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The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing. coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures. Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.

ISOCOOL Bipolar Forceps consist of an insulated, reusable handle in irrigating and non-irrigating styles and sterile, disposable tips.

The provided text does not contain information about specific acceptance criteria or a detailed study proving that the "CODMAN ISOCOOL Bipolar Forceps" meets such criteria. Instead, it describes a 510(k) premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices.

The document focuses on the regulatory process for device clearance, stating that "Substantial equivalence for this device was based upon comparison to predicate device characteristics and performance testing. All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use." However, it does not provide the specifics of these "performance testing" results beyond this general statement.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document states that performance testing was conducted to demonstrate substantial equivalence, but it does not detail specific acceptance criteria (e.g., specific thresholds for coagulation efficiency, temperature profiles, or mechanical strength) or report quantitative performance data for the device against such criteria.

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

• Cannot be provided. The document does not mention the sample size of any test sets used or the provenance of the 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/Cannot be provided. This type of information is typically related to diagnostic or image-based devices where expert interpretation establishes a "ground truth." For a surgical instrument like bipolar forceps, the "ground truth" would likely be operational performance metrics and safety, which are generally evaluated through engineering tests, benchtop studies, and potentially animal or cadaver studies, rather than expert-established diagnostic ground truth. There is no mention of experts establishing a ground truth in this context.

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

• Not applicable/Cannot be provided. Adjudication methods are usually relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies need to be resolved. This is not applicable to the type of device and testing implied here.

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 applicable. This type of study (MRMC, AI assistance) is for diagnostic devices or AI-driven systems, not for a standalone surgical instrument like bipolar forceps.

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

• Not applicable. This refers to AI algorithms. The device is a surgical instrument, not an algorithm.

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

• Cannot be provided definitively. As mentioned in point 3, the concept of "ground truth" in the diagnostic sense is not explicitly applicable here. For a surgical instrument, "ground truth" would likely be defined by successful functional performance (e.g., effective coagulation, mechanical integrity, safety) as measured by engineering specifications and relevant test standards. The document only states "performance testing" was done without specifying the nature of that testing or how success was defined.

8. The sample size for the training set

• Not applicable. There is no indication of a "training set" as this device is not a machine learning model.

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

• Not applicable. As above, no training set is mentioned or implied.

In summary, the provided document is a 510(k) summary for regulatory clearance, not a detailed technical report of device performance testing. It asserts that performance testing was done to demonstrate substantial equivalence, but it does not disclose the specifics of that testing.

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