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The Stellartech Coagulation System 2 is indicated for use in the coagulation of bleeding and nonbleeding 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 2 consists of the following components.

• . Stellartech Coagulation Catheter 2
• Stellartech Coagulation Generator 2 .
• . Stellartech Catheter Connection Cable 2
• Optional Stellartech Sheath ●
• Optional Stellartech Footswitch 2. .
• Optional Stellartech Sizing Catheter 2 .
  The proximal end of the Stellartech Coagulation Catheter 2 connects through the Stellartech Catheter Connection Cable 2 to the Stellartech Coagulation Generator 2.

The provided text is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System 2." This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth as would be typical for AI/ML device submissions.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on substantial equivalence rather than explicit performance metrics against pre-defined acceptance criteria for a new clinical study.

2. Sample size used for the test set and the data provenance

This information is not provided. The document does not describe a new clinical study or test set for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As no new test set is described, there's no mention of ground truth establishment by experts.

4. Adjudication method for the test set

This information is not provided.

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

This information is not provided. The Stellartech Coagulation System 2 is an electrosurgical unit, not an AI/ML diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable.

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

This information is not provided. Given the device type, 'standalone algorithm performance' is not relevant.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided. The document refers to prior predicate devices, implying that the "training" for this device would be based on the established clinical use and safety of those equivalent devices, not a computational training set.

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

This information is not provided. Similar to point 8, the concept of "ground truth for a training set" as it applies to AI/ML is not relevant to this traditional medical device submission.

Summary of Device and Regulatory Context (from the provided text):

The Stellartech Coagulation System 2 is an electrosurgical unit and accessories used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific indications like Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, etc.

The device received 510(k) clearance by demonstrating substantial equivalence to a list of previously cleared Stellartech Coagulation System predicate devices (K013139, K023765, K032062, K0324552, K032721, K040240, K041383, K042909). The equivalence was based on its design, principles of operation, materials, and intended use. The 510(k) process in this context did not require a new clinical study with specific performance acceptance criteria or the establishment of ground truth as typically seen for novel diagnostic or AI-driven devices.

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