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510(k) Data Aggregation
(75 days)
The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.
The main features in the Optical Tracking Unit include: 1) infrared digitizer hardware; 2) specialized tools and tracking devices for procedures; 3) software that guides the imaging plane based on information from the digitizer; 4) software utilities that allow for slice reformatting of 3D image sets and 5) MRGP graphical overlays for planning and intraoperative use.
This guidance mechanism shortens the time needed to find the correct imaging plane, and is useful in cases that require a difficult trajectory (i.e. double oblique imaging planes).
The provided text is a summary of a 510(k) premarket notification for the "MRGP Optical Tracking Unit," an accessory for Magnetic Resonance Imaging (MRI) systems. The document establishes substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving device performance against those criteria in the way a clinical trial would for a diagnostic AI device.
Therefore, many of the requested elements (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training) are not applicable or not provided in this specific type of regulatory submission. This document focuses on demonstrating that the new device is as safe and effective as previously cleared devices.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a dedicated performance study with specific metrics like sensitivity, specificity, or accuracy that would typically be found for a diagnostic AI device. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various technical parameters and indications for use. The "reported device performance" is implicitly that it functions equivalently to the predicate devices.
| Parameter | Acceptance Criteria (Predicate Equivalent) | Reported Device Performance (MRGP Optical Tracking Unit) |
|---|---|---|
| System Compatibility | 0.23T Outlook, 0.23T Outlook Proview | Same (compatible with 0.23T Outlook, 0.23T Outlook Proview) |
| Software | Standard Outlook Software | Special MRGP Software for the Outlook |
| Imaging Plane Selection | Manual | Optically Guided (This is a distinguishing feature, but shown to achieve the same outcome as manual guidance in the predicate, i.e., guiding diagnostic/therapeutic interventional procedures) |
| Sequence type | 2D/3D Gradient echo, FSE, Single-shot FSE | Same (2D/3D Gradient echo, FSE, Single-shot FSE) |
| Sequence capabilities | Dynamic imaging with auto start and keyhole imaging capabilities. Typical reconstruction of 200 ms per image. | Same (Dynamic imaging with auto start and keyhole imaging capabilities. Typical reconstruction of 200 ms per image.) |
| Sequence resolution | FOV- 4 to 40 cm; Slice thickness- 2D: 1-100mm (0.1mm steps), 3D: 0.4-100mm (0.1mm steps); Matrix- up to 512 | Same (FOV- 4 to 40 cm; Slice thickness- 2D: 1-100mm (0.1mm steps), 3D: 0.4-100mm (0.1mm steps); Matrix- up to 512) |
| Type of Digitizer | Infrared signals emitted from the Position Sensor Assembly (PSA) are reflected off reflective markers mounted on the tool. The reflected signal is detected by the PSA with two optical detectors. | Same (Infrared signals emitted from the Position Sensor Assembly (PSA) are reflected off reflective markers mounted on the tool. The reflected signal is detected by the PSA with two optical detectors.) |
| Max. Digitizer Rate | 30 Hz for one or two tools; for three tools, the rate is 30 Hz for one of the tools and 15 Hz for the other two. | Same (30 Hz for one or two tools; for three tools, the rate is 30 Hz for one of the tools and 15 Hz for the other two.) |
| Active Digitizer Volume | Silo shape, with 1 meter diameter and 1 meter length. | Same (Silo shape, with 1 meter diameter and 1 meter length.) |
| Type of Sterilization | Tool bodies are steam sterilized and the reflective spheres are sterilized with ETO. | Same (Tool bodies are steam sterilized and the reflective spheres are sterilized with ETO.) |
| Material Composition of tool bodies | Aluminum, titanium or stainless steel | Polyethermide and Polyphenylsulfone (This is a differentiating parameter, but is likely considered equivalent in terms of safety and function for its intended use, as implied by the substantial equivalence determination) |
| Indications for Use | Support and guide diagnostic interventional procedures, such as needle biopsies and drainages. | Designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages. (Expands on "therapeutic" in addition to "diagnostic" compared to one predicate, but still considered substantially equivalent to the overall combined functionality of the predicates). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) submission based on substantial equivalence to existing predicate devices, not a performance study that would typically involve a "test set" of patient data for evaluating an algorithm's performance.
3. 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)
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set 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
Not applicable. No MRMC study is described. The device is a physical/software accessory for interventional MRI, not an AI diagnostic aid that assists human readers in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an optical tracking unit designed to "support and guide" procedures, inherently requiring human interaction and interpretation. It is not an autonomous algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth is mentioned in the context of device performance evaluation as it would be for a diagnostic algorithm. Substantial equivalence is based on comparing device specifications and intended use.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/machine learning device being evaluated in that manner.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for a training set is mentioned.
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