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The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Generator ●
• Stellartech Coagulation Probe Connection Module .
• Stellartech Coagulation Probe .
• Optional Stellartech Footswitch. ●
  The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.

The provided text is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish acceptance criteria and prove a device meets them through a clinical study in the way a new, high-risk device might.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation of the provided document's purpose:

The document focuses on demonstrating substantial equivalence to existing predicate devices (e.g., Stellartech Radiofrequency Generator, ArthroCare Electrosurgery System Generator, etc.). This means the manufacturer is asserting that their new device is as safe and effective as devices already on the market, rather than proving a novel claim against specific performance criteria derived from a new clinical study. The FDA's review (as indicated in the letter from Celia M. Witten, Ph.D., M.D.) confirms this substantial equivalence based on design, principles of operation, materials, and intended use.

The document lists:

• Trade Name: Stellartech Coagulation System
• Common Name: Electrosurgical Unit and Accessories
• Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories (21 CFR 878.4400)
• Indicated Use: Coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific conditions like Esophageal Ulcers, Mallory-Weiss tears, etc.
• Predicate Devices: A list of previously cleared electrosurgical devices.
• Device Description: Components of the Stellartech Coagulation System.
• Conclusion: The device is substantially equivalent to currently marketed devices.

In summary, this 510(k) submission is not a clinical study report designed to show an AI/device meets specific performance metrics against an established ground truth with quantified acceptance criteria. It's a regulatory document demonstrating that a new device is "like" an old, already-approved device.

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