Search Results
Found 1 results
510(k) Data Aggregation
(30 days)
The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.
This document describes a 510(k) submission for the Nikomed Electrosurgical Grounding Pad. However, the provided text does not contain detailed acceptance criteria or a study design with specific performance metrics (like sensitivity, specificity, AUC, etc.) that are typically associated with AI/ML device evaluations.
The submission is for a medical device that appears to be a passive electrosurgical grounding pad, not an AI/ML-driven diagnostic or therapeutic device. The "SUMMARY of TESTING" section only mentions biocompatibility testing.
Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this particular document.
Here's an attempt to answer the questions based on the provided text, highlighting where information is missing or not applicable:
Description of Acceptance Criteria and Study for Nikomed Electrosurgical Grounding Pad
This 510(k) submission is for a traditional medical device (an electrosurgical grounding pad), not an AI/ML diagnostic or therapeutic device. Consequently, the "acceptance criteria" and "study" described herein are primarily focused on safety, fundamental device function, and substantial equivalence to a predicate device, rather than performance metrics typically associated with AI/ML.
1. A table of acceptance criteria and the reported device performance
Given the nature of the device (an electrosurgical grounding pad), the "acceptance criteria" appear to be related to safety and material compatibility rather than diagnostic performance.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility (e.g., irritation, sensitization, cytotoxicity based on ISO 10993-1 for acute <24 hr intact skin contact) | "The materials passed all screens." | This confirms the device materials are safe for their intended contact with skin. |
| Electrical Conductivity (implied for effective grounding) | Not explicitly stated in the summary, but implied by the device's function as an electrosurgical grounding pad and substantial equivalence to K853291. | |
| Adhesive Strength (implied for secure attachment) | Not explicitly stated in the summary, but implied by the device's function and substantial equivalence. | |
| Mechanical Integrity (e.g., cable durability, pad flexibility) | Not explicitly stated in the summary, but implied by the device's function and substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document states: "Biocompatibility testing consistent with the ISO 10993-1, recommended material evaluations for acute (less than 24-hour) intact skin contacting devices. The materials passed all screens."
- Sample Size: Not explicitly stated. For biocompatibility testing, this would typically refer to the number of samples of the device materials tested using various in-vitro and/or in-vivo models (e.g., cell cultures, animal models for irritation/sensitization). The specific numbers are not provided in this summary.
- Data Provenance: Not specified, but generally, biocompatibility testing is conducted in accordance with international standards (ISO 10993-1) by specialized laboratories. The original source animals or human participants (if any patch testing were performed) are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For biocompatibility testing, ground truth is established by standardized laboratory methods and readings, not expert consensus on medical images or patient diagnoses. The results are interpreted by toxicologists or material scientists, but it's not "experts establishing ground truth" in the diagnostic sense.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies (e.g., reading medical images). This submission is for biocompatibility testing, where results are typically objective and determined by laboratory protocols.
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
Not applicable. This device is a passive electrosurgical grounding pad, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used
The ground truth for the reported testing is based on standardized laboratory test results for biocompatibility, as defined by ISO 10993-1. For example, cytotoxicity tests measure cell viability, irritation tests evaluate inflammatory responses, and sensitization tests assess allergic reactions against established benchmarks and controls.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set exists for this type of device.
Ask a specific question about this device
Page 1 of 1