient-reported outcomes (ODI scores) and not an AI device that requires adjudication of algorithmic outputs against expert opinions. The clinical trial was randomized and double-blind, with data analysis determining the efficacy.

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

This is not applicable as the document describes a physical medical device and its direct clinical effectiveness study, not an AI device or an MRMC study.

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

This is not applicable as the document describes a physical medical device and its clinical effectiveness, not a standalone AI algorithm. The Intracept System is a medical procedure performed by a clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical performance testing, the "ground truth" or primary measure of effectiveness was the patient's self-reported outcomes data, specifically the Oswestry Disability Index (ODI) Total Score. This index measures disability due to low back pain. The improvement in this score over time, compared to a sham control, served as the primary clinical ground truth.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device and its clinical efficacy, not an AI device that requires a training set. The device itself (RF Probe, Instrument Set) undergoes engineering and performance testing, but there's no "training set" in the machine learning sense.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

The Relievant INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The device is a modification to the Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set incorporating upgraded access and deployment instrumentation. The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lesions in soft tissue. The Instrument Sets are used to provide access to the target tissue.

The provided text describes a Special 510(k) Premarket Notification for the Relievant INTRACEPT Flexible RF Probe and Easy Access Instrument Set. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a comprehensive study that proves the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance:

The document states: "The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set were tested and compared to the predicate device. Ex vivo and in vitro data demonstrated that the INTRACEPT Easy Access Instrument Set achieves RF Probe placements with less procedural complexity and improved ergonomics, which may result in reduced overall procedure time and more efficient instrument exchange. The test data gathered demonstrate that this device is substantially equivalent to the predicate device. No new safety or effectiveness issues have been raised."

Therefore, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device (Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set) in terms of:

• Design
• Materials
• Function
• Intended Use
• Safety
• Effectiveness

The reported device performance indicates that the new instrument set offers:

• Less procedural complexity
• Improved ergonomics
• Potential for reduced overall procedure time
• More efficient instrument exchange

Table of Acceptance Criteria and Reported Device Performance (based on available information):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states "Ex vivo and in vitro data". This indicates laboratory testing, not clinical studies involving human patients. It does not specify sample sizes, country of origin, or whether the ex vivo data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Given that the testing was ex vivo and in vitro, "ground truth" would likely be established through engineering specifications, physical measurements, and comparison to the predicate device's measured performance in controlled settings, rather than expert clinical consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided.

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:

This device is an RF probe and instrument set for thermal coagulation of soft tissues, not an AI or imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not applicable.

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

This device is not an algorithm. Performance was assessed on the physical device and its components, primarily through ex vivo and in vitro testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given the nature of the device and the specified testing (ex vivo, in vitro), the ground truth for this type of submission would typically be based on:

• Engineering specifications and measurements: Performance metrics like power output, lesion size, temperature control, mechanical strength, and material biocompatibility.
• Comparison to predicate device performance: Direct comparative measurements against the established predicate device in controlled laboratory settings.
• Functional testing: Demonstrating the device performs its intended mechanical and electrical functions as designed.

8. The sample size for the training set:

This refers to a training set for machine learning models, which is not applicable to a physical medical device like an RF probe.

9. How the ground truth for the training set was established:

Not applicable, as this is not a device based on machine learning.

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The INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set 1s ıntended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues

The Relievant INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Sets are used in comunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lessons 11 soft tissue The device is a modification to the Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set to incorporate a curved instrument set and a more flexible tip of the radiofrequency probe The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lessons in soft tissue The Instrument Sets are used to provide access to the target tissue

Here's an analysis of the provided text regarding the acceptance criteria and study for the INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set:

Summary of Acceptance Criteria and Device Performance

Study Details

• 1. A table of acceptance criteria and the reported device performance: (Provided above)

• 2. Sample size used for the test set and the data provenance:

  • Sample Size: Not explicitly stated. The document mentions "In vivo data," implying animal or human subject testing, but does not provide specific numbers of subjects or cases.
  • Data Provenance: "In vivo data" is mentioned, suggesting prospective experimental data collected for the purpose of this submission. The country of origin is not specified.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • This information is not provided in the given text. Establishing ground truth typically involves expert assessment, but the summary focuses on direct comparison of lesion characteristics.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • This information is not provided in the given text.

• 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:

  • No MRMC study was done. This device is a medical instrument (RF probe), not an AI diagnostic or assistance tool, so such a study would not be applicable.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This is a physical medical device, not a software algorithm. The "performance" refers to its ability to create lesions, not a diagnostic output.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • The "ground truth" implicitly refers to the characteristics of the lesions created. This would likely be determined through direct measurement and observation of the lesions, possibly via histological analysis (pathology) or imaging, to compare their size and other clinically relevant features to those created by the predicate device. The document states "In vivo data demonstrated that... creates clinically relevant lesions that are equivalent in size," suggesting direct measurement was the basis.

• 8. The sample size for the training set:

  • Not applicable. This device is hardware; there is no "training set" in the context of machine learning. The device itself is "trained" through its design and manufacturing process, and tested directly.

• 9. How the ground truth for the training set was established:

  • Not applicable. As above, there is no training set for a hardware device.

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The INTRACEPT Bi-Polar RF Probe and Instrument Set is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

The Relievant INTRACEPT Bi-Polar RF Probe and Instrument Sets are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lesions in soft tissue. The Instrument Sets are used to provide access to the target tissue and are available in a Standard Length and an Extra Length version.

The provided 510(k) summary for the INTRACEPT Bi-Polar RF Probe and Instrument Set includes limited information regarding detailed acceptance criteria and a comprehensive study report. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance validation with specific acceptance criteria.

However, based on the available information, here's a breakdown:

1. Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not specify quantitative acceptance criteria (e.g., a specific percentage deviation for lesion size or specific dimensions). The equivalence is stated qualitatively.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: Not explicitly stated. The document only mentions "In vivo data."
• Data Provenance: Not explicitly stated. Given it's "In vivo data," it implies animal or human testing. However, the country of origin and whether it was retrospective or prospective is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable/Not provided. The study focuses on demonstrating physical equivalence to predicate devices, primarily through lesion size, rather than diagnostic accuracy requiring expert interpretation of results.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't the primary focus here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. The submission does not describe any study involving human readers or comparative effectiveness with or without AI assistance. The device is a medical instrument for thermal coagulation, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance assessment was done, but it's for the device's physical function, not an algorithm. The "In vivo data" on lesion creation and the comparison to predicate devices represent the standalone performance of the INTRACEPT system in achieving its intended function (thermal coagulation). This is not an algorithm in the typical AI sense, but rather the device itself performing its designated function.

7. Type of Ground Truth Used

• Physical measurement/comparison: The ground truth for the "in vivo data" regarding lesion size would most likely involve direct measurement (e.g., pathology, imaging, or gross examination) of the lesions created by both the INTRACEPT device and the predicate device. The comparison then establishes equivalence.

8. Sample Size for the Training Set

• Not applicable/Not provided. This device is not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense. The development of the device would involve engineering, bench testing, and optimization, but not typically a data training set like AI.

9. How Ground Truth for the Training Set Was Established

• Not applicable/Not provided. As stated above, there is no training set for this type of device.

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