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510(k) Data Aggregation
(336 days)
The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue.
The Sirius Pintuition Detector is intended only for the non-imaging detection of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
The Sirius Pintuition Seed and Sirius Pintuition Detector (consisting of Base Unit and Probe) are part of the Sirius Pintuition Localization System.
The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. The device is supplied single-use, sterile and pre-loaded within its delivery needle (7cm, 12cm or 20cm length variants).
The Pintuition Detector is designed to detect the presence and proximity of the implanted Pintuition Seed. It consists of a mains-powered, table-top Pintuition Base Unit, and a cableconnected, reusable Pintuition Probe. Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during surgery to plan the surgical approach and quide surgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm).
The principle of operation is magnetism, the Pintuition Seed is associated with a magnetic field which the Pintuition Detector utilizes to determine the location of the Pintuition Seed.
Here's a summary of the acceptance criteria and study information for the Sirius Pintuition Seed, Sirius Pintuition Probe, and Sirius Pintuition Base Unit, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria for performance (e.g., a specific accuracy threshold or a certain rate of successful localization). Instead, it lists various pre-clinical tests and a clinical evaluation to demonstrate safety and performance.
However, based on the Summary of Technological Characteristics and the Summary of Non-Clinical Performance Data, we can infer the aspects that were evaluated to ensure the device performs as intended:
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| System accuracy and range | Verified through pre-clinical testing |
| Biocompatibility | Evaluated through pre-clinical testing |
| MR Safety | Tested through pre-clinical testing |
| Sterilization validation | Validated through pre-clinical testing |
| Packaging validation | Validated through pre-clinical testing |
| Shelf-life validation | Validated through pre-clinical testing |
| Electrical safety | Tested through pre-clinical testing |
| Compatibility with implanted AIMDs | Analyzed through pre-clinical testing |
| Clinical Safety and Performance | Supported by clinical evaluation and literature data |
| Functional operation as intended | Verified and validated through non-clinical testing |
| Meeting design specifications | Verified and validated through non-clinical testing |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "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 performance 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 in various soft tissue types."
- Sample Size: The document does not specify a numerical sample size for the test set of the clinical evaluation. It refers to "available data," "clinical safety and performance data," and "extensive evaluation of available literature data."
- Data Provenance: The data provenance is described as a combination of:
- Data from the "actual device" (implying prospective or recent retrospective studies specific to this version).
- Data from a "previous version of the device."
- "Extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices." This indicates that the provenance is varied and includes retrospective literature reviews.
- Country of Origin: The country of origin for the clinical data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). The clinical evaluation is broad and references existing clinical data and literature.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study and therefore does not provide an effect size for human readers with vs. without AI assistance. The device in question (Sirius Pintuition) is a localization system, not an AI software intended to assist human readers in image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The Sirius Pintuition system is designed to be used by a human operator ("Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during surgery to plan the surgical approach and guidesurgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm)").
Therefore, a standalone performance study without human-in-the-loop would not be applicable or relevant to its intended use, and the document does not describe such a study. The "System accuracy and range verification" under non-clinical data would assess the device's inherent capability, but always within the context of a user interacting with it.
7. Type of Ground Truth Used
Based on the description of the device's function (locating and surgically removing the target tissue along with the implanted seed), the ground truth for clinical evaluation would likely involve:
- Pathology: To confirm whether the resected tissue contained the target lesion and the implanted seed.
- Surgical Confirmation: Direct visual or palpation confirmation during surgery of successful seed and lesion removal.
- Imaging Confirmation: Post-operative imaging (e.g., X-ray, ultrasound) to confirm removal of the seed and, if applicable, the target lesion.
The document does not explicitly state "pathology" or "outcome data" as ground truth, but given the indication for surgical removal, these are the most logical forms of truth. The clinical evaluation supported "safety and performance," which inherently relies on such confirmation.
8. Sample Size for the Training Set
The Sirius Pintuition system is a hardware device for localization based on magnetic principles, not a machine learning or AI algorithm in the context of image analysis that typically requires a "training set." Therefore, the concept of a "training set" in the context of an algorithm or AI is not applicable to this device as described.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" doesn't apply to this type of device, this question is not relevant to the information provided.
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