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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:

1. 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.

2. 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.

3. Number of Experts, Qualifications: Not applicable.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable.

6. 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.

7. 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."

8. Sample Size for Training Set: Not applicable, as this is not an AI model.

9. 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.

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Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.

The devices that are the subject of this submission are used to remove tissue and control bleeding during surgery. They are made of a variety of materials and come in different shapes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning. refurbishing, testing, packaging, and sterilization. It allows the electrodes to be used several times rather than just once.

The provided text is a 510(k) summary for reprocessed electrosurgical electrodes and an FDA clearance letter. It does not contain information regarding acceptance criteria, study performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies.

The document explicitly states: "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This indicates that a study demonstrating performance against acceptance criteria, as requested in the prompt, was not performed for this submission.

Therefore, I cannot provide the requested information from the given text.

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Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and cauterizing soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.

SterilMed's reprocessed electrosurgical electrodes are a monopolar electrosurgical instruments consisting of a tungsten tip, stainless steel housing, and several layers of insulation.

The provided text is a 510(k) summary for SterilMed's Reprocessed Electrosurgical Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria and performance metrics for a novel AI/software device.

Therefore, many of the requested items (e.g., AI performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies) are not applicable to this submission.

Here's an analysis of the available information:

Device: SterilMed Reprocessed Electrosurgical Electrodes

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the reprocessed device performs comparably to new, equivalent devices and meets safety standards for reuse. The submission emphasizes substantial equivalence rather than numerical performance against specific criteria.

2. Sample size used for the test set and the data provenance

The document indicates "representative samples" were used for bench testing. It does not specify a numerical sample size for these tests. Data provenance (country of origin, retrospective/prospective) is not mentioned, as this is a reprocessed medical device submission, not a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission doesn't involve establishing ground truth from expert interpretations of medical images or data. The "ground truth" here is the functional performance and safety of the reprocessed device, assessed through bench testing and process validation.

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

Not applicable, as this is not a study assessing interpretations of medical data. The evaluation is based on engineering and quality control tests.

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 an electrosurgical electrode, not an AI-powered diagnostic tool.

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

Not applicable, as this is not an algorithm or AI device.

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

The "ground truth" for this device's performance and safety is established through:

• Bench testing: Verifying functional characteristics (e.g., cutting ability).
• Process validation: Confirming the efficacy of cleaning, sterilization, and packaging procedures.
• Comparison to predicate devices: Demonstrating consistency in design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no "training set" for this type of device.

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