Search Results

ArtiSeal Vessel Sealing System-ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on veins) up to and including 7 mm. It is indicated for use in general surgery.

The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.

ArtiSeal Vessel Sealing System - ArtiSeal Instruments

The ArtiSeal Vessel Sealing System - ArtiSeal invasive invasive instruments which are used with electrosurgical generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired.

When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies a high frequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation.

During a procedure with this product, the jaw opens, and jaw closes if the grip lever pulled. In addition, the jaw is also bent up, down, left, and right within a range of ±80° or more by moving the grip up, down, left, and tight, and the jaw can also turn 360° when rotating the grip.

ArtiSeal Vessel Sealing System - ArtiSeal Generator

The ArtiSeal Vessel Sealing System - ArtiSeal Generator supplies RF energy to the ArtiSeal Instruments. This energy supply device uses a touchscreen interface and features a unique instrument connecting the ArtiSeal Instrument. By connecting the connector on the ArtiSeal Instrument connection socket, the energy supply device can provide energy to the electrode.

The provided text describes a 510(k) premarket notification for the ArtiSeal Vessel Sealing System and outlines its indications for use and a summary of non-clinical/clinical tests. However, it does not contain detailed information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods in the manner typically presented for AI/ML device studies. The text focuses on establishing substantial equivalence to predicate electrosurgical devices through performance in animal studies rather than rigorous statistical evaluation of an AI component.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can and cannot be answered:

What can be extracted/inferred:

• Study Type: Non-clinical (animal) studies were conducted.
• Purpose of Study: "To evaluate the vessel sealing performance and tissue effects of ArtiSeal Instruments and ArtiSeal Generator. The evaluations included the device's ability to seal vessels of various sizes and types, its effect on tissue damage, as well as the device's safety and efficacy."
• Performance Metrics Mentioned (Qualitative): "complete vessel sealing was achieved without rebleeding as well as problematic macroscopic complications." "evaluation of sealing quality parameters such as tissue adhesion, transparency, desication, and damage to adjacent tissue."
• Ground Truth Type: Inferred to be a combination of direct observation in animal models and evaluation of sealing quality parameters.
• Data Provenance: Conducted in "pigs."

What cannot be extracted from the provided text:

• Table of acceptance criteria and reported device performance: The document only provides qualitative statements about performance, not a table of specific numerical acceptance criteria or results.
• Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document mentions "pigs" but no specific numbers for the sample size, nor details on the country of origin or whether it was retrospective/prospective.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• 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 device is an electrosurgical system, not an AI/ML-driven diagnostic or assistive tool for human readers.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no mention of a standalone algorithm component for diagnostic or interpretive purposes. The "automatic detection" and "safety and diagnostic functions" refer to hardware/firmware functions, not an AI algorithm generating standalone performance metrics.
• The sample size for the training set: Not mentioned (and likely not applicable in the context of an electrosurgical device without a distinct AI training phase for data interpretation).
• How the ground truth for the training set was established: Not mentioned.

Summary based on the provided text:

The provided document describes the clearance of an electrosurgical device, the ArtiSeal Vessel Sealing System. The "study" mentioned is a non-clinical (animal) evaluation to demonstrate the physical performance of the device in sealing and dividing vessels, and its safety. This is distinct from the type of performance study typically conducted for AI/ML-driven diagnostic devices, which would involve detailed metrics of sensitivity, specificity, AUC, and human reader performance with and without AI assistance.

Hypothetical Table (Illustrative, as data is not available in the text):

If this were an AI device, the table would look something like this, but the data below is purely illustrative of what would be present if the document contained AI study details and is NOT from the provided text:

In conclusion, based solely on the provided text, it is not possible to describe the acceptance criteria and study proving the device meets them in the context of an AI/ML device per your detailed request. The device in question is a traditional electrosurgical system, and the provided documentation focuses on its physical performance and safety in animal studies, not statistical validation of an AI algorithm against a specific set of rigorous metrics.

Ask a specific question about this device