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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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The HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

The HALO® Ablation Catheter model 90-9100 operates in conjunction with HALO® Energy Generator model 90-9000. There are no changes to the HALO® Ablation Catheter or HALO® Energy Generator implemented since the devices were cleared by K083737, K062723 and K062441. The product is also identical in principle of operation and energy density to the treatment site with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter. HALO® is substantially equivalent in construction with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter and Microvasive Gold Probe. The product is similar in performance with Olympus Heat Probe.

The provided 510(k) summary for BARRX's HALO System (K093008) indicates that no new performance testing was conducted for this submission.

The submission focuses on expanding the indications for use for the HALO® Ablation Catheter to include Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP) based on the substantial equivalence to previously cleared devices and existing clinical data.

Therefore, the following information cannot be extracted from the provided text as the study described is a review of existing clinical data, not a new performance study with acceptance criteria.

1. A table of acceptance criteria and the reported device performance: Not applicable, as no new 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 for new performance testing. The clinical data supporting the expanded indications was "derived from publications and case studies." The provenance details are not specified.
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, as no new test set was created with expert-established ground truth.
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, as this is not an AI/device assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the expanded indications, the clinical data relied upon was from "publications and case studies" which demonstrated the safety and effectiveness of the device when used for GAVE and RP. This implies that outcomes data from these existing sources served as the basis for substantiating safety and effectiveness for these new indications.
8. The sample size for the training set: Not applicable, as no new training set was explicitly mentioned for algorithmic development in this submission.
9. How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (expanded indications):

The submission argues for the substantial equivalence of the HALO® Ablation Catheter for the treatment of GAVE and RP by referencing:

• Technological Identity and Substantial Equivalence: The HALO® Ablation Catheter model 90-9100 is "technologically identical" to its cleared predicate (K083737, K062723). It also highlights substantial equivalence in principle of operation, energy density, construction, and performance with other predicate devices (HALO360 Ablation Catheter, Stellartech Coagulation Catheter, Microvasive Gold Probe, Olympus Heat Probe).
• Clinical Data Review: Clinical data was provided to FDA "to support the changes in the Instructions for Use associated with the use in the coagulation of bleeding sites for the HALO® Ablation Catheter for the treatment of GAVE and Radiation Proctitis." This data "demonstrated that, when used in accordance with those instructions, the HALO® Ablation Catheter used for the treatment of GAVE and Radiation Proctitis respectively is at least as safe and effective as the cleared HALO® Ablation Catheter for the treatment of bleeding sites in the gastrointestinal tract."
• Basis of Clinical Data: The clinical data supporting the additional indications (GAVE and RP) was "derived from publications and case studies" and facilitated "Physician's Instructions recommending specific treatment settings and selection criteria for the patients (Contraindications, Warnings and Cautions)."
• Similarity of Conditions: GAVE and RP are described as being similar to other already indicated bleeding conditions (esophageal ulcers, Mallory-Weiss tears, etc.) in that they are confined to the mucosal layer, associated with hemorrhage, and treated with coagulative therapy.

In essence, the "study" proving the device meets the acceptance criteria for expanded indications was a retrospective review of existing clinical data from publications and case studies, and an argument for substantial equivalence to previously cleared predicate devices for similar applications. No new pre-market performance study with defined acceptance criteria was conducted.

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