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The HALO® ULTRA Ablation Catheter (used with the HALOEEK Energy Generator, model 1190A-115A) 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 subject device, HALO® ULTRA Ablation Catheter (hereafter referred to as "modified ULTRA") is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. It is used exclusively with HALOFES Energy Generator model 1190A-115A (cleared under K092487).

The provided text describes a 510(k) premarket notification for a medical device, the HALO90 ULTRA Ablation Catheter. It focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and bench testing.

Therefore, the following information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the document, as it is a 510(k) submission, not a study report demonstrating clinical performance against specific acceptance criteria.

The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving a device meets new performance acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.

Here's why the requested information is absent:

• Acceptance Criteria & Reported Performance: The document doesn't define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) that an AI device would typically have. It's comparing the technological characteristics and bench test results of the modified device to the predicate.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts relevant to studies evaluating the clinical performance of a diagnostic or AI-driven device, particularly when assessing its ability to detect or diagnose conditions. This document is for an ablation catheter, which treats conditions, and its filing is based on demonstrating safety and efficacy through equivalence to existing devices, supported by bench testing of physical characteristics.

Specifically addressed, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission is for substantial equivalence based on technological characteristics and bench testing (migration, deflection, catheter distal integrity, detachment). No clinical performance acceptance criteria are mentioned.
2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" refers to bench testing, not a clinical data set. The document lists the specific bench tests performed without providing sample sizes as would be relevant for clinical data, nor does it discuss data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses, often established by expert consensus or pathology. This document describes bench testing where "ground truth" would be engineering specifications or physical measurements, not expert clinical interpretation.
4. Adjudication method for the test set: Not applicable. Adjudication is used to resolve discrepancies in expert interpretation of clinical data. This is a bench test submission.
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. This is for an ablation catheter, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for a physical medical device (catheter), not an algorithm.
7. The type of ground truth used: For the bench testing, the "ground truth" would be the expected physical properties and performance metrics of the catheter as measured against engineering standards. This is not explicitly detailed but is implied by the nature of bench tests like "Migration," "Deflection," "Catheter Distal Integrity," and "Detachment."
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable. See point 8.

Summary of Device and Evidence Presented in the 510(k):

The HALO90 ULTRA Ablation Catheter is a modification of an existing device (original ULTRA). The submission aims to prove substantial equivalence to its predicate devices, not to establish new performance criteria through a de novo clinical study.

Evidence presented for substantial equivalence:

• Technological Characteristics: The modified ULTRA has the "same construction, principles of operation, materials and energy density" as the original ULTRA. The differences are described as "a slight change in the manufacturing process of the endoscope mounting strap, as well as dimensional modification on the pivot mechanism components."
• Bench Testing: The minor differences were evaluated via the following bench tests to ensure no new questions of safety and effectiveness were raised:
  1. Migration
  2. Deflection
  3. Catheter Distal Integrity
  4. Detachment

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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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