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The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S0 and S50) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The VAPR TC Electrode with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

The device description of the VAPR 3.5 mm and 2.3 mm Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) with Integrated Handpiece is as follows. The DePuy Mitek VAPR System is designed for arthroscopic surgical procedures. The System consists of a high frequency Electrosurgical Generator, disposable Electrodes with integrated Handpiece, and a Footswitch. The components are designed and intended to be operated as a single unit. The device description of the VAPR TC Electrode with Integrated Handpiece is as follows. The VAPR Temperature Control Electrode is a soft tissue desiccation device intended for use with the VAPR Systems. Utilization with a VAPR System allows the tip temperature of the electrode to be indicated on the generator display. The device description of the VAPR Suction Electrodes (S00 and S50) is as follows. The VAPR Suction Electrodes are soft tissue ablation and desiccation devices intended for use with the VAPR System. They extend the utility of the system by removing bubbles created during activation from the operating site.

The provided text is a 510(k) summary for DePuy Mitek's VAPR Electrodes. This document is a premarket notification for a medical device that aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing entirely new performance criteria or conducting a comprehensive study to prove novel efficacy or diagnostic performance. Therefore, many of the requested categories for AI/diagnostic device performance studies are not applicable to this type of submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are typically met by demonstrating that the new device performs as safely and effectively as its predicate devices. The performance is "accepted" if it is substantially equivalent to devices already on the market. There aren't specific numerical performance metrics in the way one would see for machine learning models.

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

Not applicable. This is a medical device (electrosurgical electrodes), not a diagnostic or AI device that processes patient data. The "test set" would refer to the physical electrodes themselves and their performance in laboratory or simulated surgical environments, not a dataset of patient information. The document refers to "validation testing (performance testing) for the device modification," but does not specify sample sizes for these tests, which would typically involve testing a specific number of manufactured units according to established test protocols.

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

Not applicable. This is not a diagnostic device. "Ground truth" in this context would relate to the physical performance of the electrodes (e.g., cutting efficacy, coagulation, temperature control), which is measured by engineering and biomechanical tests, not expert interpretation of patient data.

4. Adjudication method for the test set

Not applicable. There is no diagnostic "test set" requiring adjudication by experts.

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 is an electrosurgical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For a device like this, the "ground truth" for performance would be based on:

• Engineering specifications and standards: Performance criteria derived from industry standards (e.g., electrical safety, material biocompatibility, structural integrity, thermal performance) and internal design specifications.
• Biomechanical studies/bench testing: Measurements of tissue cutting, coagulation, and ablation efficacy using ex vivo or in vitro tissue models.
• Predicate device performance: The established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning device.

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

Not applicable. There is no training set for an algorithm.

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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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