Search Results

OKLand Patient Return Electrode Pad is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery.

This device is restricted to use with isolated monopolar electrosurgical generators, not intended for radio frequency ablation.

The device consists of a layer of conductive Copper-Nickel fibbers-coated polyester mesh, encased in a viscoelastic and dielectric polyurethane (PU) gel. These two materials are wrapped and sealed with PU membrane. A (or two) BVR lead (s) is attached outside of the pad, one side of the lead is connected to the conductive mesh, and the other side of the lead is assembled with different kinds of connectors.

This device should be operated by qualified healthcare personnel and is intended to be used for patients with a body weight no less than 0.35 kg (0.81b). , with no upper body weight limit.

The provided text is a 510(k) summary for the OKLand Patient Return Electrode Pad. Within this document, the manufacturer demonstrates the device's substantial equivalence to predicate devices, focusing on technological characteristics and non-clinical performance data.

However, the provided text does not contain information about acceptance criteria or a study that uses a test set, expert readers, or ground truth for evaluating performance metrics like sensitivity, specificity, accuracy, or AUC. Instead, the performance data presented is related to biocompatibility, electrical safety and compatibility, and bench performance tests, which are typical for an electrosurgical accessory.

Specifically, the document states:

• "No clinical data is presented in this submission" (page 5, "Clinical Studies" section). This indicates that the type of study typically involving human-in-the-loop performance, multi-reader multi-case studies, or direct clinical outcomes to establish AI performance metrics is not applicable here.
• The "Bench Performance Test" section mentions that "Performance testing was conducted as recommended by the FDA guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery to support substantial equivalence to the predicate device." It concludes that "The results demonstrated the subject device can perform the intended use as safe and effective as the predicate device." This refers to engineering and lab-based testing, not clinical performance or AI algorithm validation with a test set and ground truth.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device meets those criteria using expert readers and ground truth data, as the nature of this device (an electrosurgical return electrode pad) and the provided 510(k) summary do not involve such a study design. The device approval relies on demonstrating equivalence through non-clinical testing for safety and performance (e.g., electrical safety, biocompatibility, and bench testing).

Ask a specific question about this device