(85 days)
The SLT Pneumatic Cutter System is indicated for use in Ear Nose and Throat Surgery primarily sinus endoscopy, and orthopedic procedures primarily arthroscopy. The cutter is intended to achieve the removal of tissue, both soft tissue and bone with the appropriate handpiece. It will also provide suction and irrigation to the operative site.
The SLT Pneumatic Cutter System is intended to cut and remove soft tissue. The primary areas of use are Sinus Endoscopy (ENT) and Arthroscopy (Orthopedic) procedures. The tissue is cut with a disposable cutting blade which has an irrigation and suction port designed into its core. The tissue is automatically suctioned away once cut. The device can also drill bone material and automatically remove the bone dust and fragments through an internal suction port.
The SLT Pneumatic Cutter System is intended to cut and remove soft tissue. The primary areas of use are Sinus Endoscopy (ENT) and Arthroscopy (Orthopedic) procedures. The tissue is cut with a disposable cutting blade which has an irrigation and suction port designed into its core. The tissue is automatically suctioned away once cut. The device can also drill bone material and automatically remove the bone dust and fragments through an internal suction port.
The provided text is a 510(k) summary for the SLT Pneumatic Cutter System. It describes the intended use of the device and states that it has been determined substantially equivalent to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The text explicitly states: "Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used." This indicates that performance data was collected and used for the 510(k submission, but the actual data, acceptance criteria, and study details are not present in this summary.
Therefore, I cannot provide the requested information from the given input.
To answer your request, I would need a section of the document that outlines:
- Specific quantitative or qualitative acceptance criteria (e.g., minimum cutting speed, maximum vibration, minimum suction rate, etc.).
- Results of a study where these criteria were tested.
- Details about the test setup, sample sizes, data provenance, ground truth establishment, or human-in-the-loop studies.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.