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The Radionics DGP-HP Single Use Ground Pad is to be used with the Radionics Cooltip™ RF System.

The Radionics Disposable Grounding Pad, DGP-HP, is a dispersive electrode that self adheres to the patients skin. The pad consists of an electrode element made up of a rubberized foam backing, a conducting plate, and a conductive gel. The electrode element is joined to a cable and standard connector that interfaces with an RF generator.

This document describes the Radionics Single Use Grounding Pad (DGP-HP). The submission is a 510(k) summary, which indicates that the manufacturer is demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical trial data for new device approval. As such, the information typically requested in your prompt (e.g., detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is generally not included in a 510(k) summary for this type of device.

510(k) submissions for accessories like grounding pads primarily focus on demonstrating that the new device performs as intended and is as safe and effective as a legally marketed predicate device. This is often achieved through engineering testing, biocompatibility testing, electrical safety testing, and performance testing against recognized standards rather than extensive clinical efficacy studies with human subjects.

Here's a breakdown of the available information in relation to your request, with an emphasis on what is not present as per the nature of the document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document states that the grounding pad is designed to conform to "applicable sections of ANSI/AAMI HF18-1993, IEC 60601-2-2, 1998, and ISO 10993-1." However, the specific acceptance criteria (e.g., maximum impedance allowed, specific temperature rise limits, adhesion strength, biocompatibility results) from these standards, and the reported device performance against them, are not detailed in this 510(k) summary. These details would typically be in a more comprehensive technical report submitted to the FDA, but not in the public 510(k) summary.
• Reported Device Performance: No specific quantitative performance metrics are provided in this summary. The summary only generally states that the device is a "dispersive electrode that self adheres to the patient's skin" and "interfaces with an RF generator."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided in this summary. For this type of device (electrosurgical grounding pad), a "test set" in the context of clinical performance data is not typically relevant in a 510(k) submission. Testing usually involves laboratory-based engineering and performance testing on physical units of the device, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided in this summary. "Ground truth" established by human experts is relevant for diagnostic or AI-driven devices assessing images or patient data. This device is an accessory that performs a physical function.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided in this summary. Adjudication methods are used to resolve disagreements among experts interpreting data, which is not relevant for this device.

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, this was not done. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of data, often with AI assistance. This device is a medical accessory, not a diagnostic tool with AI.

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

• No, this was not done. Standalone algorithm performance is relevant for AI/software devices. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided in this summary. The "truth" for this device would be its adherence to engineering and safety standards, and its physical performance (e.g., maintaining safe temperature, proper electrical dispersion), rather than a clinical ground truth.

8. The sample size for the training set

• Not applicable/Not provided in this summary. Training sets are for AI/machine learning models.

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

• Not applicable/Not provided in this summary.

Summary of Device Acceptance and Study as described in the provided text (within the context of a 510(k) for an accessory):

The acceptance criteria for the Radionics Single Use Grounding Pad (DGP-HP) are based on the device conforming to applicable sections of recognized international and national standards:

• ANSI/AAMI HF18-1993
• IEC 60601-2-2, 1998
• ISO 10993-1

The "study" demonstrating the device meets these criteria is an internal performance and safety evaluation, the details of which are not public in this summary. Instead, the 510(k) process relies on the assertion of substantial equivalence to predicate devices (Radionics RFG-DGP Disposable Grounding Pad K923647 and Nikopad Electrosurgical Grounding Pad Model 4777M K000079) which presumably met similar standards and demonstrated safe and effective use. The FDA's clearance (K030697) indicates that they reviewed the manufacturer's submission (which would contain detailed test reports) and agreed that the new device is substantially equivalent to the predicates.

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