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The C2 CryoBalloon™ Ablation System is intended to be used as a cryosurgical tool in the field of general surgery. specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia and treatment and management of Gastric Antral Vascular Ectasia (GAVE).

The subject device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working chamel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use). The system also includes NitroClip as an accessory that is intended to reduce the nitrous oxide exposure in the room.

The subject device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

The provided document is a 510(k) Premarket Notification from the FDA for the C2 CryoBalloon Ablation System. It outlines the device's indications for use, technological characteristics, and performance data. However, it does not contain specific acceptance criteria with quantifiable metrics, nor does it detail a study explicitly designed to prove the device meets pre-defined acceptance criteria for an AI/CADe device.

The document describes clinical testing to support the device's safety and effectiveness for new indications (GAVE) and a new treatment dose for Barrett's Esophagus. This is different from the type of study typically performed to validate an AI/CADe system against specific performance metrics for diagnostic accuracy.

Therefore, I cannot fulfill all parts of your request as the provided text does not describe an AI/CADe system or a study proving its acceptance criteria in the manner you've requested. The device described, the C2 CryoBalloon Ablation System, is a cryosurgical tool and not an AI or CADe system.

However, I can extract and structure the information available regarding the performance studies that were conducted for this surgical device.

Based on the provided document, here's an analysis of the performance data for the C2 CryoBalloon Ablation System, interpreted in the context of what was evaluated, rather than specific AI/CADe acceptance criteria:

The performance data presented in the document pertains to the surgical effectiveness and safety of the C2 CryoBalloon Ablation System for its stated indications, not the diagnostic performance of an AI system.

Summary of Device Performance and Related Studies:

The document describes:

• Bench Testing: To verify temperature profiling, spray radius, and spray uniformity of the 180 Standard catheter at different speeds (1.0 mm/s and 1.2 mm/s).
• Clinical Testing:
  • Gastric Antral Vascular Ectasia (GAVE): A multi-center retrospective study.
  • 180° Catheter Treatment Dose (Barrett's Esophagus): Two studies, one dose-finding (1.0mm/s) and one multi-center (1.2mm/s).

As there are no specific "acceptance criteria" provided in a table format for an AI/CADe device, nor a study proving meeting those, I will present the key outcomes and performance metrics reported for the clinical studies.

Simulated Table of "Acceptance Criteria" and Reported Device Performance (based on clinical outcomes, not AI/CADe metrics):

Breakdown of Information as per Request (adapted to the available data for a surgical device):

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

   • See the simulated table above. The "acceptance criteria" are inferred from the outcomes measured and deemed acceptable by the manufacturer and FDA for substantial equivalence. These are not AI/CADe specific accuracy metrics.

2. Sample sizes used for the test set and the data provenance:

   • GAVE Study:
     • Sample Size: 28 subjects (retrospective study).
     • Data Provenance: Not explicitly stated, but compared to a published study of 33 GAVE patients from "three tertiary referral centers in the United States." This suggests the retrospective data for the C2 CryoBalloon system were likely from similar clinical settings, though the specific country of origin is not given. It was a retrospective study.
   • BE Study (1.0mm/s dose):
     • Sample Size: 25 patients.
     • Data Provenance: Not explicitly stated regarding country, but described as a "dose-finding phase."
   • BE Study (1.2mm/s dose):
     • Sample Size: 25 patients.
     • Data Provenance: Described as a "multicenter study." Not explicitly stated regarding country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of this surgical device. The "ground truth" for GAVE or BE treatment success/eradication would be based on endoscopic findings, histological analysis, and clinical outcomes (e.g., hemoglobin levels, transfusion independence) as determined by treating physicians, not expert readers establishing a consensus for image interpretation. No specific number of experts or their qualifications for "ground truth establishment" are mentioned.

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

   • Not applicable as this is not an image-based diagnostic AI/CADe study requiring adjudication of interpretations. Clinical outcomes were measured directly.

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:

   • No MRMC study was done, as this is not an AI/CADe device. The comparisons are between the C2 CryoBalloon system and "other modalities" (e.g., APC, RFA) for GAVE treatment, or different doses/catheters for BE treatment.

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

   • Not applicable; this is a human-operated surgical device, not a standalone algorithm.

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

   • The "ground truth" for these clinical studies relied on:
     • Clinical Outcomes Data: Mean number of packed red blood cells (PRBC) transfused, transfusion independence, blood hemoglobin levels for GAVE.
     • Endoscopic Findings: GAVE eradication, BE surface regression.
     • Adverse Events: Occurrence and severity of complications like strictures, bleeding.
     • These are direct clinical and procedural outcomes, not interpretations of diagnostic images.

8. The sample size for the training set:

   • Not applicable. This is a medical device, not a machine learning model that undergoes "training." The described studies are clinical evaluation studies, akin to validation/test sets for demonstrating safety and efficacy.

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

   • Not applicable, as no machine learning training set is involved.

Conclusion based on the provided document:

The provided document refers to the FDA's 510(k) clearance for the C2 CryoBalloon Ablation System, a surgical device. The performance data presented focuses on the safety and effectiveness of the surgical intervention for specific indications (Barrett's Esophagus with dysplasia and Gastric Antral Vascular Ectasia). It outlines clinical study results (retrospective and multi-center studies) and bench testing results. The information requested regarding AI/CADe acceptance criteria, MRMC studies, AI training/test sets, and expert consensus/adjudication for diagnostic ground truth is not applicable to this type of device and the studies described.

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The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.

The Barrx FLEX RFA Energy Generator 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 and Angiodysplasia.

The subject device, the Barrx™ FLEX RFA Energy Generator is intended to be used with the listed catheters to deliver radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The Generator is provided with a footswitch that can initiate inflation or deflation of the balloon and initiate or cease delivery of RF energy. The Barrx FLEX RFA Energy Generator is designed to function with a family of single use, disposable Ablation Catheters and Sizing Balloons to deliver the intended therapy.

This document is a 510(k) premarket notification for a medical device called the Barrx FLEX RFA Energy Generator. It's a submission to the FDA (Food and Drug Administration) for a device that already has a predicate (K141357), and the current submission is primarily for a labeling change to add new clinical information.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered device or a study involving human readers and AI assistance.

The document pertains to an electrosurgical device used for coagulation of soft tissue, specifically in the gastrointestinal tract. The "study" mentioned (Wolf WA, Pasricha S, Cotton C, et al. Incidence of Esophageal Adenocarcinoma and Causes of Mortality After Radiofrequency Ablation of Barrett's Esophagus. Gastroenterology 2015; Aug 28. [Epub ahead of print]) is a clinical study whose results were added to the device's labeling, not a performance study in the sense of testing an AI algorithm's accuracy or impact on human performance.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML-based device or a comparative effectiveness study involving human readers and AI assistance, as these concepts are not applicable to the content of this 510(k) submission.

The document explicitly states:

• "As the subject of this submission is a labeling change only, the Barrx FLEX RFA Energy Generator has identical technological characteristics as compared to the predicate Barrx FLEX RFA Energy Generator (K141357)."
• "There have been no design or material changes to the generator since the predicate was cleared on."
• "There has been a minor software change since the K141357 however, it did not require a submission and was documented via Letter to File to K141357."
• "The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K141357) is the addition of clinical information to the labeling resulting from one published peer-reviewed clinical study."

This clearly indicates that the submission is not about a new performance study testing an AI component or its impact on human readers.

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The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of 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 subject device, the Barry™ Barrx FLEX RFA Energy Generator is intended to be used with the listed catheters to deliver radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheters include:

• HALO360 Ablation Catheter and Sizing Ballon (K093855)
• . HALO90 Ablation Catheter (K093008)
• HALO60 Ablation Catheter (K112454) ●
• HALO® ULTRA Ablation Catheter (K120431) ●
• . Barrx Channel RFA Endoscopic Catheter (K130623)

The Barrx FLEX RFA Energy Generator is an electrosurgical device that utilizes bipolar RF energy to coagulate biological tissue. The Generator is provided with a footswitch that can initiate inflation of the balloon and initiate or cease delivery of RF energy. The Barrx FLEX RFA Energy Generator is designed to function with a family of single use, disposable Ablation Catheters and Sizing Balloons to deliver the intended therapy.

This document describes a 510(k) premarket notification for the Barrx FLEX RFA Energy Generator. The submission is for a labeling change only, meaning the device itself has not undergone design or material changes, and its technological characteristics and principles of operation are identical to its predicate device (K092487). The main difference is the addition of clinical information to the labeling, derived from two published peer-reviewed clinical studies.

Given this context, the request for acceptance criteria and a study proving device performance as typically understood for a new or modified device's technical capabilities is not directly applicable in the same way. This submission focuses on the clinical evidence supporting the expanded indications for use on the label, which are based on previously established device performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the typical sense of new performance metrics for the device hardware itself. Instead, the "acceptance criteria" here relate to the successful inclusion of expanded indications for use based on clinical evidence.

Here's a breakdown of the requested information based on the provided document:

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

Since this is a labeling change based on clinical studies, there aren't new device performance criteria. The "performance" being evaluated implicitly is the Barrx FLEX RFA Energy Generator's ability to effectively coagulate tissue for the expanded indications listed, as demonstrated by the previously published clinical studies.

Regarding the "study that proves the device meets the acceptance criteria":

The document explicitly states: "The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K092487) is the addition of clinical information to the labeling resulting from two published peer-reviewed clinical studies."

Therefore, the "studies" that "prove" the device meets the (expanded indication) acceptance criteria are these two published peer-reviewed clinical studies. The document does not provide details about these studies themselves (e.g., their titles, methodology, specific results, sample sizes, etc.). It only references their existence and their role in justifying the labeling changes.

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

The document does not provide details about the sample sizes, data provenance (country, retrospective/prospective nature) of the two referenced clinical studies. It only states they are "published peer-reviewed clinical studies."

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)

The document does not provide any information about experts or their qualifications for establishing ground truth within the context of the clinical studies.

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

The document does not provide any information about adjudication methods for the clinical studies.

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

The Barrx FLEX RFA Energy Generator is an electrosurgical device for tissue coagulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This is an electrosurgical device, not a standalone algorithm. Its function inherently involves human operation. Therefore, a "standalone algorithm only" performance study is not applicable.

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

The document does not provide specifics on the type of ground truth used in the two clinical studies. Given the nature of the device (coagulation of soft tissue for various gastrointestinal conditions), it is highly probable that the ground truth would involve:

• Clinical outcomes (e.g., cessation of bleeding, healing of ulcers, eradication of Barrett's epithelium).
• Endoscopic assessment by qualified endoscopists.
• Potentially histopathology/pathology for conditions like Barrett's Esophagus.

8. The sample size for the training set

The document does not mention a "training set" as this device is not an AI/machine learning algorithm that requires training. The clinical studies (referred to as "two published peer-reviewed clinical studies") would involve patient cohorts, but these are not "training sets" in the AI sense.

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

As explained above, there is no "training set" in the context of this device.

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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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