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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 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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