(92 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 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.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Device performs as intended. | "Subject Device (Intracept System) with additional ablation parameters performs as intended." |
| No new safety and/or efficacy concerns raised by changes. | "does not raise any new safety and/or efficacy concerns when compared to the legally marketed Predicate Device (Intracept System)." |
| Risk profile of additional ablation parameters is acceptable. | "Risk analysis of an additional set of ablation parameters at lower temperature, ramp, and time showed no increase in risk profile." |
| Functional equivalence to predicate device. | "The Subject and Predicate Devices have a functionally equivalent design, with the difference being the introduction of an additional set of 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.
§ 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).