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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.

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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, a 510(k) Pre-market Notification for the Habib EndoHPB, details the device's substantial equivalence to a predicate device, focusing on its expanded indications for use. It outlines the performance and clinical data submitted to support these expanded uses.

Acceptance Criteria and Reported Device Performance

The provided document does not contain a typical "acceptance criteria" table with specific quantitative thresholds for device performance (e.g., sensitivity, specificity, accuracy) akin to what might be seen for diagnostic AI devices. Instead, the "acceptance criteria" for this device, which is a therapeutic radiofrequency (RF) catheter, are implicitly demonstrated through:

• Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This involves showing that the device is as safe and effective as the predicate.
• Performance Data: Non-clinical (bench) testing to confirm fundamental device properties, such as shelf-life and compatibility with new generators.
• Clinical Data: Studies to demonstrate the safety and effectiveness of the device for its expanded indications for use, particularly for the ablation of tissue in pancreatic and and biliary tracts, and for clearing occluded stents.

Therefore, the table below summarizes the differences and the justification for substantial equivalence, which serves as the "acceptance criteria" framework for this type of device submission.

Justification: "Multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate. All the clinical studies provided within this submission have been performed using the subject device and clearly support the new intended use." The subject device has the same fundamental technology, design attributes, materials, and functions as the predicate. |
| Extended Shelf-Life (Device functionality and safety maintained over 3 years) | Reported Performance: New claimed shelf-life of 3 years.

Justification: "The results obtained support the claimed 3-year shelf-life." This implies non-clinical testing was performed (e.g., accelerated aging, real-time aging studies) to confirm material degradation, sterility, and functional performance over the extended period. |
| Compatibility with New Generators (Safe and effective operation when connected to additional RF generators) | Reported Performance: Compatibility with additional generators: Olympus ESG-100, Genii GI 4000, ERBE VIO 200, ERBATOM ICC 200, 300, 350. (The predicate was compatible with RITA Medical Systems 1500, RITA Medical Systems 1500X, Radionics Cosman Coagulator CC-1).

Justification: "The results obtained support... the compatibility with new generators." This implies testing was performed to ensure that the device performs as intended and safely (e.g., no overheating, appropriate power delivery, no electrical hazards) when used with these new generators, meeting relevant electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18). |
| Fundamental Technological Equivalence (No significant changes in design, material, energy source, or manufacturing process that raise new questions of safety or effectiveness) | Reported Performance: "Compared to the predicate device, there has been no change or modification in design, material, energy source or manufacturing process in the subject device." The device remains an 8F RF bipolar catheter with 2 ring electrodes, stainless steel active electrode material, delivered endoscopically, single-use, and ETO sterilized. The core mechanism of action (bipolar RF energy ablation) is unchanged.

Justification: The 510(k) submission states that "the evidence collected in the table above clearly demonstrate that, except for insignificant differences, the subject device, the Habib EndoHPB, is identical to the previously cleared Habib EndoHPB (K083292) in terms of fundamental technology, design attributes, materials, features, functions, and performance." |
| Electrical Safety and Electromagnetic Compatibility (EMC) (Compliance with recognized international standards for medical electrical equipment) | Reported Performance: "Electromagnetic compatibility and electrical safety testing have been performed on the Habib EndoHPB to validate that it meets the requirements of the latest Recognized Consensus Standards."

Justification: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18. |

Study Proving Device Meets Acceptance Criteria

The document states that "multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate" for its new intended use. However, the details of these specific studies (e.g., design, endpoints, results) are not provided within this 510(k) summary. This summary only states that such studies were submitted and supported the new intended use.

Based on the provided text, the following information regarding the study cannot be definitively extracted:

1. Sample sizes used for the test set and the data provenance: Not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is a therapeutic device, not a diagnostic AI device requiring expert consensus for ground truth on images. The "ground truth" would relate to clinical outcomes (e.g., successful ablation, stent clearance, complication rates).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/specified.
4. 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 is a therapeutic device, not an AI-assisted diagnostic imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a therapeutic device that works with a human operator.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While not explicitly stated, for a therapeutic device performance, the ground truth for clinical studies would typically involve outcomes data such as:
   • Successful ablation (e.g., histological confirmation if biopsies are taken, imaging follow-up)
   • Successful biliary drainage/decompression
   • Successful stent clearance
   • Complication rates (e.g., perforation, bleeding, pancreatitis)
   • Adverse event rates
   • Patient survival/quality of life (if long-term follow-up was part of the study).
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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The Habib EndoHPB is intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.

The Habib EndoHPB is a bipolar radiofrequency (RF) device that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib EndoHPB has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device.

The provided K083292 submission for the Habib EndoHPB does not include detailed acceptance criteria or a specific study that proves the device meets such criteria in the way typically associated with AI/ML device performance evaluation.

Instead, this submission is for a conventional electrosurgical unit and relies on a demonstration of substantial equivalence to a predicate device (Habib Endoblate catheter, K072383).

Here's an analysis based on the provided text, highlighting what is and isn't present regarding acceptance criteria and performance studies:

Acceptance Criteria and Reported Device Performance

The submission focuses on the device functioning "as intended" and meeting "design specifications" to establish substantial equivalence, rather than defining specific, quantifiable acceptance criteria like sensitivity, specificity, or AUC which are common for AI/ML devices.

No specific quantitative metrics or thresholds (e.g., specific coagulation depth, lesion size uniformity, power output ranges) are explicitly stated as acceptance criteria in the provided text. The evaluation is qualitative and comparative against the predicate.

Study Information (as applicable to this type of device submission)

1. Sample size used for the test set and the data provenance:

   • Not explicitly stated. The submission mentions "Performance testing was undertaken," but does not detail the nature of this testing (e.g., in vitro, ex vivo, animal studies, human trials), the number of samples/cases tested, or their origin. For a device like this, testing might involve bench testing on tissue phantoms or ex vivo tissue samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not stated. Given that this is an electrosurgical device for tissue coagulation, the "ground truth" would likely be objectively measurable physical effects (e.g., tissue temperature, lesion depth, lack of charring, power delivery metrics) rather than subjective expert interpretation of images or clinical findings. The submission does not specify the involvement of experts in establishing ground truth for performance testing.

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

   • Not applicable/None stated. Adjudication methods are typically used for establishing ground truth in AI/ML performance studies where human interpretation is involved. For this device, performance is likely assessed through objective measurements against design specifications and physical properties.

4. 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, an MRMC study was not done. This is not an AI/ML device, and therefore this type of study is not relevant.

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

   • Not applicable. This is not an AI/ML algorithm. The performance of the device ("algorithm only") would be its physical output and effect on tissue, which was assessed through "performance testing." However, the term "standalone" in this context is typically reserved for AI/ML algorithms.

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

   • Implied objective measurements against design specifications and functional intent. For an electrosurgical device, ground truth would relate to the physical effects of energy delivery on tissue (e.g., measurable coagulation, temperature profiles, impedance changes) rather than diagnostic interpretations. The submission doesn't explicitly state the methodology for establishing "ground truth," but it would involve standard engineering and biological testing.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device that requires a training set.

In summary: The K083292 submission for the Habib EndoHPB demonstrates safety and effectiveness through substantial equivalence to a predicate device, supported by general "performance testing" to ensure it functions as intended and meets design specifications. It does not provide the detailed, quantitative acceptance criteria and study methodologies, particularly those related to a test set and ground truth establishment, that would be expected for an AI/ML-driven medical device.

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