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Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures.
Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

The Ensizor Monopolar Endoscopic Scissors is a single-use ethylene oxide sterile electrosurgical scissors. This device is designed to be used with an electrosurgical monopolar HF generator to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

The device is compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The maximum insertion portion diameter is 2.6 mm, and insertion lengths are 165 cm and 235 cm. The patented Edge Flex™ technology used for the Scissor Blades ("Blades") enhances the cutting performance of this flexible endoscopic scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, as requested in the prompt's outlined structure. Instead, the text is a 510(k) summary for the Ensizor Monopolar Endoscopic Scissors, comparing its technological characteristics and performance data to predicate devices to demonstrate substantial equivalence.

Specifically, the document includes:

• Trade/Device Name: Ensizor® Monopolar Endoscopic Scissors
• Indications for Use: Designed to cut and dissect tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures, and also cauterize tissue.
• Predicate Devices: Ensizor® Endoscopic Scissors (K150939) and the Apollo Endosurgery Endoscopic Scissors (K090583).
• Performance Data: Nonclinical testing was performed to evaluate substantial equivalence. This involved "Product Attribute Testing," "Product Performance Testing," "Sample Cutting" various materials (rubber, polyethylene, different types of sutures), and an "Insulation Test." In all listed tests, both the Ensizor® Monopolar Endoscopic Scissors and the Apollo Endosurgery Endoscopic Monopolar Scissors "All units passed."
• Conclusion: Based on non-clinical performance data, the device is concluded to be as safe, as effective, and performs as well as or better than the predicate devices.

However, the summary does not provide:

1. A table of specific acceptance criteria (e.g., minimum tensile strength, maximum cutting force) and the reported device performance against those predefined criteria. Instead, it states "All units passed" for broad test categories and material cutting.
2. Sample size used for the test set or data provenance beyond "nonclinical testing."
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI assistance (this device is a surgical instrument, not an AI diagnostic tool).
6. Standalone performance (while non-clinical testing was done, the "acceptance criteria" against which it was measured are not detailed).
7. The specific type of ground truth used (e.g., pathology, outcomes data), beyond stating "raw chicken for electrocautery functionality test." The "All units passed" suggests qualitative or pass/fail criteria rather than quantitative ground truth.
8. Sample size for the training set (not applicable as this is not an AI/machine learning device).
9. How the ground truth for the training set was established (not applicable).

Therefore, I cannot fulfill the request using the provided input as the necessary information is not present.

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