(89 days)
The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).
The device is a soltware package to be used on the same software as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Spar 20, Mod 40, or higher. The images used to provide these 3D reconstructions can be captured by any CT or MR system and transferred to Advantage Windows workstation by DICOM or Ethernet.
The provided documents do not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, this is a 510(k) submission for the "Advantage Windows Volume Rendering Option" which focuses on demonstrating substantial equivalence to already marketed devices. The document highlights the device's intended use, description, and states its substantial equivalence in design, construction, principle of operation, and features to the predicate devices.
Therefore, many of the requested details about acceptance criteria, detailed performance studies, sample sizes, and ground truth establishment are not present in this type of regulatory submission. The goal of this submission is not to prove specific performance metrics against pre-defined acceptance criteria, but rather to show that the new device is as safe and effective as a legally marketed predicate device.
Here's a breakdown of what can be extracted or inferred from the provided information, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | No adverse affects on health reported. Package itself will not have any adverse effects. |
| Effectiveness | Enhances current Advantage Windows 3D package by providing depth and position of overlapping structures. |
| Intended Use | Provides fast, easy volume visualization of 3D structures from CT/MR. Dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning. Reconstructs and displays translucent 3D models for diagnosis confidence or planning surgical treatment. |
| Substantial Equivalence | Substantially equivalent to Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859) in design, construction, principle of operation, and features. |
Missing:
- Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing speed targets, image quality ratings) are not provided.
- Clearly defined numerical acceptance criteria for any performance aspect are not stated.
2. Sample size used for the test set and the data provenance
Missing: The document does not describe a formal "test set" or specific study involving patient data to evaluate the performance of this device. The assessment is based on substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing: As there's no described performance study or test set, there is no information on experts establishing ground truth.
4. Adjudication method for the test set
Missing: No test set or adjudication method is described.
5. 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
Missing: No MRMC study is mentioned. This device is a volume rendering tool, not an AI-assisted diagnostic tool in the modern sense that would typically involve a "human readers improve with AI vs without AI" comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing: No standalone performance study based on specific metrics is described. The device's function is to reconstruct and display models for operator interpretation, inherently involving a human-in-the-loop.
7. The type of ground truth used
Missing: No specific ground truth methodology is described as there isn't a performance study evaluating diagnostic accuracy.
8. The sample size for the training set
Missing: This device predates the widespread use of large-scale machine learning and deep learning models that typically require large "training sets." The device's functionality appears to be based on established algorithms for volume rendering, not a learned model from a training set in the contemporary sense.
9. How the ground truth for the training set was established
Missing: Not applicable, as there's no indication of a training set for a machine learning model.
Summary of the Study (or lack thereof, in the typical sense):
The provided information is a 510(k) summary for an accessory device (software) for CT/MR systems. The "study" described herein is the process of demonstrating substantial equivalence to predicate devices already on the market. This involves:
- Identification of Predicate Devices: Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859).
- Comparison of Device Features and Principles of Operation: The submitter argues that the new Volume Rendering Option "enhances the current Advantage Windows 3D package by providing showing depth and position of overlapping structures" but is "substantially equivalent... in design, construction, principle of operation, and features."
- Assessment of Safety: The document states that "The package itself will not have any adverse affects on health."
- Intended Use Statement: Clearly defines how the device is to be used.
The FDA's letter (K972399) confirms that they have reviewed the submission and determined that the device is substantially equivalent to predicate devices for the stated indications for use. This regulatory pathway does not typically require extensive clinical performance studies or a detailed breakdown of acceptance criteria and performance data as would be seen for devices seeking a PMA or those involving novel AI algorithms.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.