(184 days)
The Epix® Electrosurgical Probes are indicated for irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures.
Electrosurgical probes are reusable suction and irrigation devices designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures.
The provided text describes the 510(k) summary for the Epix® Electrosurgical Probes, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device using AI, or complex performance metrics such as sensitivity, specificity, or reader studies.
Therefore, many of the requested categories, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this type of regulatory submission. This submission is for a traditional surgical device, not an AI/ML software device.
Here's a breakdown of the relevant information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standards Met) | Reported Device Performance (Conclusions from Testing) |
|---|---|
| IEC 60601-1 (General requirements for safety) | "Testing demonstrates that the subject Epix Electrosurgical Probes are substantially equivalent to the predicate Modulap Reusable Unipolar Electrosurgical Probes." |
| IEC 60601-1-2 (Electromagnetic compatibility) | Performance was evaluated "side-by-side to evaluate substantial equivalence of performance in a laboratory setting." |
| IEC 60601-2-2 (Particular requirements for high frequency surgical equipment and accessories) | Bench top tests focused "on the functional performance of the suction and irrigation features." |
| ISO 10993 (Biological Evaluation of Medical Devices) | This indicates biological safety was addressed as per the standard. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable for this type of device submission. The performance testing described is benchtop testing comparing the subject device to a predicate device, not a clinical study involving patient data.
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):
This information is not applicable. Ground truth, in the context of clinical expert review, is not relevant for a benchtop performance comparison of physical medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., images), which is not the case here.
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:
This information is not applicable. This is a traditional electrosurgical probe, not an AI/ML-driven device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission is based on the performance of the legally marketed predicate device and compliance with recognized international safety and performance standards for electrosurgical equipment (IEC 60601 series, ISO 10993). The performance of the subject device was compared to the predicate device in a laboratory setting.
8. The sample size for the training set:
This information is not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set" for this 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.