(14 days)
The Cianna S1, Single Lumen Balloon Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
The Cianna S1 Single Lumen Balloon Applicator is a specialized applicator that is temporarily inserted into the target volume to facilitate the application of radiation to the target site in the treatment of carcinoma. The Cianna S1 Single Lumen Balloon Applicator is provided sterile for single use and is disposable.
The provided text describes the Cianna S1, Single Lumen Balloon Applicator, a medical device for brachytherapy. However, the text does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/ML context.
The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance studies with acceptance criteria in the way a clinical or AI/ML performance study would.
Here's a breakdown of what is provided and what is missing based on your request:
Acceptance Criteria and Reported Device Performance
The provided text states: "Performance testing was conducted to evaluate and characterize the performance of the Cianna S1 Single Lumen Balloon Applicator. Preclinical testing conducted included valve and syringe stability, balloon inflation diameter assessment, afterloader compatibility, closed system verification and biocompatibility testing per ISO 10993-1. The Cianna S1 Single Lumen Balloon Applicator performed as intended and met all acceptance criteria."
This is a general statement. Specific acceptance criteria (thresholds or metrics) and the detailed results demonstrating how those criteria were met are NOT provided in the text. For example, it doesn't specify what the acceptable range for "balloon inflation diameter" was, nor the actual measured diameter.
| Acceptance Criteria (Specifics Not Provided) | Reported Device Performance |
|---|---|
| Valve and syringe stability | Performed as intended |
| Balloon inflation diameter assessment | Performed as intended |
| Afterloader compatibility | Performed as intended |
| Closed system verification | Performed as intended |
| Biocompatibility (per ISO 10993-1) | Performed as intended |
Information NOT available in the provided text, as it pertains to AI/ML or detailed clinical study specifics:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is neither an AI/ML device nor a clinical trial report with a test set of patient data. The "testing" mentioned refers to engineering and biocompatibility checks.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.