Search Results

The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.

[BKMI2001]
The device has 6 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #6 valve corresponds with the proximal balloon. There is an indication balloon on each valve unit, which can indicate the inflated balloon. The distance between first marker printed on the main catheter and the distal tip is 19.8 cm. This device is disposable and designed for sterile and single use.

[BKMI2002]
The device has 8 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #8 valve corresponds with the proximal balloon. The distance between first marker printed on the main catheter and the distal tip is 40 cm. This device is disposable and designed for sterile and single use.

The provided text is a 510(k) summary for the "BRAXX" Esophageal Brachytherapy Applicator. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not describe a study involving an AI/software device that requires acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance improvement.

The "Performance Testing" section refers to mechanical tests for the physical device (Balloon Burst, Balloon Fatigue, Balloon Diameter and Volume, Leakage, Tensile Strength). These are not related to an AI algorithm's performance on a test set of data.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study proving device meets criteria for an AI/software device. The provided text is solely for a physical medical device.

To answer your request, if this were an AI/software device, the information would typically be found in a section detailing clinical performance studies or algorithm validation studies.

Ask a specific question about this device

The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use. For prescription use only

A main catheter with inflatable balloons

BRAXX Esophageal Brachytherapy Applicator

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes performance testing for a medical device (Esophageal Brachytherapy Applicator) based on physical and chemical properties and engineering principles, not on clinical or AI performance. Therefore, there is no mention of a "test set" in the context of clinical data, sample size, or data provenance (country of origin, retrospective/prospective). The testing involved laboratory-based evaluations of the device's materials, sterility, and mechanical properties.

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

Not applicable. The ground truth for the performance testing of this device was established based on recognized international and FDA standards for biocompatibility (ISO 10993 series, USP 151), sterilization (ISO 11135:2014), and mechanical testing. These standards define the acceptable limits and methodologies, and compliance is typically assessed by qualified laboratory personnel and engineers, rather than a panel of clinical experts establishing ground truth from patient data.

4. Adjudication Method for the Test Set

Not applicable. As described above, the performance testing involved laboratory evaluations against established standards, not a clinical test set requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a physical medical device (an applicator for brachytherapy), not an AI-powered diagnostic or decision-support tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was based on:

• Established International Standards: For biocompatibility (ISO 10993 series and USP 151) and sterilization (ISO 11135:2014).
• Design Specifications/Input: For mechanical function and structural integrity, ensuring the device met its intended engineering requirements.
  These are objective, quantitative, or qualitative measures derived from validated testing methodologies, rather than expert consensus on clinical cases, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI system that requires a training set.

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

Not applicable. (See point 8).

Ask a specific question about this device