(29 days)
The ONI MSK Extreme™ MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
The MSK Extreme™ MR Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.
This is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) would.
Based on the provided text, the device is the MSK Extreme™ MRI Scanner. The document focuses on demonstrating substantial equivalence to existing MRI scanners (OrthOne Extremity MRI Scanner (K001773), Philips Medical Systems Achieva 1.5T (K052013), and MAGNETOM Systems with Software syngo MR 2006A (1.5T Symphony version) (K052164)).
Here's an analysis of the requested information based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics for the MSK Extreme™ MRI Scanner in a comparison table. The submission relies on demonstrating substantial equivalence.
Instead, it states:
"In addition to being technologically equivalent to the predicate devices, the MSK Extreme™ MR Scanner has been subjected to performance testing and it has been determined that the MSK Extreme™ MR Scanner is suitable for its intended use."
This indicates that general performance testing was conducted to ensure suitability, rather than meeting pre-defined quantitative acceptance criteria against a clinical benchmark for a new claim.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any information regarding a specific test set sample size or data provenance (country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary focused on substantial equivalence for an imaging device of this nature, where the primary "test" is often focused on engineering and image quality compared to the predicate, rather than an outcome-based clinical trial.
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)
The document does not provide any information about experts used to establish ground truth or their qualifications. The "ground truth" for an MRI scanner's performance in a 510(k) context would likely be the image quality and diagnostic capabilities being comparable to the predicate devices, which is generally assessed by qualified personnel within the manufacturing and regulatory review process, but not typically detailed as an "expert panel" for ground truth establishment for a test set in the submission summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for a test set.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an MRI scanner, a hardware device for image acquisition, not an AI-powered diagnostic tool. Therefore, a study assessing human reader improvement with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not mention any standalone algorithm performance testing. This device is an MRI scanner, not an algorithm, so this type of testing is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the document does not detail a specific "ground truth" methodology in the context of a clinical study with patients and outcomes. For an MRI scanner in a 510(k), the "ground truth" for demonstrating equivalence largely revolves around technical specifications, phantom imaging, and potentially comparing images from the new device to those from predicate devices to ensure similar diagnostic quality.
8. The sample size for the training set
The document does not mention any training set or its sample size. This is an MRI hardware device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how its ground truth was established.
Summary of what the document DOES state:
- Acceptance Criteria/Performance (Implicit): The device (MSK Extreme™ MRI Scanner) was subjected to performance testing and determined to be "suitable for its intended use" and "technologically equivalent" to predicate devices (OrthOne Extremity MRI Scanner (K001773), Philips Medical Systems Achieva 1.5T (K052013), and MAGNETOM Systems with Software syngo MR 2006A (1.5T Symphony version) (K052164)). The primary "acceptance criterion" for a 510(k) is often simply demonstrating substantial equivalence to a legally marketed predicate device.
- Study Type: This is a 510(k) Premarket Notification, which primarily involves demonstrating substantial equivalence (safety and effectiveness) to predicate devices through a comparison of technological characteristics and performance data. It is not typically a full-scale clinical trial with detailed metrics as would be found in a PMA.
- Non-clinical Data: The device is manufactured using similar processes and equivalent materials as its predicate, and its indications for use have not changed. This non-clinical data supports the claim of substantial equivalence.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.