(240 days)
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)
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | PASS (Same materials, same testing as for predicate device.) |
| Sensitization (ISO 10993-10) | PASS (Same materials, same testing as for predicate device.) | |
| Acute Systemic toxicity (ISO 10993-11) | PASS (Same materials, same testing as for predicate device.) | |
| Intracutaneous Reactivity (ISO 10993-10) | PASS (Same materials, same testing as for predicate device.) | |
| Ethylene Oxide (EtO) residuals (ISO 10993-7) | PASS (Same materials, same testing as for predicate device.) | |
| Electrical Safety | IEC 60601-1 (General requirements for basic safety and essential performance) | In compliance (Same as for predicate device) |
| IEC 60601-1-2 (Electromagnetic compatibility) | In compliance (Same as for predicate device) | |
| IEC 60601-2-2 (Particular requirements for basic safety and essential performance of high frequency surgical equipment and accessories, including external surface temperature, dielectric, and leakage current) | PASS (Same as for predicate device) | |
| Physical/Mechanical | Intracept RF Probe: Dimensional specifications, Corrosion (ISO 10555-1), Transit (ASTM D4169-09), Bubble Test (ASTM F 2096-04), Seal Peel Test (ASTM F88/F88M-09), Mechanical Testing (Bend/Buckling, Handle Tensile, Distal tip Tensile) | All PASS |
| Intracept Easy Access Instrument Set: Dimensional specifications, Corrosion (ISO 10555-1), Transit (ASTM D4169-09), Bubble Test (ASTM F 2096-11), Seal Peel Test (ASTM F88/F88M-09), Mechanical Testing (Introducer Cannula Tensile & Torque, Trocar Tensile & Torque, Curved Cannula Tensile & Torque, J-Stylet Tensile & Torque, Straight Stylet Tensile, Stopper Ring Torque) | All PASS | |
| Sterilization | Sterilization Validation (ISO-11135-2014) | PASS (Sterility assurance of 10^-6) |
| System Performance | Device Compatibility (Probe and Instrument Set compatibility, Probe and Cable/RFG compatibility) | PASS (Specs met per Product Specifications; includes dimensional measurements, performance, and simulated use testing) |
| Temperature Accuracy | PASS (Accuracy verified by measurements and performance testing) | |
| Lesion (Measured RF Lesion Size in Tissue Model, Bovine In Vivo, Thermal distribution, Lesion size based on Thermal Dosimetry and histology) | PASS | |
| Clinical Efficacy | Primary Endpoint: Change from Baseline in Oswestry Disability Index (ODI) at Month 3 (Per-Protocol Population) - LS Mean Improvement | Intracept Arm: -20.5 points; Sham Arm: -15.2 points. Difference from Sham System in LS Mean: -5.3 (p=0.019), showing statistical superiority for Intracept. |
| ODI Responder Rates (percentage of patients with >10-point MCID improvement) at 3 months (Per-Protocol Population) | Intracept Arm: 75.6% (96/127); Sham Arm: 55.3% (42/76). This difference indicates a higher clinically meaningful improvement rate with Intracept. |
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.
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).