(12 days)
The Habib Laparoscopic Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures
The Habib Laparoscopic Hexablate is a bipolar radiofrequency (RF) device that consists of a handle, laparoscopic shaft and introducer and an array of seven parallel electrodes which extend out from the laparoscopic shaft. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Laparoscopic Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Laparoscopic Hexablate is designed for use in laparoscopic surgery and is a single use device.
The provided text describes a medical device, the "Habib Laparoscopic Hexablate," and its 510(k) submission to the FDA. However, the document does not include detailed acceptance criteria or a specific study that proves the device meets those criteria in the context of device performance as one might expect for a robust clinical trial.
Instead, the "Performance Data" section states: "Performance testing was done to ensure that the Habib Laparoscope Hexablate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."
This indicates that the device's performance was evaluated primarily against its predicate devices (Habib Hexablate (K071103) and Habib 4X Laparoscopic (K062935)) to demonstrate substantial equivalence for regulatory approval, rather than through a separate study with predefined acceptance criteria for novel clinical efficacy. The FDA's letter confirms this is a substantial equivalence determination.
Therefore, many of your specific questions cannot be answered from the provided text, as the focus is on regulatory equivalence rather than a clinical effectiveness study with defined performance metrics.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria for performance (e.g., coagulation depth, accuracy, etc.) and corresponding reported device performance values are NOT explicitly stated.
The "Performance Data" section generally states:
- Acceptance Criteria (Implied): The device functions as intended and meets design specifications. It is substantially equivalent to the predicate device, and meets safety and effectiveness criteria.
- Reported Device Performance: "Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."
The "Technological Differences" section provides some comparative details, implying performance equivalence:
- Habib Laparoscopic Hexablate vs. Habib Hexablate (K071103): "Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue. The primary difference is that the Habib Laparoscopic Hexablate is used via a laparoscopic port. The size and shape of the coagulation zone created by each device is similar."
- Habib Laparoscopic Hexablate vs. Habib 4X Laparoscopic (K062935): "Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue during laparoscopic procedures." The main difference is the number and deployment of electrodes.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Device functions as intended. | "Performance testing was done to ensure that the Habib Laparoscope Hexablate functions as intended and meets design specifications." |
| Meets design specifications. | "Performance testing was done to ensure that the Habib Laparoscope Hexablate functions as intended and meets design specifications." |
| Substantially equivalent to predicate device(s). | "Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria." This is further supported by the comparison: "The size and shape of the coagulation zone created by each device [Habib Laparoscopic Hexablate and Habib Hexablate] is similar." and "Both devices [Habib Laparoscopic Hexablate and Habib 4X Laparoscopic] use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue during laparoscopic procedures." |
| Meets safety and effectiveness criteria (as defined by predicate device's performance). | "Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The document refers to "Performance testing" but does not detail the nature of these tests (e.g., in vitro, ex vivo, animal studies) or any human subject data, test set size, or data provenance. Given the nature of a 510(k) for substantial equivalence, clinical trials with large human test sets are often not required if bench and possibly animal testing support the claims relative to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given text. The document doesn't describe a ground truth establishment process by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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. The provided text describes an electrosurgical device, not an AI or imaging diagnostic device. Therefore, an MRMC study involving human readers' improvement with AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical instrument for direct surgical application, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the context of diagnostic or interpretive AI/imaging is not applicable to this device. The performance evaluation would likely involve engineering parameters, tissue coagulation studies (which might use histology/pathology as a "ground truth" for coagulation depth/volume, but this is not specified), and comparison to predicate device performance.
8. The sample size for the training set
This information is not provided and is not applicable as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as this is not a machine learning/AI device.
§ 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.