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Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.

Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).

Electrosurgical Pads are single-use, non-sterile dispersive electrode with or without a pre-attached cord. This devices are used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The Electrosurgical Pads are designed to be compatible with the return electrode monitoring function of compatible OBS generators.

This document is an FDA 510(k) Clearance Letter for "Electrosurgical Pads." It demonstrates no AI/ML algorithm in its description, and therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI-powered device is not applicable.

The document primarily focuses on demonstrating substantial equivalence of the Electrosurgical Pads to a predicate device and reference devices through:

• Indications for Use comparison: Showing the subject device has the same intended use as the predicate and highly similar indications for use as reference devices.
• Technological Characteristics comparison: Detailing material composition, size, corded/non-corded options, patient weight applicability, and safety/performance standards met.
• Non-clinical performance testing: Listing compliance with relevant IEC and ISO standards for electrical safety, EMC, performance, and biocompatibility.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator. the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).

Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a. GBS-Db 4030c. GBS-Db 4030. GBS-Db 4040c. GBS-Db 4040. GBS-Dm 1030bc. GBS-Db 1031bc. GBS-Dm 1030b. GBS-Db 1031b. GBS-Dm 1130bc. GBS-Db 1131bc. GBS-Dm 1130b. GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1130nc, GBS-Db 1131nc, GBS-Dm 1130n, GBS-Db 1131n, GBS-Dm 2030c, GBS-Db 2031c, GBS-Dm 2030, GBS-Db 2031, GBS-Dm 2130c, GBS-Dm 2130, GBS-Db 2131, GBS-Dm 3030c, GBS-Db 3031c, GBS-Dm 3030, GBS-Db 3031, GBS-Dm 3130, GBS-Db 3131, GBS-Dm 3130c, GBS-Db 3131c. GBS-Db 2131c)

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The text is a formal letter from the FDA regarding a 510(k) premarket notification for "Electrosurgical Pads," confirming substantial equivalence to legally marketed predicate devices. It discusses regulatory matters, such as general controls provisions, additional controls for Class II/III devices, and various regulations (Quality System regulation, MDR, etc.). The indications for use for the electrosurgical pads are also described.

There is no mention of:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

Ask a specific question about this device