(212 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functions as Intended (Coagulate tissue in GI tract) | "Performance testing was undertaken to ensure that the Habib EndoHPB functions as intended..." |
| Meets Design Specifications | "...and meets design specifications." |
| Substantially Equivalent to Predicate Device (K072383) | "Sufficient data was obtained to show that the device is substantially equivalent to the predicate device..." |
| Meets Safety and Effectiveness Criteria (General) | "...and meets safety and effectiveness criteria." |
| Bipolar RF energy for tissue coagulation | "Both devices use bipolar RF energy through a number of electrodes to coagulate tissue." |
| Single-use sterile device | "The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device." |
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)
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
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.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).