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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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The OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with a 510k-clearance ESU generator. The device is disposable and supplied sterile with an electrode tip.

The OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for the cutting and coagulation of soft tissue and have a connector attached to a 3M conductive cable and are designed for use with 510K-clearance generator. The connector or pluq fits into the mono-polar side of a 510K-clearance generator. The handpieces (OBS-Db or OBS-Dr) are made of plastic with two buttons or a rocker switch toward the distal part of the pencil in the case of the hand-controlled pencils, while the foot-controlled pencils(OBS-Df) that is activated by a monopolar footswitch connected to the generator (the footswitch is an accessory of the generator). One button or switch is to control the CUT mode of the ESU while the other controls the COAG mode.

This document describes the premarket notification (510(k)) for the OBS Disposable Electrosurgical Pencils. The primary evidence presented is a comparison to legally marketed predicate devices and non-clinical performance and safety testing.

Here's an analysis of the provided text in relation to your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide a table outlining specific performance metrics with PASS/FAIL values as one would expect for a detailed performance study like an MRI co-existence test or a drug-delivery device's accuracy. Instead, the approach is focused on demonstrating substantial equivalence to predicate devices through a battery of general safety and performance tests.

The document lists the following non-clinical tests performed:

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any of the tests conducted. It only states that "Tests were conducted on the OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df." There is no information provided regarding the data provenance (e.g., country of origin of the data, retrospective or prospective). Given the nature of the tests (standardized performance and safety testing), they would likely be conducted in a laboratory setting by the manufacturer JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO.,LTD, which is based in GuangDong, People's Republic of China. The tests are inherently prospective as they are performed specifically for this submission.

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 document. For these types of non-clinical, standardized tests, "ground truth" is typically established by compliance with the specified international standards (e.g., IEC, ISO, ASTM). The "experts" would be the technical staff or engineers performing the tests and comparing results against the standard's requirements, rather than clinical experts establishing a medical "ground truth."

4. Adjudication method for the test set

This is not applicable to the types of non-clinical tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The tests here are objective measurements against engineering and safety standards.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an electrosurgical pencil, which is a surgical tool, not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. Again, this device is a physical electrosurgical tool, and the submission focuses on its physical and electrical safety and performance, not on algorithmic accuracy.

7. The type of ground truth used

The "ground truth" for the tests performed is the compliance with established international and national standards for electrical safety, mechanical performance, biocompatibility, sterilization, and packaging. The successful completion of these tests (i.e., results showing no violation of requirements or safety hazards) serves as proof of acceptable performance for a 510(k) submission.

8. The sample size for the training set

This information is not applicable. This is not an AI/Machine Learning device and therefore does not have a "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

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