(434 days)
"Vascular Tools 5" software program has been developed to aid in quantitative analysis of longitudinal vascular ultrasound images, particularly to determine vascular diameter and intima-media thickness, as well as their changes as depicted in brachial and carotid arterial ultrasound images.
"Vascular Tools 5" quantification software system is a state-of-the-art product for computer-aided assessment of vascular diameter, intima-media thickness derived from existing ultrasound images. Based on computer-aided detection of vessel wall borders within a region of interest of a single longitudinal ultrasound image or a sequence of longitudinal ultrasound images, vascular diameter and/or IMT are reported for each ultrasound image frame or a user-defined subset of image frames.
"Vascular Tools 5" is a proprietary software program for vascular ultrasound image quantification designed for installation on an IBM-PC-compatible personal computer and use with Windows 2000 r XP operating platform. It provides tools for display, selection, evaluation, and storage of multiple loops of vascular ultrasound image data. Furthermore, "Vascular Tools 5" facilitate impge on namprt of complete studies in "Vascular Tools 5" format, and the export of results into general spread sheets, databases, or in ASCII formats for further statistical analysis of study results by the users,
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Vascular Tools 5" device:
Important Note: The provided document is a 510(k) summary, which often provides a high-level overview. It states that "Detailed assessment of "Vascular Tools 5" performance is given in Appendix D." However, Appendix D is not included in the provided text. Therefore, several of the specific details requested below (especially regarding the test set, ground truth methods, and expert qualifications) are not explicitly present in the provided document.
Acceptance Criteria and Reported Device Performance
The document states that "Actual device performance as tested internally conforms to the system performance specifications." However, specific numerical acceptance criteria or performance metrics (e.g., accuracy, precision, sensitivity, specificity) for target diameter or IMT measurements are not provided in the supplied text. The 510(k) summary focuses more on the equivalence to a predicate device and the general intent of the software to aid human experts.
Given the information, a table of acceptance criteria and reported device performance cannot be fully constructed with quantitative values from the provided text. The general "acceptance criteria" can be inferred as "satisfies the design intent" and "conforms to system performance specifications."
| Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|
| Satisfies the design intent | Meets the design intent |
| Conforms to system performance specifications | Conforms to system performance specifications |
| Aids the human expert in obtaining quantitative information | Aids the human expert |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The provided document does not specify the sample size for the test set.
- Data provenance (country of origin, retrospective/prospective): This information is not provided in the text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not provided in the text. The document repeatedly refers to the human expert for inspection and editing, but does not detail how ground truth for a test set was established.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This detail is not provided in the text.
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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:
- A formal MRMC comparative effectiveness study, specifically measuring the improvement of human readers with AI assistance versus without, is not explicitly mentioned or detailed. The document states that the software "aids the human expert to obtain quantitative information" and that the "human expert analyst is responsible for inspection and - if needed - editing of the identified vessel wall borders prior to their approval." This implies a human-in-the-loop workflow, but not a study designed to quantify the effect size of improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies a human-in-the-loop system where the human expert is responsible for final approval and editing. It does not explicitly state whether a standalone (algorithm only) performance assessment was conducted for the purpose of regulatory substantial equivalence. The language "aids the human expert" and "human expert analyst is responsible for inspection and - if needed - editing" strongly suggests the device is not intended for standalone use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not explicitly stated in the provided text. Given the clinical context of ultrasound image analysis, it is most likely based on expert measurements, possibly through manual tracing or consensus readings, but this is not confirmed.
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The sample size for the training set:
- The sample size for the training set is not provided in the text. The document mentions internal testing and validation but doesn't detail the data used for training.
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How the ground truth for the training set was established:
- This information is not provided in the text.
Summary of what is known from the provided text:
- Device Purpose: "Vascular Tools 5" is software for computer-aided assessment of vascular diameter and intima-media thickness (IMT) from ultrasound images. It includes "Brachial Analyzer 5" and "Carotid Analyzer 5" modules.
- Intended Use: To determine brachial artery diameter, carotid artery diameter, and carotid artery IMT. It "aids the human expert to obtain quantitative information."
- Human-in-the-loop: The human expert is responsible for inspecting and editing the identified vessel wall borders before approval.
- Validation: "Test and validation results support the conclusion that the actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications."
- Missing Details: The document lacks specific quantitative acceptance criteria, test set size, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, and details on standalone or comparative effectiveness studies. These are likely present in the "Detailed assessment... in Appendix D," which is not included.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).