Search Results

The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.

The Habib EndoHPB is an 8F RF bipolar catheter that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel. It has an attached cable which connects the device to an RF Generator. RF is applied to the two electrodes at the top of the catheter so that heat is applied to tissue surrounding the catheter.

This document is a 510(k) Pre-market Notification from the FDA regarding the "Habib EndoHPB" device. It claims substantial equivalence to a previously cleared device of the same name (K180165). The only identified difference is "the recommended generator settings for using the Habib EndoHPB with the Erbe VIO 3 electrosurgical unit."

Therefore, the performance data presented is focused on demonstrating that these new settings maintain substantial equivalence, rather than establishing new performance criteria or proving the device meets those criteria from scratch. The document states: "The new settings have been evaluated using the same methods described in the predicate device 510(k), with additional controls, and the resulting performance data show substantial equivalence."

Based on the provided text, there is no detailed information on specific acceptance criteria or a study that rigorously proves the device meets such criteria. The document focuses on demonstrating substantial equivalence to a predicate device, specifically regarding new generator settings. As such, many of the requested details cannot be extracted from this document alone.

Here's an attempt to answer the questions based only on the provided text, with the understanding that most information regarding a standalone study proving acceptance criteria is absent:

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

This document does not provide specific acceptance criteria or reported device performance metrics in a typical table format as would be expected for a de novo device or a device demonstrating new performance claims. The claim is "substantial equivalence" to a predicate device for new generator settings. The "performance data" mentioned refers to showing that these new settings maintain the performance established by the predicate device.

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

Not provided in this document. The document states, "The new settings have been evaluated using the same methods described in the predicate device 510(k), with additional controls, and the resulting performance data show substantial equivalence." Details about the specific test set size, data provenance, or study design (retrospective/prospective) for this evaluation are not included here. We would need to refer to the predicate device's 510(k) (K180165) for such information.

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 provided in this document. This level of detail regarding ground truth establishment would typically be found in a clinical study report, which is not present here.

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

Not provided in this document. Information about adjudication methods is absent.

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. The Habib EndoHPB is an RF catheter for tissue ablation, not an AI-assisted diagnostic or decision-support device that would involve human readers or AI improvement effect sizes.

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

Not applicable. The device is an RF catheter, not an algorithm. The "performance data" mentioned is likely related to the physical performance of the device (e.g., ablation efficacy, tissue damage patterns, temperature profiles) under the new generator settings, not an algorithm's standalone performance.

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

Not provided in this document. Given it's an ablation device, "ground truth" in the context of its performance validation would likely involve histological assessment of ablated tissue, temperature measurements, or other physical/biological markers of ablation effectiveness, rather than typical clinical "ground truth" for diagnostic devices. However, the document does not specify.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models.

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

Not applicable. See point 8.

Ask a specific question about this device