(294 days)
The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure
The Single Use Micro Electrodes are the monopolar active device which consist of a conductive electrode tip, an insulated shaft and a conductive post.
The conductive electrode tip configuration includes micro needles, scalpel blade, ball, broadbent, wire, triangle loop, diamond loop and round loop.
The conductive electrode tip is the conductive portion of the electrode which delivers high frequency current onto a soft tissue for cutting and coagulation during an electro-surgery
The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material included Polyolefin and /or PTFE Shrink Wrap, overmold, in order to prevent accidental conduction of the electrosurgical current from this point to the patient.
The conductive post is used to pluq the electrode into the nozzle of an electrosurgical pencil from which it receives the electrical current. The diameter of the conductive post is available in 2.36mm and 1.6mm.
This device is used in conjunction with electrosurgical pencil, a compatible monopolar electrosurgical generator and patient grounding pad during electrosurgical procedure.
Based on the provided text, the device in question is a "Single Use Micro Electrode" used for electrosurgical cutting and coagulation. However, the document is a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices.
This document describes a device that is compared to predicate devices based on technological characteristics and performance testing data to establish substantial equivalence. It does NOT describe a study evaluating the performance of an AI/ML powered device, nor does it lay out explicit "acceptance criteria" in the sense of performance metrics typically used for AI/ML models (e.g., sensitivity, specificity, AUC).
Therefore, I cannot extract the information required by your prompt, as the prompt's questions are geared towards the evaluation of an AI-powered diagnostic or similar system, which is not what this document pertains to.
The document discusses:
- Performance Testing Data: "Operation Tests include comparative testing was performed on porcine tissue: kidney, liver, and muscle for both Cut mode and Coagulation mode. It demonstrates that the thermal effect and tissue stickiness on the tip of electrode are no significant difference between proposed device and predicate device."
- Safety and Biocompatibility testing data: Compliance with electrical safety standards (IEC60601-1, IEC60601-2-2) and biological tests (Intracutaneous Reactivity, In vitro Cytotoxicity, Skin sensitization) showing "No biological effect resulted."
These are typical tests for electrosurgical devices to prove safety and efficacy, not AI/ML model performance.
To directly answer your request based on the absence of the information in the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document discusses comparative testing results, noting "no significant difference" in thermal effect and tissue stickiness compared to predicate devices, and that safety tests showed "no biological effect." There are no quantitative acceptance criteria (like sensitivity/specificity targets) for an AI/ML model.
- Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for the "operation tests." It mentions "porcine tissue: kidney, liver, and muscle" but not the number of samples or animals.
- Data Provenance: Porcine tissue (animal study). No country of origin is specified for the tissue or the tests themselves, only that the company is located in Hong Kong, China.
- Retrospective or Prospective: The "operation tests" would be prospective as they were performed specifically for this submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML study requiring expert ground truth for imaging or diagnostic interpretation. The evaluation seems to be based on physical properties (thermal effect, tissue stickiness) and biological reactions.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Not an AI/ML study.
- 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-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance claims appears to be based on direct measurable effects (thermal effect, tissue stickiness) and standard biological safety assays.
- The sample size for the training set: Not applicable. There is no AI/ML model involved, hence no training set.
- How the ground truth for the training set was established: Not applicable. No training set.
§ 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.