(583 days)
Best® Intraluminal Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intraluminal radiation to an existing body lumen such as the esophagus or bronchus. 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 single catheter brachytherapy device consisting of an inflatable distal spherical balloon for anchoring and/or stabilizing and a series of inflatable balloons for centering the treatment catheter within the lumen. The catheter can be attachment to a commercially available High Dose Rate remote afterloader for passage of the source wire and radiation source into the catheter lumen. A removable flexible guide cable is positioned in the central treatment catheter for initial placement in the existing body lumen. Proximal ports are also provided with Luer-lock type connectors for inflation of the distal anchoring/stabilizing balloon inflation/deflation and for inflation of the series of centering balloons, either simultaneously or individually.
The Best® Intraluminal Balloon Applicator for Brachytherapy underwent non-clinical performance testing to evaluate its functionality. No clinical performance data was collected or reviewed in support of this premarket notification.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional comparisons of inflation regions at various volumes | Performed as intended. Specific numerical acceptance criteria and corresponding performance metrics are not provided in the summary. |
| HDR source transition into and out of the treatment catheter | Performed as intended. Specific numerical acceptance criteria and corresponding performance metrics are not provided in the summary. |
| Device materials not significantly affected by radiation | Device is constructed of materials that are not significantly affected by radiation to which they will be exposed during the lifetime of the product (single use). Specific test methods or numerical criteria are not provided. |
| Effective sterilization | The device may be sterilized effectively. Method of sterilization is Ethylene Oxide. Specific test methods or numerical criteria are not provided. |
| No re-sterilization | The device will not be re-sterilized. This indicates the device is intended for single use. This is a design/usage criterion rather than a performance metric. |
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 specify the sample size used for the performance tests. The data provenance is not explicitly stated, but as it's part of a 510(k) summary for a US FDA submission, it can be inferred to be from the manufacturer's testing (likely in the US). The tests are non-clinical, implying prospective testing specific to this device.
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 applicable. This device underwent non-clinical performance testing, not a study requiring expert-established ground truth for diagnostic or clinical evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no expert-based ground truth was established.
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
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a physical medical device (applicator), not an AI diagnostic tool. No AI assistance is mentioned or involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For non-clinical performance tests, "ground truth" typically refers to engineering specifications and measurements rather than clinical ground truth derived from expert consensus, pathology, or outcomes data. The performance was evaluated against internal design specifications and functional requirements.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 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.