(174 days)
The reprocessed ENT shavers are intended to be used with a reusable hand piece and are designed for use in various ENT, head and neck surgeries and otoneurologic procedures.
Sinus Applications:
- Polypectomy .
- Ethmoidectory/Sphenoethmoidectomy
- Septoplasty
- Antrostomy
- Endoscopic DCR .
- Frontal Sinus Trephination and Irrigation
- Frontal Sinus Drill Out
- Septal Spur Removal
- Trans-Sphenoidal Procedures
Head and Neck Procedures
- Rhinoplasty .
- Lipodebridement in the Maxillary and Mandibular Region .
- Soft Tissue Shaving
- Acoustic Neuroma Removal
Nasopharyngeal and Laryngeal Procedures
- Tonsillectomy .
- Tracheal Procedures .
- Adenoidectomy
- Laryngeal Lesion De-Bulking
- Laryngeal Polypectomy .
Otology Procedures
- Mastoidotomy .
- Mastoidectomy
SterilMed's reprocessed ENT shavers are powered dissectors inserted into a reusable hand piece and designed to be used in the removal of bone and tissue in various ENT, head and neck surgeries, and otoneurologic procedures. These devices were originally manufactured by Gyrus and Medtronic.
Note: Only the shaver is the subject of this submission, the reusable hand piece and any other related equipment are not included in the scope of this submission.
The provided text describes a 510(k) premarket notification for "Reprocessed ENT Shavers" by SterilMed, Inc. It claims substantial equivalence to Gyrus Diego® and Medtronic Xomed XPS® shavers. However, the document primarily focuses on the regulatory submission and does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria in a quantitative, performance-based manner as typically expected for AI/ML device descriptions.
Instead, the submission states: "Representative samples of reprocessed ENT shavers were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced." This indicates that the testing focused on ensuring the reprocessed devices perform similarly to the original devices and meet reprocessing standards.
Given the information in the provided text, I cannot complete the table with specific quantitative acceptance criteria and reported device performance metrics in the way you've outlined for an AI/ML device. The document is a regulatory submission for a reprocessed medical device, not a performance study of an AI/ML diagnostic tool.
The document does not provide details on:
- Specific quantifiable acceptance criteria for performance (e.g., sensitivity, specificity, AUC).
- Numerical reported device performance against those criteria.
- Sample sizes for a "test set" or data provenance in the context of an AI/ML model's evaluation.
- Number of experts used to establish ground truth, their qualifications, or adjudication methods related to diagnostic accuracy.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance (as this is a reprocessed physical device).
- Type of ground truth in an AI/ML context.
- Sample size for a training set or how ground truth for the training set was established.
The "Conclusion" section states: "The reprocessed ENT shavers are substantially equivalent to Gyrus Diego® and Medtronic Xomed XPS® blades. This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction." This is the core "proof" presented for this type of device, focusing on equivalence rather than novel performance metrics.
§ 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.