(212 days)
Model EndoTAC™ Monopolar Cautery Probe is designed for hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc.
Not Found
This looks like a 510(k) premarket notification letter, which typically does not contain the detailed study information you're asking for. This document is a regulatory clearance letter from the FDA stating that the device is substantially equivalent to a predicate device. It confirms that the device can be marketed but does not include the specifics of the clinical or technical studies performed to demonstrate that equivalence or to establish acceptance criteria and performance metrics.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on the regulatory approval of the "Oratec Model Endotac Probe" for specific indications for use: "hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc."
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.