(365 days)
The Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.
The Vesta RF Cannula consists of an insulated cannula with an active tip for use in radiofrequency heat lesion procedures for the relief of pain. It is designed to be used with compatible pain management generators and probes that have a maximum voltage rating less than or equal to 280 V. The Vesta RF Cannula is sterilized and intended for single use only.
The information provided is about the Biomerics Vesta RF Cannula, cleared under K190259, which is a medical device and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable.
However, I can provide the acceptance criteria and study information that was conducted for this device. The regulatory submission primarily relies on bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance (Not applicable for AI/ML device studies)
The device, the Vesta RF Cannula, is a non-AI medical device. Its performance is demonstrated through meeting various industry standards for physical characteristics, sterilization, and biocompatibility, rather than metrics like sensitivity, specificity, or AUC as would be seen in an AI study.
Table of Acceptance Criteria and Reported Device Performance:
| Standard/Test | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| ISO 6009 (Needle Diameter) | Compliance with ISO 6009 standard | Passed |
| ISO 9626 (Cannula Verification) | Compliance with ISO 9626 standard | Passed |
| ISO 7864 (Needle Tip Inspection) | Compliance with ISO 7864 standard | Passed |
| ISO 80369-7 (Luer Acceptance) | Compliance with ISO 80369-7 standard | Passed |
| ISO 15223-1 (Label Proof Approval) | Compliance with ISO 15223-1 standard | Passed |
| ISO 11135, ISO 10993-7, ISO 11138-2 (Sterilization Assessment) | Compliance with relevant ISO standards for sterilization and residuals | Passed |
| ISO 11607-1 (Stability and Aging Assessment) | Compliance with ISO 11607-1 standard for packaging and shelf-life | Passed |
| Biocompatibility Testing | ||
| Irritation – Intracutaneous (Pooled Blue/Green Hub) | No significantly greater biological reaction than control | Non-irritant |
| Sensitization – Kligman Maximization (Pooled Blue/Green Hub) | No reaction at challenge (0% sensitization) | Non-sensitizer |
| Cytotoxicity – MEM Elution (Blue Hub) | No reactivity (Grade 0) | Non-cytotoxic |
| Cytotoxicity – MEM Elution (Green Hub) | No reactivity (Grade 0) | Non-cytotoxic |
| Systemic Toxicity (Blue Hub) | No clinical signs consistent with toxicity | Non-toxic |
| Systemic Toxicity (Green Hub) | No clinical signs consistent with toxicity | Non-toxic |
| EO Residuals | Below allowable limits established in ISO 10993-7 Section 4.3 for limited exposure device (≤24 hours) | EO sterilization is appropriate |
| Material Mediated Pyrogen | Pyrogenicity risk assessed and found acceptable | Non-pyrogenic |
Since this is a non-AI/ML device, the following points are largely inapplicable or have no information provided in the given document.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable for an AI/ML test set. For bench and biocompatibility testing, the sample sizes are determined by the respective ISO or test standards. These typically involve a small number of samples for physical and chemical tests (e.g., a few units per test).
- Data Provenance: Not applicable. The tests are bench and lab-based studies performed to evaluate device characteristics, not clinical data.
-
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):
- Not applicable as this is a non-AI/ML device. Ground truth is established by objective measurements against engineering specifications and industry standards for physical and chemical properties.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is a non-AI/ML device. Performance is determined by objective measurements and standard compliance.
-
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 device is an RF cannula, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for its safety and effectiveness is established by compliance with recognized international standards (ISO, IEC, ASTM) for material properties, sterilization, physical dimensions, and biocompatibility. This involves objective measurements and qualitative assessments (e.g., "non-irritant," "non-cytotoxic") based on established laboratory protocols.
-
The sample size for the training set:
- Not applicable. This is a non-AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. This is a non-AI/ML device.
§ 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).