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The unimed Surgical Products unimed Suction-Irrigation Electrode and unimed Sliding Sheath are electrosurgical devices designed for suction/irrigation as well as cutting and coagulating of soft tissue.

unimed Surgical Products intends to market the unimed Suction-Irrigation Electrode with five tip configurations. The tip configurations are the Spatula, J-Hook, L-Hook, Coagulator and Needle. The electrodes are available with a shaft diameter of 5mm and a working length of 28cm or 32 cm. The unimed Sliding Sheath will be marketed in one configuration in 28cm and 32cm lengths. The proximal end is designed to fit a standard monopolar cord.

This document is a Safety and Effectiveness Summary for an Electrosurgical Electrode from 1996. It describes the device, its materials, and claims substantial equivalence to existing devices.

Crucially, this document does not describe acceptance criteria or a study proving the device meets those criteria from an AI/ML or diagnostic performance perspective. Instead, it focuses on the device's physical characteristics, intended use, and substantial equivalence for regulatory approval in a pre-AI era.

Therefore, I cannot extract the requested information from the provided text as it pertains to AI/ML device performance or diagnostic accuracy studies. The concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" in this context would be related to electrical safety, biocompatibility, sterilization efficacy, and functional performance (e.g., suction flow rate, irrigation efficacy, cutting/coagulation effectiveness) for a hardware medical device, not a software algorithm.

To directly address your request given the input, here's an explanation of why the information cannot be provided:

1. Table of acceptance criteria and reported device performance: Not applicable. The document discusses "safety and effectiveness" in a general sense for a medical device (electrosurgical electrode), not specific performance metrics related to diagnostic accuracy or AI output. It does not list specific numerical performance targets or results from a study measuring them.

2. Sample size, data provenance: Not applicable. This refers to data used for AI model training/testing, which is not relevant to this 1996 hardware device submission.

3. Number of experts and qualifications: Not applicable. This refers to experts used for ground truth labeling in AI studies.

4. Adjudication method: Not applicable. This refers to resolving discrepancies in ground truth labeling for AI studies.

5. MRMC comparative effectiveness study: Not applicable. This refers to studies comparing human reader performance with and without AI assistance.

6. Standalone performance: Not applicable. This refers to the performance of an AI algorithm on its own.

7. Type of ground truth: Not applicable. This refers to the reference standard for evaluating AI output.

8. Sample size for training set: Not applicable.

9. How ground truth for training set was established: Not applicable.

In summary, the provided text describes a traditional medical device (an electrosurgical electrode) and its regulatory submission details from 1996, long before the widespread use of AI in medical devices and diagnostic performance studies became a standard requirement for regulatory submissions.

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