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510(k) Data Aggregation
(134 days)
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
| Acceptance Criteria | Device Performance |
|---|---|
| Biocompatibility | Device is fully biocompatible, demonstrating compliance with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization), ISO 10993-11 (systemic toxicity), and USP 151 (pyrogenicity). |
| Sterilization | Sterilization validation resulted in a Sterility Assurance Level (SAL) of 10-6, in accordance with ISO 11135:2014. |
| Mechanical Function | Device demonstrated that design specifications from design input are fulfilled and raises no safety concern. |
| Structural Integrity | Device demonstrated that design specifications from design input are fulfilled and raises no safety concern. |
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).
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