(61 days)
The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectorny and mastoidotomy. Sinus applications would embody septoplasty and procedures such as the removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR and transspehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy, laryngeal lesion debulking and tonsillectomy. Head and neck procedures would encompass soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal at the cerebellopontine angle.
The modified ESSential Shaver System that is described in this notification has the same technological characteristics, power modality and mode of operation as the originally cleared device.
The provided document is a 510(k) summary for a medical device called the "Modified ESSential Shaver System." This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with detailed performance metrics against specific acceptance criteria. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
Here's a breakdown of why the requested information is absent based on the document's content:
-
Acceptance Criteria and Reported Device Performance: The document does not list specific acceptance criteria (e.g., precision, accuracy, sensitivity, specificity) for the device's performance in surgical procedures. Instead, it states that the modified system "has the same technological characteristics, power modality and mode of operation as the originally cleared device" and that "Differences between the modified ESSential Shaver System and the predicate devices should not affect the safety or effectiveness." This indicates that the established safety and effectiveness of the existing predicate devices are implicitly the "acceptance criteria."
-
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): There is no mention of any new clinical or performance studies being conducted with test sets, training sets, human experts, or ground truth data. The 510(k) process for this device relies on demonstrating equivalence to already cleared devices, not on proving new performance metrics through independent studies.
In summary, the document states that the modified ESSential Shaver System is considered substantially equivalent to existing predicate devices based on its technological characteristics, power modality, mode of operation, and its ability to meet UL and IEC standards. It does not provide details of a study that would define and then prove the device meets specific performance acceptance criteria for new clinical uses.
§ 874.4140 Ear, nose, and throat bur.
(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.