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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.

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OBS Disposable 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.).

OBS Disposable Electrosurgical Pads are disposable, non-sterile dispersive electrode with or without a pre-attached cord and available in a comprehensive range of shapes and sizes(adult and pediatric). OBS disposable electrosurgical pads, Solid (Model:GBS-Dm) are for use with generators that do not have a Contact Quality Monitoring System(CQMS).OBS disposable electrosurgical pads, Split (Model:GBS-Db) are for use with generators that have a Contact Quality Monitoring System(i.e. REM,ARM,NESSY etc.).

The document provided describes the OBS Disposable Electrosurgical Pads (Models: GBS-Dm and GBS-Db). Based on the provided text, the acceptance criteria and the study proving the device meets them are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for the individual tests (electrical safety, EMC, biocompatibility). However, it indicates the tests were conducted on "the OBS Disposable Electrosurgical Pads, model GBS-Db and GBS-Dm." This suggests that representative samples of each model were used for the testing.

The data provenance is not specified beyond the fact that the tests were conducted by the manufacturer (JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO.,LTD) and reported to the FDA as part of their 510(k) submission. It's typical for such tests to be conducted in a laboratory setting, not necessarily using patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies described are non-clinical (electrical safety, EMC, biocompatibility). These types of tests rely on established scientific methods and instrument readings, not expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical engineering and biological safety tests. Adjudication methods are typically employed in clinical studies where expert consensus is needed to establish ground truth for subjective outcomes.

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. The device is an electrosurgical pad, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical device (an electrosurgical pad), not a software algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:

• Established Standards and Regulations: The tests were conducted in accordance with recognized international standards such as IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, and ISO 10993 series. Compliance with these standards indicates the device meets predefined safety and performance criteria.
• Objective Measurements: Performance is determined by objective measurements obtained from laboratory equipment and validated test methods (e.g., electrical resistance, current leakage, electromagnetic emission levels, cellular responses in cytotoxicity assays).

8. The Sample Size for the Training Set

This information is not applicable. The described tests are for a physical medical device and do not involve "training sets" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

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