(192 days)
Medline's Universal Grounding Pads are designed for surgical applications where monopolar electrosurgery is utilized in order to provide a safe return path for the electrosurgical current. Solid Grounding Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Grounding Pads are for use with electrosurgical units (ESU) that have a CQMS (i.e. REM, ARM, NESSY etc.). Medline's Universal Grounding Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this universal style grounding pad. Use of this product for unintended applications could lead to an unsafe condition.
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The provided document is an FDA 510(k) clearance letter for the Medline Universal Grounding Pad. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device.
However, this document DOES NOT contain information about acceptance criteria, device performance testing, study methodologies (like sample sizes, expert ground truth, adjudication methods, MRMC studies), or detailed performance metrics like sensitivity, specificity, or AUC.
The letter is a regulatory document stating that the device is cleared for market based on its similarity to existing devices and compliance with general controls. It does not include the detailed technical study data that would typically be associated with an AI/ML device or a device requiring extensive performance validation against acceptance criteria through a study.
Therefore, I cannot fulfill your request for the specific points listed below based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
- 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: Not applicable (this is not an AI/ML device, nor is a MRMC study mentioned).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is not an AI/ML device).
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/provided.
- The sample size for the training set: Not applicable (this is not an AI/ML device that requires a training set).
- How the ground truth for the training set was established: Not applicable.
This document is for a medical device (a grounding pad for electrosurgery) that gains 510(k) clearance through demonstrating substantial equivalence to a predicate, not through a performance study that would typically be described with the criteria you've outlined. The clearance process for such a device focuses on electrical safety, biocompatibility, and functional equivalence, rather than a clinical performance study with human readers or AI algorithms.
§ 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.