(200 days)
The Diros OWL cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
The Diros OWL Sterile Single Use Disposable 16Ga Cannulae models 466, DHC are identical in construction, materials, energy source and intended use to predicate devices. They are single use disposable devices to be used with the Diros OWL RF Generators.
The 466 series 16Ga cannula consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.
The DHC series 16Ga cannula consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the handle. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.
I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for a medical device (Diros OWL Sterile Single Use R.F. Insulated Cannulae, Models 466 and DHC) applying for substantial equivalence to predicate devices.
While it mentions several types of nonclinical testing performed (biocompatibility, electrical safety/EMC, mechanical, and performance testing), it does not provide:
- Specific acceptance criteria values or thresholds for these tests. It only states that the results demonstrated compliance and matched the performance of predicate devices.
- Detailed study designs or raw data from these tests beyond general categories.
- Information about sample sizes for test sets, data provenance, ground truth establishment, or expert involvement as these types of studies (e.g., studies involving human interpretation or AI performance) are not typically applicable to the substantial equivalence review of this type of medical device (radiofrequency lesion cannulae), which relies heavily on physical and electrical performance rather than diagnostic or interpretative accuracy.
- Any information about multi-reader multi-case (MRMC) studies or standalone algorithm performance, as this is not an AI/software device designed for interpretation.
- Information about training sets, as this is a hardware device undergoing a substantial equivalence review, not an AI model requiring a training phase.
The document focuses on demonstrating that the new device is "substantially equivalent" to already marketed predicate devices by showing similar materials, intended use, technological principle, and performance in standardized engineering and safety tests. The primary performance metric mentioned being different, and expectedly so, is the "larger lesion" created by the larger gauge cannulae, which is then explicitly compared to a predicate device of the same larger gauge.
Therefore, I cannot construct the requested table or provide details about sample sizes, ground truth, or expert adjudication from the provided text.
§ 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).