(224 days)
SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels.
Devices are monopolar and bipolar electrosurgical electrodes designed for ablation, resection and coagulation of soft tissue. Instruments consist of one or more distal electrodes, an insulated shaft, and a proximal handle with electrical connections to a compatible electrosurgical unit. Monopolar instruments require concurrent use of a compatible return electrode. Models have varying electrode configurations and tip angles. Some models are equipped with suction tubing for continuous cooling of the ablation site and aspiration of fluids/debris during use. Reprocessed electrodes have equivalent technological characteristics as the predicate devices, i.e. device design, dimensions, energy delivery and system compatibility are unchanged during reprocessing. Device materials are identical with the exception of shaft insulation, which may be replaced with a comparable heat shrink material.
The SureTek Medical 510(k) summary provided does not contain the specific type of acceptance criteria and associated study details that would typically be found for a medical imaging AI device. Instead, this document describes the reprocessed electrosurgical electrodes and focuses on demonstrating substantial equivalence to predicate devices for safety and performance in a manufacturing context.
Therefore, I cannot extract the information required concerning an AI device study. The provided text outlines:
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Acceptance Criteria & Device Performance: The document states that "Simulated-use testing of instruments following maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices." This is a broad statement regarding functional equivalence but lacks specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI device. The other listed testing (insulation, cleaning, packaging, sterility, biocompatibility) are related to manufacturing and safety standards, not AI performance.
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Sample Size, Data Provenance: Not applicable in this context as no AI study is described. The "sample" here refers to reprocessed medical devices, not patient data.
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Number of Experts, Qualifications: Not applicable.
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Adjudication Method: Not applicable.
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MRMC Comparative Effectiveness Study: Not applicable.
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Standalone Performance: The closest analogous information is the "Simulated-use testing" which compares the reprocessed devices directly to new, unused devices. This is a standalone comparison for the physical device's function.
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Type of Ground Truth: For the reprocessed electrosurgical electrodes, the "ground truth" seems to be the performance of new, unused devices as the benchmark for "substantial equivalence."
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Sample Size for Training Set: Not applicable, as this is not an AI model.
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How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided SureTek Medical 510(k) summary is for reprocessed electrosurgical electrodes and details performance testing related to manufacturing, safety, and functional equivalence to predicate devices, rather than an AI device's clinical performance study.
§ 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.