(75 days)
Model Orastat™ Electrothermal Coagulator is designed for hemostasis, and for coagulation of soft tissues during general arthroscopic procedures.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the comprehensive study you've requested regarding a medical device. The document is an FDA 510(k) clearance letter for the "Oratec Interventions Model Orastat Electrothermal Coagulator" from 1997.
It states that the device is "substantially equivalent" to predicate devices, which means it met the regulatory requirements at that time for market clearance based on its similarity to existing devices. However, this letter does not include performance data, study designs, sample sizes, ground truth establishment, or expert qualifications that would typically be part of a detailed study report.
The information I can extract directly from the provided text is:
- Device Name: Model Orastat Electrothermal Coagulator
- Intended Use: For hemostasis, and for coagulation of soft tissues during general arthroscopic procedures.
- Regulatory Clearance: FDA 510(k) clearance (K973158) in 1997 based on substantial equivalence to predicate devices.
Therefore, I cannot fulfill your request for the specific details outlined in your points 1-9 using only the provided text, as this information is not present. This document is a regulatory approval letter, not a detailed scientific study report.
§ 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.