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Aesculap's Bipolar Irrigation Forceps are designed to be used with Aesculap's current Jet Irrigation System (#K971310) and Bipolar Coagulator (#K952524). The Bipolar Irrigation Forceps are intended for use in electrosurgery for coagulation and irrigation of selected tissue.

The bipolar irrigation forceps (GK842R, GK845R, and GK848R) are a "Bayonet" style forceps, similar to Aesculap's currently marketed bipolar irrigation forceps (#K971310). The irrigation channel runs inside the right-hand prong, with an outlet 2.5mm above the tip of the forceps. The new bipolar irrigation forceps are available in lengths ranging from 180mm - 230mm with a tip size of 1.3mm.

The submitted text describes the Bipolar Irrigation Forceps and its 510(k) submission, not a study evaluating a device against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove device performance cannot be extracted from the provided text.

Specifically, the document states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new bipolar irrigation forceps conform to applicable ASTM and ISO standards. The bipolar irrigation forceps do meet the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment)."

This indicates that the device's performance is demonstrated through adherence to recognized industry standards rather than a specific clinical study with predefined acceptance criteria for a novel algorithm or diagnostic performance.

Here's what can be extracted based on the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. The document describes compliance with standards, not a study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The document does not describe a study involving ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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

• No. The document describes an electrosurgical device, not an AI-powered diagnostic tool, and thus no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This is an electrosurgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The device's performance is demonstrated through compliance with engineering standards, not through comparison to a ground truth for diagnostic accuracy.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is a hardware device.

9. How the ground truth for the training set was established

• Not applicable. There is no mention of a training set or ground truth establishment for a training set.

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