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The KSEA Paranasal Sinus Shaver, Micro Shaver or Stammberger-Castelnuovo DrillCut-X Shaver in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride, or cut tissue during Head, Neck, ENT and Otoneurological surgical procedures. The KSEA Stammberger-Sachse Intranasal Drill or the INTRA Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting and removal of bone during Head, Neck, ENT and Otoneurological surgical procedures.

The UNIDRIVE ENT System is a motorized, reusable surgical device system that can be used in conjunction with Stammberger Paranasal Sinus Shaver, Micro Shaver, Stammberger-Castelnuovo DrillCut-X Shaver, Stammberger-Sachse Intranasal Drill and INTRA Drill.

This 510(k) premarket notification for the KSEA UNIDRIVE ENT System and Accessories describes the device and its substantial equivalence to predicate devices, but does not contain a study presenting acceptance criteria and device performance results.

The document focuses on demonstrating substantial equivalence based on design features, intended use, and existing predicate device classifications, rather than on specific performance testing with predetermined acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text.

Specifically, the following details are missing:

1. A table of acceptance criteria and the reported device performance: This document provides a "Substantial Equivalence Table" comparing features of the subject device to predicate devices, but it does not list performance metrics or acceptance criteria related to a specific study.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is a surgical shaver/drill, not an AI-powered diagnostic tool, so an MRMC study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Again, not applicable for this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document indicates that "The minor differences in design and dimensions between the subject devices and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices." This suggests that the substantial equivalence argument relies on the similarity of the device to already approved devices rather than new performance studies with specific acceptance criteria.

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