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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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