(14 days)
The Habib Hexablate 10 is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
The Habib Hexablate 10 is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate 10 has an attached cable which connects the device to an RF Generator. The electrodes are inserted into tissue and the tissue is coagulated using RF power. The Habib Hexablate 10 is designed for use in surgery and is a single use device.
The provided text is a 510(k) premarket notification for the Habib Hexablate 10, an electrosurgical cutting and coagulation device. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive de novo clinical studies with detailed acceptance criteria and standalone performance metrics.
Based on the provided text, the following can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states:
| Criterion | Reported Performance |
|---|---|
| Functionality | Device functions as intended. |
| Design Specifications | Device meets design specifications. |
| Safety and Effectiveness | Sufficient data was obtained to show that the Hexablate 10 meets safety and effectiveness criteria. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set. It mentions "Performance testing" but does not elaborate on the methodology, number of samples, or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) where the focus is often on bench testing and comparison to an existing device rather than a new clinical trial.
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)
No information is provided regarding experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information is provided regarding an adjudication method.
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 MRMC comparative effectiveness study was performed or mentioned, as this device is not an AI-powered diagnostic tool. It is an electrosurgical device for tissue coagulation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done in the sense that the device itself was tested for its ability to function as intended and meet design specifications. However, this is not in the context of an "algorithm only" or "AI" standalone performance, as the device is a physical electrosurgical tool. The "Performance Data" section indicates that the device was evaluated to ensure it "functions as intended and meets design specifications."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth. Given the nature of the device (electrosurgical for tissue coagulation), ground truth would likely be established through objective measurements of coagulation zone size, tissue necrosis, temperature profiles, and potentially histological examination of treated tissue in preclinical models, but these details are not provided in the summary.
8. The sample size for the training set
No information is provided regarding a training set. This is not applicable as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.