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The HALO90 ULTRA Ablation Catheter model 90-9200 (when used with HALOFEN System) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

The HALO® ULTRA Ablation Catheter model 90-9200 is a modification . of the predicate device HALO" Ablation Catheter model 90-9100 currently commercialized in USA. Both catheters have the same constructions, design, principle of operation, materials and energy density. The differences between HALO" ULTRA and its predicate consist in the electrode surface increase and the associated components electrode cap and base. HALO90 ULTRA Ablation Catheter model 90-9200 is used in conjunction with HALOFER Energy Generator There are no changes associated to the HALOFLEX Energy Generator software, hardware and accessories.

The provided text describes a 510(k) premarket notification for the HALO® ULTRA Ablation Catheter Model 90-9200. This is a submission demonstrating substantial equivalence to a predicate device, not a study designed to establish new acceptance criteria or definitively prove performance against specific clinical endpoints. Therefore, much of the requested information (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC studies, ground truth establishment) is not typically part of a 510(k) submission focused on minor modifications to an already cleared device.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific performance acceptance criteria in the typical sense of a clinical study, as it's a modification of a predicate device. Instead, the "acceptance criteria" are implied by the successful completion of a series of bench tests showcasing that the changes did not negatively impact safety and efficacy compared to the predicate. The "reported device performance" is that these tests were passed successfully, indicating equivalence.

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

The document mentions "Bench Tests." These are typically laboratory-based tests and do not involve human subjects. Therefore, the concept of a "test set" in the clinical sense with human subjects, data provenance (country of origin, retrospective/prospective), and sample sizes for clinical data are not applicable or provided here. For bench tests, sample sizes would typically refer to the number of devices or components tested, but this specific detail is not given.

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

Not applicable. Bench tests do not typically involve human expert "ground truth" establishment in the way clinical diagnostic studies do. The "ground truth" for bench tests is defined by engineering specifications and objective measurements.

4. Adjudication Method

Not applicable, as there is no clinical data or expert review process described that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study evaluates human reader performance, usually in diagnostic imaging, and is not relevant to a bench testing submission for an electrosurgical ablation catheter.

6. Standalone Performance Study

Yes, in a way. The "Bench Tests" described represent a standalone evaluation of the modified device's physical and functional characteristics. However, this is not a standalone clinical performance study, but rather a standalone engineering/design verification study. The tests evaluate the device itself without human-in-the-loop performance being the primary focus.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" would be established by:

• Engineering specifications and design requirements: For tests like tensile strength, apposition, and insertion-retraction, the "truth" is whether the device meets pre-defined, measurable specifications.
• Predicate device performance: The ultimate "ground truth" for demonstrating substantial equivalence is that the modified device performs similarly to or better than the legally marketed predicate device on the critical parameters.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context. The manufacturing of the device would follow established quality control processes, but that's different from an algorithm's training data.

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

Not applicable for the same reasons as point 8.

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