Search Results

StentBoost Mobile is intended for use as a vascular x-ray interventional application. StentBoost Mobile provides high image quality visualization of stents in relation to vessels. StentBoost Mobile assists in the treatment of endovascular diseases by visualizing the placement and deployment of stents.

Device Description

StentBoost Mobile is a software product (iApp) intended to provide a high-resolution visualization of stents in vessels. It supports the physician in placing and deploying stents.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for StentBoost Mobile:

The provided text does not contain detailed acceptance criteria for specific performance metrics nor the specific study results that directly prove the device meets these criteria in a quantitative sense as might be expected for an AI/CADe device. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (StentBoost Rel. 4) through non-clinical performance testing and compliance with recognized standards.

Therefore, the table below will reflect the information that is present, noting where specific details are missing.

Acceptance Criteria and Device Performance for StentBoost Mobile

#	Acceptance Criteria	Reported Device Performance
1	Compliance with IEC 62304 Medical device software – Software life cycle processes.	"Software verification testing... has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures ... and the Privacy and Security requirements and mitigations have been implemented. Results demonstrated that all executed verification tests were passed."
2	Compliance with IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices.	"Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence... and demonstrate that StentBoost Mobile: complies with the aforementioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use."
3	Compliance with IEC 82304-1 Health software Part 1: General requirements for product safety.	"Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence... and demonstrate that StentBoost Mobile: complies with the aforementioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use."
4	Compliance with ISO 14971 Medical devices – Application of risk management to medical devices.	"Software verification testing... has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix ...have been implemented. Results demonstrated that all executed verification tests were passed."
5	Compliance with ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements.	"Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence... and demonstrate that StentBoost Mobile: complies with the aforementioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use."
6	StentBoost Mobile conforms to its intended use, claims, user needs, effectiveness of safety measures, and instructions for use.	"Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence of the subject device and demonstrate that StentBoost Mobile: ...meets the acceptance criteria and is adequate for its intended use."
7	Specific quantitative performance metrics related to image quality, stent visualization, placement, and deployment accuracy (e.g., sensitivity, specificity, spatial resolution, contrast-to-noise ratio, measurement accuracy, etc.)	Not specified in the provided text. The document relies on substantial equivalence to the predicate device, StentBoost Rel. 4, stating that the fundamental scientific technology (image processing algorithm) is the same, and differences do not raise new safety or effectiveness questions.

Additional Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "software verification testing" and "non-clinical validation testing" but does not provide details on the number of images or cases used in these tests.
- Data Provenance: Not specified. The data types (e.g., x-ray image sequences) are implied, but their origin (country, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not specified in the provided text. The document describes "non-clinical validation testing" and "software verification testing" but does not detail the involvement of human experts for establishing ground truth for evaluating performance. Since it's a software intended to assist physicians, the evaluation likely involves expert assessment, but the details are absent.
Adjudication method for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The proposed StentBoost Mobile did not require clinical study since substantial equivalence to the currently marketed and predicate device StentBoost was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness."
- Effect Size: Not applicable, as no MRMC study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: The verification and validation described are primarily focused on the software's functional and technical performance in isolation (e.g., meeting system requirements, safety measures, usability standards), rather than an explicit standalone clinical performance study in the sense of diagnostic accuracy. However, "non-clinical performance testing" refers to testing the device without human interaction, to ensure it meets technical specifications. The document implies that the device's image processing algorithm (the "fundamental scientific technology") is the same as the predicate, which had already established its standalone technical capabilities.
The type of ground truth used:
- Type of Ground Truth: Not explicitly stated. For the verification testing, the ground truth would be the expected output or behavior according to the System Requirements Specification and Risk Management Matrix. For the validation testing, the ground truth would be user needs, claims, and intended use as defined, which would be assessed against the software's output. Clinical-level ground truth (e.g., pathology, outcomes data, or expert consensus on stent placement accuracy in real cases) is not mentioned as part of the described studies.
The sample size for the training set:
- Training Set Sample Size: Not applicable. The document states that "The fundamental scientific technology provided in the subject device StentBoost Mobile and predicate device StentBoost Rel. 4 is same based on the following: Image processing algorithm." This implies that the device leverages an existing, already developed algorithm from the predicate, rather than being a newly trained AI model requiring a distinct training set. The focus is on the software's implementation on a new platform and ensuring standards compliance.
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable, as there is no mention of a new training set. The device utilizes an existing algorithm.

Ask a Question

Ask a specific question about this device

Page 1 of 1