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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 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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