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The E Blator is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.

The device is equipped with a patented stainless steel electrode tip encased in a thermal insulator. When used in combination with a compatible electrosurgical generator, the device provides radio frequency (RF) energy for cutting, vaporizing, and coagulating soft tissue. The device enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect with handswitch control, said current then returns back to the electrosurgical unit through the return electrode and connector. This provides the capability for the surgeon to balance tissue dissection and hemostatic effects as needed during a given surgical case. For aspirating models, when coupled with a vacuum system, the surgical field can be cleared of undesirable debris simultaneously by using the aspiration port located at the bottom of the face of the electrode. Removing this debris can facilitate the surgeon's visualization of the surgical field.

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joimax® Bipolar Electrosurgical Instruments
The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.

joimax® Monopolar Electrosurgical Instruments
The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator.
The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The joimax® Electrosurgical Instruments are comprised of a series of instruments to facilitate the delivery of electrical energy from an RF generator to the patient tissue for use in cutting and/or coagulation of tissue.
The joimax® Electrosurgical Instruments use Radio Frequency (RF) energy to induce thermal effects on tissue. The radio frequency is generated by high oscillating electrical current received from a commercially available RF generator.
The joimax® Probes are available in both monopolar and bipolar probe configurations. All joimax® Probes are designed for specific use with joimax® Handpieces. The joimax Handpieces can be used with compatible commercially available surgical generators.

The provided text discusses the joimax® Electrosurgical Instruments and their substantial equivalence to predicate devices, focusing on safety and performance. However, it does not explicitly detail a study with specific acceptance criteria and detailed performance metrics as one might expect for an AI/ML device. The document primarily focuses on demonstrating that the electrosurgical instruments meet general safety and performance standards equivalent to existing legally marketed devices.

Based on the provided text, here's a breakdown of the requested information, noting where specific details are not available for this type of device (e.g., sample sizes for AI/ML models, expert ground truth for image interpretation).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in a quantitative manner for a comparative study against a specific numerical target. Instead, it confirms compliance with various standards and qualitative comparisons to predicate devices. The "acceptance criteria" are implied by adherence to these standards and the demonstration of similar performance to predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For the performance testing, the document states: "Ex-vivo testing was conducted using multiple types of soft animal tissue (kidney, liver and muscle tissue)." It does not specify a numerical sample size for the ex-vivo test set, nor does it provide provenance details like country of origin or whether the data was retrospective or prospective. This is typical for device performance testing involving animal tissue, where the focus is on demonstrating functional equivalence under controlled conditions rather than clinical dataset characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information (number and qualifications of experts for ground truth) is usually relevant for AI/ML devices that interpret data (e.g., images). For electrosurgical instruments, "ground truth" related to tissue effect is typically established through direct observation, standardized pathological assessment, or established physical/chemical measurements by qualified technical personnel or pathologists, rather than expert consensus on interpretation. The document does not specify the number or qualifications of experts involved in assessing the ex-vivo tissue effects, but rather that effect was "assessed."

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

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML studies where human interpretation of complex data (like medical images) is involved. For performance testing of electrosurgical devices, the assessment of tissue effect is often based on objective measurements or standardized observational criteria, and thus explicit adjudication among multiple reviewers isn't usually described in this context. The document does not mention any adjudication method for the performance test set.

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

An MRMC comparative effectiveness study is not mentioned as this device is an electrosurgical instrument, not an AI-assisted diagnostic or interpretive system that human readers would use to improve their performance. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

This question is not applicable. The device is a physical electrosurgical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here. The performance described is of the physical instrument itself.

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

For the performance testing, the "ground truth" for the effect on tissue was likely established through direct observation during ex-vivo testing and possibly subsequent pathological assessment, although pathology is not explicitly named. The document states, "Effect on tissue was assessed and determined to be highly comparable to the predicate device." This "assessment" forms the basis of the functional ground truth for the device's intended use.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device. Therefore, there is no "training set" in the context of machine learning.

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

This question is not applicable as this is not an AI/ML device with a training set.

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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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