(75 days)
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
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Electrical Safety | All testing items passed the specified standards (IEC 60601-1, IEC 60601-2-2), demonstrating compliance with safety and performance requirements. |
| Electromagnetic Compatibility (EMC) | Testing items for Emission and Immunity, Harmonic Current Emissions, Voltage changes, Voltage Fluctuations, and Flicker passed the specified standard (IEC 60601-1-2), demonstrating compliance with safety and performance requirements. |
| Biocompatibility | Testing items for Delayed Hypersensitivity, Skin Irritation, and In Vitro Cytotoxicity passed the specified standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12). The test results showed no sensitization, no skin irritation, and no cytotoxicity for both aged and unaged samples, demonstrating compliance with safety and performance requirements. |
| Substantial Equivalence | The devices were found to be substantially equivalent to legally marketed predicate devices, with similar intended use, appearance, essential components, materials, and performance specifications. Differences in color and shape were determined not to affect safety and effectiveness. |
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.
§ 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.