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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 HALO® Ablation Catheter (used with the HALOFER 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 HALO® (subject device) is a single-use bipolar device that delivers radiofrequency energy to the treatment tissue within the gastrointestinal tract. It is used solely with the HALOFES Energy Generator (model 1190A-115A), which provides the radiofrequency energy.

The HALO60 Ablation Catheter is a modification of the HALO90 Ablation Catheter, primarily involving a reduction in the copper electrode surface area. The submission is a Special 510(k) as the modification does not change the intended use or alter the fundamental scientific technology.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the HALO60 Ablation Catheter. Instead, it focuses on demonstrating substantial equivalence to a predicate device (HALO90 Ablation Catheter) based on the absence of new questions of safety or effectiveness.

The "performance" is implicitly demonstrated through the modifications and the conclusion of substantial equivalence.

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

The document does not describe a specific clinical "test set" with a sample size in the traditional sense of evaluating a new device's performance against clinical endpoints. The submission relies on design verification activities and a comparison to the predicate device's established safety and effectiveness.

• Sample Size for Test Set: Not applicable as a clinical test set for performance evaluation is not described.
• Data Provenance: Not applicable as a clinical test set for performance evaluation is not described. The document pertains to regulatory submission data.

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

This information is not applicable to this submission. The document focuses on engineering and design verification rather than clinical outcomes requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to this submission as a clinical test set requiring adjudication is not described.

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

This information is not applicable. The HALO60 Ablation Catheter is a medical device for radiofrequency energy delivery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable. The HALO60 Ablation Catheter is a physical medical device, not an algorithm, and operates with human intervention during its use.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through design verification activities against design input requirements, and based on the established safety and effectiveness of the predicate device (HALO90). The document highlights:

• Design Input Requirements: The modified device's design outputs were verified to meet these.
• Predicate Device's Established Performance: The HALO90's prior clearances (K093008, K083737, K062723) serve as the basis for demonstrating substantial equivalence.
• Failure Modes, Effects, and Criticality Analysis (FMECA): Used to analyze risks, implying that safety standards and risk mitigation served as a form of "ground truth" for design decisions.

8. The Sample Size for the Training Set

This information is not applicable. The HALO60 Ablation Catheter is a physical medical device; there is no "training set" of data in the context of machine learning or AI.

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

This information is not applicable for the reasons stated in point 8.

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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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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 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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The HALOFLEX Energy Generator is indicated for use for the coagulation of soft tissue.

The HALOFLEX Energy Generator 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, and Angiodysplasia.

The HALOFLEX Energy Generator is a modification to the HALO360 Energy Generator and HALO® Energy Generators that have already been cleared by the Food and Drug Administration ("FDA" or the "Agency") for use in coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus (K051168 and K060169, K062441 respectively). The Generator has the same intended use and fundamental scientific technology as the cleared HALO360 and HALO90 Energy Generators. In addition, the intended use was expanded to include "coagulation of soft tissue", for this indication for use the predicate device is the RF 3000 Radiofrequency Generator (K000241).

The design changes between the HALO360 and HALO® Energy Generators and the HALOFLEX Energy Generator do not affect the clinical parameters employed in the energy delivery or the safety mechanisms that control those parameters.

The HALOFLEX Energy Generator has a limited number of design changes compared to the predicate devices. These changes are minor and do not raise no questions or effectiveness. Further, bench testing demonstrated comparable performance and safety. These modifications were as follows:

• Add to the indications for use the "coagulation of soft tissue", to reflect the . general nature of the device.
• Modification of the CPU board, for increased memory .
• Consolidation of the Pressure Monitoring Board and RF MUX Board in the Hand Piece Interface Board
• Integration on the HALO360 and HALO90 Energy Generators on the same . hardware platform as HALO360 Energy Generator
• . Update the software codes to reflect the specific performance characteristics for each Energy Generator.
• Optimization of components for reliability, and/or obsolescence

Here's an analysis of the provided text regarding the HALOFLEX Energy Generator, addressing the specific points requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the HALOFLEX Energy Generator does not explicitly define quantitative acceptance criteria or provide specific numerical device performance metrics in the way one might expect for a diagnostic or AI-driven device.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means the acceptance criteria are implicitly that the HALOFLEX Energy Generator performs at least as safely and effectively as the predicate devices.

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

The document does not specify a "test set" in the context of a clinical study with a defined sample size. The performance data mentioned refers to "bench testing" and compliance with standards rather than a clinical trial where patients or specific datasets are evaluated.

Therefore:

• Sample size for the test set: Not applicable/Not provided. The submission focuses on substantial equivalence through design and bench testing, not a clinical test set.
• Data provenance: Not explicitly stated as retrospective or prospective clinical data. The "bench testing" implies laboratory-based data, not patient data from a specific country of origin.

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

This information is not applicable/not provided. The submission does not describe a process of establishing ground truth by medical experts for a test set, as it is not a diagnostic device requiring such evaluation. The safety and effectiveness are established through comparison with predicate devices and bench testing.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no described "test set" or clinical evaluation requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., imaging software) to evaluate interpretative performance by human readers with and without AI assistance. The HALOFLEX Energy Generator is a therapeutic device (electrosurgical coagulation system), and its evaluation focuses on safety, fundamental scientific technology, and equivalent performance to existing devices, not on improving human reader performance.

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

The concept of "standalone performance" for an algorithm is not applicable to the HALOFLEX Energy Generator. This device is an energy generator for electrosurgical coagulation, which is inherently a human-in-the-loop therapeutic procedure. Its performance is evaluated on its ability to deliver energy safely and effectively, not as an autonomous algorithm. The "performance data" mentioned refers to bench testing to ensure the device's functional integrity.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus on imaging) is not directly applicable here. The "ground truth" for affirming the device's safety and effectiveness relies on:

• Bench testing results: Demonstrating compliance with engineering specifications and safety standards.
• Comparison to predicate devices: The established safety and effectiveness of the existing HALO360, HALO90, and RF 3000 generators serve as a de facto "ground truth" for what is considered safe and effective performance for this class of device.
• Regulatory standards: Compliance with international and domestic requirements acts as a standard for acceptable performance.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The HALOFLEX Energy Generator is a hardware device with embedded software, not a machine learning model that undergoes "training" on a dataset. The software updates mentioned are for "specific performance characteristics" and "optimization of components," not for an AI algorithm trained on a dataset.

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

This information is not applicable/not provided for the same reasons as point 8.

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The HALO® System (inclusive of the HALO® Ablation Catheter) 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, and Angiodysplasia.

The HALO90 System consists of the following components:

• HALO" Energy Generator model 1100C-115C and 90-9100 and . accessories (output cable, and an optional footswitch).
• A single use HALO90 Ablation Catheter model 90-9100 .
  The HALO® System performance and mode of operation did not change. This 510 (k) addresses the name change for the catheter.
  There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO® Ablation catheter model 90-9100 when compared with the predicate device HALO® Coagulation Catheter model 90-9100.
  The following changes are subject to this 510k submission: HALO® Coagulation Catheter model 90-9100 was marketed in Europe and Canada as HALO90 Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO® Coagulation Catheter to HALO90 Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.
  There are no changes associated to the HALO® Energy Generator software, hardware and accessories.

The provided text describes a 510(k) submission for the BARRX Medical HALO® Ablation Catheter. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary explicitly states:
"The HALO® System performance and mode of operation did not change. This 510 (k) addresses the name change for the catheter."
and
"There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO® Ablation catheter model 90-9100 when compared with the predicate device HALO® Coagulation Catheter model 90-9100."
and
"There are no differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent."

This submission is solely about a name change for an already cleared device ("HALO® Coagulation Catheter" to "HALO90 Ablation Catheter") to unify international and domestic labeling. Therefore, no new performance studies or acceptance criteria are presented for this specific submission as the device itself is considered identical to its predicate.

As a result, I cannot populate the requested table or provide information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this data is not present in the provided document. The 510(k) relies on the substantial equivalence to the predicate device, K062723, which would have had such studies.

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The HALO360+ Ablation Catheter intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO360+ Ablation Catheter 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, and Angiodysplasia.

The HALO360 System consists of the following components:

• HALO360 Energy Generator model 1100C-115B and 1100C-230B . and accessories (output cable, and an optional footswitch).
• A single use HALO360 Sizing Balloon model 3441B,
• A single use HALO360+ Ablation Catheter model 32041-xx with an optional accessory HALO Cap

The HALO360 System performance and mode of operation did not change. This 510 (k) addresses the addition of the optional accessory HALO Cap.

There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO360+ Ablation catheter model 32041-xx when compared with the predicate device HALO360+ Coagulation Catheter model 32041-xx. The following changes are subject to this 510k submission:

• Based on feedback received from the physician-user, BARRX Medical identified the need for an optional accessory HALO Cap for the use with HALO30 + Coagulation Catheter. This accessory will-facilitate removal of biological debris.after treatment and as result minimize the time;of the ¿ procedure.
• HALO360+ Coagulation Catheter model 32041-xx was marketed in Europe and Canada as HALO360+ Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO360+ Coagulation Catheter to HALO360+ Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.

This 510(k) summary (K083711) for the BARRX Medical HALO360+ Ablation Catheter does not describe a study to prove acceptance criteria with specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a modified version of an existing device.

Here's an breakdown of why the requested information cannot be fully provided from this document and what can be extracted:

The primary purpose of this 510(k) submission is to:

1. Introduce an optional accessory, the HALO Cap, for the HALO360+ Ablation Catheter to facilitate debris removal and reduce procedure time.
2. Change the device name from "HALO360+ Coagulation Catheter" to "HALO360+ Ablation Catheter" for international and domestic labeling consistency.

The submission explicitly states: "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent." This indicates that the regulatory pathway relied on demonstrating that the changes did not negatively impact the existing device's safety and efficacy, rather than conducting a new clinical study to establish performance against pre-defined acceptance criteria for the entire device.

Therefore, many of the requested details related to a clinical study (like sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance) are not present in this document because such a study was not deemed necessary for this particular submission.

Here's what can be extracted and inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable. Since this 510(k) is for demonstrating substantial equivalence based on minor modifications (an accessory and a name change), there are no specific, quantitative acceptance criteria and corresponding performance metrics presented in this document for the device as a whole or for the new accessory's performance. The "acceptance criteria" here implicitly relate to demonstrating that the addition of the HALO Cap does not degrade the safety and effectiveness of the existing device.

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

• Sample Size: Not applicable/Not specified. The document states "evaluated on bench," implying non-clinical testing rather than patient-based clinical testing. No specific number of samples or tests is provided.
• Data Provenance: Not applicable. The evaluation was "on bench," suggesting laboratory or engineering testing, not data from human subjects or clinical settings, either retrospective or prospective.

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

• Not applicable. No expert ground truth establishment for a test set is described. The evaluation was "on bench," likely performed by engineers or technical personnel rather than clinical experts establishing ground truth in a diagnostic context.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method is described, as there was no clinical test set requiring expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not conducted or mentioned. This type of study focuses on human reader performance with and without AI, which is not relevant to this submission for a physical device and its accessory.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• No. This device is a physical electrosurgical catheter, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

• Not applicable. Given that the evaluation was "on bench" for changes to a physical device and an accessory, the "ground truth" would likely relate to engineering specifications, material properties, electrical performance, and mechanical function, rather than clinical outcomes, pathology, or expert consensus. No specific type of "ground truth" (e.g., pathology, outcomes) is mentioned.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device and an accessory, not a machine learning algorithm that requires a training set.

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

• Not applicable. As above, no training set or associated ground truth establishment is relevant to this device submission.

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The HALO360 Energy Generator intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO360 Energy Generator 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, and Angiodysplasia.

The HALO360 Coagulation System consists of the HALO360 Energy Generator model 1100C-115B with a disposable single-use HALO®60 Coagulation Catheter, output cable, and an optional footswitch. The HALO360 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO360 Coagulation System, and Stellartech Coagulation System 2.

There are no changes associated to the HALO360+ Coagulation Catheter.

The HALO360 Energy Generator model 1100C-115B is configured with an output cable (model CCC-001B), an optional footswitch (model FS-100B), and a power cord.

There are no changes to the hardware associated to HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. There are minor changes implemented to the software version of the generator.

This submission addresses software changes for HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy.

This 510(k) summary describes a device modification, not a study establishing new acceptance criteria or performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided document.

The submission focuses on minor software changes to the HALO360 Energy Generator and demonstrates substantial equivalence to previously cleared devices. It confirms that "These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy."

Here's a breakdown of what can be extracted from the document based on your request:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission states that the differences were evaluated on bench, implying functional testing was performed to ensure the software changes did not negatively impact performance, but specific acceptance criteria and detailed performance results are not reported. The primary claim is substantial equivalence based on the absence of new safety or efficacy questions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench" evaluation, which typically involves laboratory testing rather than testing on a "test set" of patient data as might be relevant for AI/diagnostic devices.

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)

This information is not provided in the document. This is not applicable as the submission is about a software update for an electrosurgical generator, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document and is not applicable for this type of device modification 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

This information is not provided in the document and is not applicable. The device is an energy generator for coagulation, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not provided in the document. This is not directly applicable. The device is a hardware generator with software control, not a standalone algorithm. Its performance is demonstrated through its function, not through an "algorithm only" evaluation in the context of an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. The ground truth for such a device would typically be its ability to perform its intended coagulation function safely and effectively, which would be assessed through engineering and bench testing, not expert consensus or pathology in this context.

8. The sample size for the training set

This information is not provided in the document. This concept is not applicable as the device is not an AI algorithm that undergoes "training" on a dataset in the conventional sense. The "software changes" were likely developed and tested internally rather than trained on a distinct dataset.

9. How the ground truth for the training set was established

This information is not provided in the document and is not applicable.

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The HALO366 Coagulation Catheter is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO360 Coagulation Catheter 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, and Angiodysplasia.

The HALO360 Coagulation System consists of the HALO300 Energy Generator with a disposable single-use ablation catheter HALO360+ Coagulation Catheter and HALO360 Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation Catheter comprises models 31041-XX and 32041-XX equivalent in performance and mode of operation. There are no changes to the design, principle of operations for any of the products included in the HALO360 System.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that Barrx Medical's HALO360 Coagulation Catheter and HALO360+ Coagulation Catheter meet such criteria.

The document is a 510(k) summary for a premarket notification to the FDA. It does contain:

• Device Name: HALO360 Coagulation Catheter and HALO360+ Coagulation Catheter.
• Intended Use/Indications for Use: Coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific conditions like Esophageal Ulcers, Mallory-Weiss tears, etc.
• Technological Characteristics: Describes the system components (Energy Generator, disposable catheters, sizing balloon, cable, footswitch) and states no changes to design or principle of operations.
• Substantial Equivalence: The submission is primarily about Instructions for Use (IFU) changes (adding a contraindication for "Eosinophilic esophagitis" and clarifying instructions) for devices that did not undergo product or process changes. It asserts that these changes do not affect device use or performance and do not raise questions about safety and efficacy, thus concluding substantial equivalence to existing predicate devices (K071543 HALO360+ Coagulation Catheter and K062225 HALO360 Coagulation Catheter).
• FDA Clearance: The letter from the FDA confirms market clearance based on substantial equivalence.

The document explicitly states that the devices did not undergo any product or process changes and that the submission addresses only changes to the instructions for use. Therefore, there is no discussion of new acceptance criteria, performance studies, or data related to the device's technical specifications or clinical effectiveness to demonstrate meeting those criteria in this document.

For the information you requested regarding acceptance criteria and performance studies, you would typically need to refer to a different type of document, such as a PMA (Premarket Approval) submission, clinical trial results, or a more detailed technical report which are not present in this 510(k) summary.

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