(91 days)
The Cosman RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made.
The Cosman RF Injection Electrodes are used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions of nerve tissue or for use in percutaneous nerve blocks.. The COSMAN CU, CUR, TCD and CCD are temperature sensing RF injection electrodes. The COSMAN CP, CR and CN are non-temperature sensing RF injection electrodes. The Cosman RF Injection Electrodes are available in a variety of lefegths and gauges. The Cosman RF Injection Electrodes are provided sterile packed and are labeled for Single Use Only.
The provided text is a 510(k) Summary for the Cosman RF Injection Electrodes. It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a clinical study for the Cosman RF Injection Electrodes. Instead, the basis for clearance is substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and Effective | "The comparison to the predicate device demonstrates that the Cosman RF Injection Electrodes are safe and effective and are substantially equivalent to the predicate device." "The comparison and testing results in this 510(k) notification show the Cosman RF Injection Electrodes are substantially equivalent to predicate devices and are safe and effective for its intended use." |
| Substantially Equivalent | "The Cosman RF Injection Electrodes have similar physical and technical characteristics to the predicate devices." "The comparison and testing results in this 510(k) notification show the Cosman RF Injection Electrodes are substantially equivalent to predicate devices..." |
2. Sample size used for the test set and the data provenance
The document does not report on a test set sample size or data provenance from a study demonstrating the device's performance through direct human or animal trials. The clearance is based on comparison to predicate devices, which implies that the prior performance of those devices, not a new study, forms the basis of the safety and efficacy argument.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable. The document does not describe a study involving adjudication of a test set.
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
Not applicable. The Cosman RF Injection Electrodes are a medical device (electrode/probe), not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As stated above, this is a medical device, not an algorithm.
7. The type of ground truth used
Not applicable. The safety and effectiveness are established through substantial equivalence to predicate devices, not through a study involving a defined ground truth like pathology or outcome data for this specific device.
8. The sample size for the training set
Not applicable. The document does not describe a study involving a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a study involving a training set for an algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes a comparison study rather than an independent performance study with new human or animal subjects. The "study" referenced is the process of comparing the Cosman RF Injection Electrodes to legally marketed predicate devices.
- Methodology: The sponsor performed a detailed comparison of the Cosman RF Injection Electrodes' "physical and technical characteristics" and "intended use" to those of predicate devices (Technomed Europe RF Injection Needles (K04237), Cosman Medical TC Electrodes (K050084), and Cosman Medical RF Cannula (K060799)).
- Proof of Acceptance Criteria: The submission asserts that this comparison, along with "testing results" (though specific tests or data are not detailed in the summary), demonstrates that the Cosman RF Injection Electrodes are "substantially equivalent" to the predicates and are "safe and effective for its intended use."
The entire submission is focused on establishing substantial equivalence under the 510(k) pathway, which does not typically require new clinical performance data if substantial equivalence can be demonstrated through technological characteristics and intended use alongside existing predicate devices.
§ 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).