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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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The ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids.

The ConMed/Linvatec LightWave" Integrated Electrode Ablators are a modification of the currently marketed 3.2 mm UltrAblator electrode (Linvatec, K030720) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device. One version incorporates handcontrolled buttons to actuate the "cut" and "coag" functions of the electrosurgical generator. Another version is actuated by foot-control to control "cut" and "coag" functions of the electrosurgical generator. The hand-controlled and foot controlled version consists of an electrical insulation coated electrode and ceramic insulator attached to an integrated handle and cord set, allowing attachment to commonly available electrosurgical generators in distribution.

A third version of the ConMedILinvatec LightWave™ Integrated Electrode Ablators incorporates a suction/aspiration feature and is a modification of the currently marketed 3.2 mm Ult Ablator electrode (Linvatec, K993885) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device, and is similar in technology to Heatwave Hand-Controlled Electrode (Conmed, K021299) and the VAPR™ 3.5mm 90° Suction Electrode (Mitek, K002422), which incorporate aspiration or suction. The device is similar to the hand-controlled device and will also have suction capability and attach to commonly available suction equipment. This electrode will be hollow allowing for the removal of irrigating fluids during surgical procedures.

The front switch contained in the hand-controlled devices provide the surgeon with electrosurgical cut (ablate) capability when depressed. The rear button activates electrosurgical coagulating (coag) current.

The provided text is a 510(k) submission for the LightWave™ Integrated Electrode Ablator and LightWave™ Integrated Electrode Suction Ablator. It aims to demonstrate substantial equivalence to previously marketed devices. However, this document does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-driven device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: "ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids."
• Surgical Effect, Function, Materials of Construction, Patient Population, Compliance with Recognized Standards and Published FDA Guidance, and Manufacturing Methods.

The "study" in this context is the 510(k) submission process itself, which asserts that the new device is substantially equivalent to existing predicate devices, implying that its performance is implicitly acceptable because the predicates are already approved.

Therefore, many of the requested details about acceptance criteria for performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission for a Class II electrosurgical device relying on substantial equivalence to establish safety and effectiveness.

Here's a breakdown of what can be gathered from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This document describes a new electrosurgical electrode and relies on demonstrating substantial equivalence to existing devices. It does not present a "test set" in the sense of clinical data points used to evaluate an AI or diagnostic device's performance.

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

• Not Applicable / Not Provided. Ground truth establishment by experts is not a component of this 510(k) filing for an electrosurgical device.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or adjudication method is described.

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 / Not Provided. This is not an AI-driven device or one that involves human readers interpreting results.

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

• Not Applicable / Not Provided. This is an electrosurgical tool, not an algorithm.

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

• Not Applicable / Not Provided. The "ground truth" for this device's acceptance is its substantial equivalence to legally marketed predicate devices, which are presumed safe and effective based on their established clinical use. Testing typically involves bench testing (e.g., power output, insulation integrity, fluid flow for suction), electrical safety, and biocompatibility, not clinical "ground truth" for performance in the same way a diagnostic device would.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable / Not Provided. As per point 8, there is no training set mentioned.

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