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The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).

The Barrx™ Anorectal RFA Wand is a sterile, single-use, bipolar device used to deliver radiofrequency (RF) energy to treatment tissue in the anal canal and rectum. The Barrx™ Anorectal RFA Wand consists of a cap with electrode, EEPROM, a proximal shaft and a rigid distal shaft with handle. The device is used exclusively in connection with the Barrx™ Flex RFA Energy Generator (K092487). Once the device is connected, the EEPROM is read by the generator, recognizes the device, and determines the operation parameters.

This document is a 510(k) summary for the Barrx™ Anorectal RFA Wand, seeking to include Anal Intraepithelial Neoplasia (AIN) as a specific indication for use, with clinical information from three AIN-related studies. However, the document explicitly states that no performance testing was conducted for the device itself because it is technologically identical to a previously cleared predicate device (K150251) and a reference predicate device (K112454).

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria, as such a study was not performed as part of this 510(k) submission for the device itself.

Instead, the submission relies on clinical studies demonstrating the use of the Barrx™ Anorectal RFA Wand for AIN, implying these studies serve as the basis for the extended indication. However, the document does not detail the methodology, acceptance criteria, or specific results of these AIN-related clinical studies. It only mentions their existence and that they support the substantial equivalence claim for the new indication.

Based on the provided text, I can answer some of your questions regarding the AIN-related clinical studies, but not for the device's technical performance validation:

Regarding the AIN-related clinical studies mentioned in the 510(k) submission:

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

   • Not provided. The document states that clinical studies were referenced to demonstrate the device's use for AIN, but it does not detail any specific acceptance criteria or performance metrics for these studies.

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

   • Not provided. The document mentions "three AIN related clinical studies" but does not specify their sample sizes, data provenance, or whether they were retrospective or prospective.

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 provided. The document does not describe how ground truth was established for the AIN-related clinical studies.

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

   • Not provided.

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 device is an electrosurgical RFA wand, not an AI-based diagnostic or assistive device for human readers.

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

   • Not applicable. This is a medical device, not an algorithm.

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

   • Not provided. For the AIN-related clinical studies, the specific type of ground truth used (e.g., histological confirmation of AIN resolution, clinical improvement) is not detailed.

8. The sample size for the training set:

   • Not applicable / Not provided. The device is not an AI algorithm; therefore, it does not have a "training set" in the context of machine learning. If "training set" refers to data used to inform the design or understanding of the device's use for AIN, this information is not provided.

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

   • Not applicable / Not provided. As above, the concept of a training set ground truth, as typically defined for AI, does not apply here.

Summary regarding the device's technical performance:

• No new performance testing was conducted for the Barrx™ Anorectal RFA Wand for this submission.
• The manufacturer stated that the subject device is "technologically identical" to its predicate devices (K150251 and K112454).
• The basis for the new indication (AIN) relies on "clinical studies referenced within this submission" that "demonstrate the Barrx™ Anorectal RFA Wand may be used for anal intraepithelial neoplasia." However, the details of these clinical studies (methodology, results, acceptance criteria, sample sizes, etc.) are not included in this 510(k) summary.

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