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The Aragon Surgical Teleo Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

The indications for use include general surgical procedures (including urologic, vascular, thoracic, and thoracoscopic), and gynecologic surgery procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, bowel resections and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed.

The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Teleo Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

The Aragon Surgical RF Systems consists of two components: the Aragon Surgical Generator and the Aragon Surgical Teleo Instrument. The Aragon Teleo Instrument is provided as sterile and is intended for single use. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws.

The provided text is a 510(k) summary for the Aragon Surgical Teleo Instrument. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, function, and intended use. Therefore, it does not contain the kind of detailed information typically found in a clinical study report that would establish acceptance criteria and prove a device meets them through empirical data.

Here's a breakdown of what can and cannot be extracted from the provided text based on your questions:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided: The document does not define specific acceptance criteria (e.g., performance metrics, thresholds) for the Teleo Instrument, nor does it report detailed performance data from a specific study against such criteria. The basis of clearance is substantial equivalence to a predicate device (K090306), not a demonstration of novel performance against predefined metrics.

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

• Cannot be provided: The document does not describe any specific "test set" in the context of an AI/algorithm evaluation. The "pre-clinical evaluation" mentioned is not detailed enough to extract sample size or data provenance.

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)

• Cannot be provided: This information is not relevant to the type of 510(k) submission presented, which is not for an AI/CADe device requiring expert ground truth for image interpretation.

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

• Cannot be provided: Same as above, not relevant or present.

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

• Cannot be provided: The device is an electrosurgical instrument, not an AI/CADe system. Therefore, MRMC studies are not applicable or mentioned.

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

• Cannot be provided: The device is not an algorithm.

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

• Cannot be provided: No ground truth definition is relevant or provided in this context. The "pre-clinical evaluation" would likely involve engineering tests, animal studies, or cadaver studies, but specifics are not given.

8. The sample size for the training set

• Cannot be provided: Not an AI device, so no training set.

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

• Cannot be provided: Not an AI device.

Summary of available information from the document:

• Device Name: Aragon Surgical RF System Teleo Instrument
• Predicate Device: Aragon Surgical RF System/L2 Instrument (K090306)
• Basis for Clearance: Substantial equivalence to the predicate device.
• Key Statement regarding equivalence: "The technological characteristics of the Aragon Surgical Teleo Instrument are identical to those of the cited predicate electrosurgical device. K090306. This device is equivalent in terms of design, materials, and principal of operation. The modification between the Aragon Surgical Teleo Instrument and the predicate device does not raise new issues regarding safety or effectiveness."
• Conclusion: "Based on the design, materials, function, intended use, and pre-clinical evaluation, the Aragon Surgical Teleo Instrument is substantially equivalent to devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the Aragon Surgical Teleo Instrument raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance."

This 510(k) focuses on the "identity" of the device's technology and intended use with a previously cleared device, asserting that no new safety or effectiveness issues are raised by any modifications. It does not present de novo performance data against specific acceptance criteria.

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