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510(k) Data Aggregation
(336 days)
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
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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(48 days)
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
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 (
This document is a marketing approval letter from the FDA for the Sirius Pintuition Seed, Sirius Pintuition Probe, and Sirius Pintuition Base Unit, with a focus on a modification related to the resterilization of the Sirius Pintuition Probe. As such, the information provided primarily relates to demonstrating the substantial equivalence of the modified device to its predicate, rather than a full, de novo study proving the initial efficacy of the entire system.
Therefore, many of the requested data points (like sample size for test set, number of experts for ground truth, MRMC study, training set size, etc.) are not explicitly present in the provided text as this is a 510(k) "Special" submission, indicating a modification to an already cleared device. The focus is on verifying the impact of the modification (resterilization) on safety and performance, rather than re-proving the original device's effectiveness.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the device's overall performance (e.g., specific accuracy metrics). Instead, it focuses on demonstrating that the modification (resterilization) does not negatively impact the established safety and performance of the device.
The reported device performance is largely a qualitative statement of comparability to the predicate device due to the nature of a Special 510(k).
| Acceptance Criteria (Implied for Modification) | Reported Device Performance |
|---|---|
| Probe Sterility (after resterilization) | Sterilization in STERRAD NX and NX100 systems is validated and implemented. The modification allows for sterilization, removing the mandatory sterile sheath requirement if sterilized. |
| Functional Compatibility (after resterilization) | Testing was conducted to evaluate "functional compatibility" of the modified device after resterilization. (Specific results are not detailed, but the conclusion of substantial equivalence implies satisfactory performance). |
| Overall Safety and Performance of the Sirius Pintuition Localization System (post-modification) | "The Sirius Pintuition Localization System has the same Intended Use as the predicate device (K200734). The device is identical, apart from the changes proposed related to (re)sterilization of the Probe in STERRAD NX and NX100 systems. These changes do not impact substantial equivalence..." |
| Biocompatibility (after resterilization, if applicable to new probe material/interaction) | Biocompatibility evaluation was conducted. (Assumed satisfactory, as no adverse findings are mentioned). |
| MR Safety Testing (after resterilization, if applicable to any new material or component interaction) | MR safety testing was conducted. (Assumed satisfactory). |
| Electrical Safety Testing (after resterilization, if applicable to any changes in electrical components/housing) | Electrical safety testing was conducted. (Assumed satisfactory). |
| Packaging Validation (for new or affected components) | Packaging validation was conducted. (Assumed satisfactory). |
| Shelf Life Validation (for new or affected components) | Shelf life validation was conducted. (Assumed satisfactory). |
| Design Verification | Design verification was conducted. (Assumed satisfactory). |
| System Accuracy and Range Verification | System accuracy and range verification was conducted. (Assumed satisfactory and unchanged from predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The testing involved "ADDITIONAL: Sterilization validation and functional compatibility testing" along with other elements like design verification, system accuracy/range verification, biocompatibility, MR safety, packaging, shelf life, and electrical safety. These tests would involve various samples of the device and its components, but specific numbers are not given.
- Data Provenance: Not explicitly stated, though Sirius Medical Systems B.V. is based in the Netherlands. The tests are described as "pre-clinical testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/specified. This document describes pre-clinical validation studies relating to a device modification (resterilization), not a study evaluating human performance or diagnostic accuracy that would typically involve expert-established ground truth on a test set of clinical cases.
4. Adjudication Method for the Test Set
Not applicable/specified. This type of information is generally relevant for studies involving human interpretation or diagnostic decision-making using images or clinical data, where conflicting expert opinions might need to be resolved. This document pertains to validation of a physical device modification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this particular submission. The submission is a "Special 510(k)" for a modification (resterilization of the probe) to an already cleared device. MRMC studies are typically used to evaluate the diagnostic accuracy of the entire system (algorithm + human reader) in clinical use, which would have been part of the original device's clearance or a new, significant indication. This document references a "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," but this is not the same as an MRMC study on the effectiveness of AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The Sirius Pintuition System is a localization system that relies on a physical probe and magnetic seed for non-imaging detection and localization, guided by a human user. There isn't an "algorithm-only" component in the sense of an AI-driven image analysis tool. The device provides "audible and visual cues (distance in mm)" to the user.
7. The Type of Ground Truth Used for the Test Set
The concept of "ground truth" in the context of this submission (a device modification for resterilization) is related to objective physical and biological parameters:
- Sterility Validation: Absence of viable microorganisms after sterilization.
- Functional Compatibility: The device operating within specified performance parameters (e.g., accuracy, range) after resterilization.
- Biocompatibility: Absence of adverse biological reactions to the device materials.
- Safety Standards: Compliance with electrical safety and MR safety standards.
These are established through laboratory testing and engineering verification, not typically through expert consensus, pathology, or outcomes data in the typical sense for diagnostic algorithms.
8. The Sample Size for the Training Set
Not applicable/specified. The Sirius Pintuition System is a magnetic localization device, not an AI/machine learning algorithm that requires a "training set" in the traditional sense of image or clinical data for model development. The system operates based on established physical principles of magnetism.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned above, there isn't a "training set" for this type of device. The system's functionality is based on physics and engineered specifications.
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(341 days)
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
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.
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