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The HALO360 is indicated for use in the coagulation of bleeding and non-bleeding lesions 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 HALO360 consists of a Generator; a Sizing Catheter; a Coagulation Catheter; and a Catheter Connection Cable. A mains power cord and optional footswitch are also available.

This document does not contain an acceptance criteria table, device performance data, details of a specific study proving the device meets acceptance criteria, or information on AI/ML components.

The submission is a 510(k) summary for the BARRX HALO360 Coagulation System. The manufacturer has claimed substantial equivalence to a predicate device, the Stellartech Coagulation System 2, rather than submitting performance data against specific acceptance criteria.

Here's the relevant information extracted from the document:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The submission states that due to the HALO360 System being "technologically identical" to the cleared Stellartech Coagulation System, "no performance testing was conducted."

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new performance testing was conducted. The submission refers to "Clinical recording:3, as provided to Instructions contained in the Instructions for Use for the HALO360 Coagulation Catheter. That data Instructions for Oscillaccordance with those instructions, the HALO360 uemonstrated that, When wive as the Stellartech Coagulation System for the treatment of Barrett's Esophagus." This seems to refer to instructions for use and not a clinical study to establish performance against acceptance criteria for the new device.

• 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): Not applicable. No new performance testing was conducted requiring ground truth experts.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

• 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: Not applicable. The device is an electrosurgical coagulation system, not an AI/ML-driven diagnostic or assistive device for human readers.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an electrosurgical hardware system.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

• 8. The sample size for the training set: Not applicable.

• 9. How the ground truth for the training set was established: Not applicable.

Based on the provided text, the core of the submission is a claim of substantial equivalence:

"The HALO360 System is technologically identical to the cleared Stellartech Coagulation System 2. Accordingly, no performance testing was conducted."

"The HALO360 is as safe and effective as the Stellartech Coagulation System. The HALO has the same intended use, indications for use, technological characteristics, and principle of operation as the predicate device. The addition of physician's final decision recommending specific power settings for the treatment of Barrett's Esophagus (a cleared indication for use of the predicate device) is based on clinical recording:3 and does not change the device's indications for use. Thus, the HALO360 is substantially equivalent."

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