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HALO360 + Sizing Balloon model 3441C is indicated for 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 HALO360+ Sizing Balloon model 3441C is used in conjunction with either the HALO360 Energy Generator models 1100C-115B (or 1100C-230B), or HALORLEX Energy Generator model 1190A-115A (or 1190A-230A) for assessing the size of the esophageal lumen, and facilitate the selection of the disposable single-use HALO360+ Coagulation Catheter. The HALO360+ Sizing Balloon model 3441C, like the predicate device HALO360 Sizing Balloon model 3441B is comprised of a sizing balloon, a catheter shaft with markings, and an electrical connector.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the modified device "met the same specifications requirements as the HALO360 Sizing Balloon and HALO360+ Ablation Catheter" for the first four criteria. The fifth criterion is a noted improvement in capability.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The information provided focuses on the device's technical specifications and a comparison to predicate devices, rather than a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The provided text does not contain information about the number of experts used or their qualifications to establish ground truth. As this appears to be a submission based on engineering and performance criteria for substantial equivalence, clinical expert assessment for ground truth is not detailed.

4. Adjudication Method

The provided text does not contain information about any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence based on material and performance specifications, not on comparing human reader performance with or without AI assistance.

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

This question is not applicable. The HALO360+ Sizing Balloon is a medical device, not an AI algorithm. Therefore, a standalone performance study in the context of AI is not relevant. The device itself is designed to be used by a human operator (a physician) to size the esophagus and select a coagulation catheter.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance appears to be established through engineering specifications and testing based on the predicate devices. For example, "sizing accuracy" would be compared against a known, precise measurement standard in a laboratory or simulated environment, rather than a clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

The provided text does not contain information about a training set since this is not an AI/machine learning device. The testing described appears to be for device validation against established specifications.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no mention of a training set for an AI algorithm.

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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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