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The Bergen Model 500 Generator is a general purpose solid state generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other.

No, the provided 510(k) summary does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a 510(k) submission for an electrosurgery generator, focusing on demonstrating substantial equivalence to predicate devices based on design and safety standards (e.g., IEC, ANSI) rather than performance metrics derived from clinical studies or specific acceptance criteria for diagnostic accuracy.

Therefore, I cannot provide the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done and the effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This type of 510(k) submission primarily addresses engineering specifications, safety standards, and equivalence to existing devices, not clinical performance studies typically required for devices with diagnostic or AI components.

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