Search Results
Found 2 results
510(k) Data Aggregation
(168 days)
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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | The device was evaluated according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Testing included Cytotoxicity, Irritation, Sensitization, and Acute Systemic Toxicity. The joimax® electrosurgical instruments are considered direct tissue contacting for |
Ask a specific question about this device
(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:
-
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.
-
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.
-
Number of Experts, Qualifications: Not applicable.
-
Adjudication Method: Not applicable.
-
MRMC Comparative Effectiveness Study: Not applicable.
-
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.
-
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."
-
Sample Size for Training Set: Not applicable, as this is not an AI model.
-
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.
Ask a specific question about this device
Page 1 of 1