(57 days)
The Single Use Grounding Pad is applied to the patient during electrosurgical procedures to provide a path for the RF current to leave the patient and return to the generator.
The single use grounding pad is a non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode and the patient. The grounding pad is to be used on any patient where full skin contact and a suitable placement site can be obtained. Use of this device for unintended application could lead to an unsafe condition.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LCCS Products Limited Single Use Grounding Pad (K132136):
Device: Single Use Grounding Pad
Premarket Notification Number: K132136
1. Table of Acceptance Criteria and Reported Device Performance
The provided document indicates that the device met the requirements of IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. However, it does not explicitly list specific acceptance criteria values or show them in a table format alongside the reported device performance results. It only states that the device "meets applicable sections of the standards referenced."
Therefore, based only on the provided text, a table with specific criteria and performance values cannot be fully constructed. The acceptance criteria are implicitly defined by the referenced standard, and the reported performance is a general statement of compliance.
| Acceptance Criteria (Defined by Standard) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-2 Edition 5.0 2009-02: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (specific sections not enumerated in the summary) | "Results of performance testing indicate that the grounding pad meets applicable sections of the standards referenced and are safe and effective for their intended use." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for performance testing (e.g., number of grounding pads tested).
The data provenance is not explicitly stated. Given that the submitter is LCCS Products Limited in Hong Kong, and the primary contact is in China, it's likely the testing was conducted in Asia, but this is an inference, not a stated fact. The document does not indicate whether the testing was retrospective or prospective.
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. The testing described appears to be technical performance testing against a recognized electrical safety standard (IEC 60601-2-2), which typically relies on instrumentation and engineering measurements rather than expert human interpretation to establish 'ground truth'.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Technical performance testing against an electrical safety standard typically does not involve an adjudication method in the way medical device clinical studies might. Results are generally objective measurements.
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 provided and is not applicable. The device is a "Single Use Grounding Pad," which is a passive medical accessory for electrosurgery. It is not an AI-powered diagnostic or therapeutic device, nor does it involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not provided and is not applicable. The device is a physical grounding pad, not an algorithm.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" was established by the requirements and methodologies outlined in the IEC 60601-2-2 standard. This standard specifies objective performance and safety criteria for high-frequency surgical equipment and accessories. The testing would have involved engineering measurements to verify compliance with these objective criteria.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a physical medical accessory, not a software or AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 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.