(341 days)
The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (
The Sirius Pintuition Seed and Sirius Pintuition Detector are part of the Sirius Pintuition Localization System.
The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is intended to be placed percutaneously in the breast for temporary (
The provided text is a 510(k) Premarket Notification for the Sirius Pintuition Localization System. While it discusses the device's intended use, technological characteristics, and a summary of non-clinical and clinical performance data, it does not explicitly detail a study proving the device meets acceptance criteria in the format or with the specific quantitative data requested in your prompt.
Specifically, the document states:
- "Testing was conducted to evaluate and characterize the safety and performance of the Sirius Pintuition Localization System. Pre-clinical testing included: Design verification, System accuracy and range verification..." (page 18, section 5.7). This indicates that such tests were performed, but the document does not provide the acceptance criteria table or the reported device performance results from these tests.
- "An analysis of available data was conducted to evaluate and characterize the clinical safety and performance of the Sirius Pintuition Localization System. The clinical data support the safety and effectiveness of the device: Clinical Evaluation, including clinical safety and performance data with the actual device, a previous version of the device and an extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices." (page 18, section 5.8). This describes a clinical evaluation based on various data sources, but it does not outline a specific comparative clinical study (like an MRMC study) or provide details on how "safety and effectiveness" were quantified for this specific device against defined criteria.
Therefore, I cannot extract the information required to populate the fields in your request comprehensively from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing quantitative performance against specific acceptance criteria in a comprehensive study report.
In summary, the document lacks the specific details required for:
- A table of acceptance criteria and reported device performance: No such table or detailed performance data is present.
- Sample size and data provenance for the test set: Not specified for any quantitative clinical or performance test.
- Number of experts and qualifications for ground truth: Not applicable as no explicit 'ground truth' establishment for a diagnostic test is described.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study details (effect size, human readers improvement): No such study is mentioned or detailed. The clinical evaluation refers to literature reviews and data from previous versions/predicate, not a direct human reader study with this device.
- Standalone (algorithm only) performance: Not applicable, as this is a physical device, not an AI algorithm.
- Type of ground truth used: Not applicable for device performance (rather than diagnostic accuracy).
- Sample size for training set: Not applicable, as it's not an AI model.
- How ground truth for training set was established: Not applicable.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.