(84 days)
"Best® Multi-Lumen Balloon Applicator for Brachytherapy" is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician.
The Best® device is a multi-catheter brachytherapy device consisting of an inflatable outer spherical balloon and an inner inflatable balloon for treatment catheter positioning. Each catheter can be attachment to a commercially available High Dose Rate remote afterloader for passage of the source wire and radiation source into each of the catheter lumens. Five treatment lumens are provided, one central lumen located along the long axis of the applicator and four moveable lumens, which are symmetrically offset from the central lumen by inflation of an inner balloon, which positions the treatment lumens at a location greater than or equal to 50% of the outer balloon diameter. A removable stiffening stylet is positioned in the central treatment lumen for initial placement into the resection cavity, as well for repositioning of the device as needed. Three proximal ports are also provided with Luer-locktype connectors for inner and outer balloon inflation/deflation and for application of intracavitary vacuum for removal of air and/or fluid.
The document provided is a 510(k) Summary for a medical device called the "Best® Multi-Lumen Balloon Applicator for Brachytherapy." This device is a physical medical instrument, not a software-based AI/ML device. Therefore, the typical acceptance criteria and study designs applicable to AI/ML devices, such as those related to diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not relevant or provided in this submission.
The acceptance criteria and "study" described in this document are focused on the physical and functional performance of the device, primarily by demonstrating substantial equivalence to a legally marketed predicate device.
Here's an analysis of the provided information, framed within the context of a physical medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one would for a diagnostic accuracy study. Instead, it demonstrates performance through functional testing and comparison to a predicate device. The implicit acceptance criteria are that the device performs its intended mechanical functions reliably and safely, similar to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | "The Best® Multi-Lumen Balloon Applicator for Brachytherapy performed as intended." |
| Dimensional integrity of the inflated outer balloon | "Performance tests were conducted to evaluate and characterize the performance... These tests included dimensional comparisons of the inflated outer balloon at various volumes." (No specific values reported, but implies acceptable performance) |
| Smooth HDR source transition in and out of catheters | "Performance tests... included HDR source transition in and out of the treatment catheters on an inflated inner balloon." (Implies successful, smooth transition) |
| Adequate CT Image Quality | "Performance tests... included... CT image quality." (Implies the device is visible and distinguishable on CT scans as needed for brachytherapy planning) |
| Similarity in Design Characteristics to Predicate Device | "They have similar design characteristics; same operating principle and similar technological characteristics." |
| Intended Use matching Predicate Device | The "Best® Multi-Lumen Balloon Applicator for Brachytherapy" has the same intended use as the predicate device. |
| Indications for Use matching Predicate Device | The "Best® Multi-Lumen Balloon Applicator for Brachytherapy" has the same indications for use as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of human data or AI model evaluation. The "tests" performed were engineering and functional assessments of the physical device. The sample size would refer to the number of physical devices tested, which is not specified but is typically a small number for design verification.
- Data Provenance: Not applicable. This is not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Ground truth in this context relates to the physical and mechanical properties and functionality of the device, which are established through engineering measurements and design specifications, not expert interpretation of medical images or outcomes.
4. Adjudication Method for the Test Set:
- Not applicable. There is no "adjudication" in the sense of reconciling divergent expert opinions on medical diagnoses. Performance is assessed against engineering specifications and functional requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the function of this physical brachytherapy applicator.
- Effect Size of Human Readers with/without AI assistance: Not applicable.
6. If a Standalone (Algorithm Only without Human-in-the-Loop Performance) was done:
- Not applicable. This device is a physical instrument used by a human physician, not a standalone algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on engineering specifications, manufacturing tolerances, and the demonstrated functional behavior of the device (e.g., successful balloon inflation, unimpeded source wire movement, acceptable imaging properties) when subjected to defined tests. The comparison to the predicate device's established safety and effectiveness also serves as a benchmark for "ground truth" regarding substantial equivalence.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical device, and there is no "training set" in the context of AI/ML model development.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reason as above.
In summary: The provided document is a 510(k) submission for a physical medical device. It demonstrates safety and effectiveness through mechanical performance testing and a detailed comparison to a legally marketed predicate device, rather than through clinical trials or performance studies relevant to AI/ML diagnostic tools. The "study" here is a series of engineering and functional tests to confirm the device operates as intended and meets design specifications, ensuring it is substantially equivalent to the predicate.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.