(90 days)
The INTERA-SENSATION Family Release 1-series magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis
The INTERA-SENSATION Release 1 family is the successor of the current (Gyroscan) INTERA family Release 10-series. It consists of various configurations with magnetic field strengths (1.0T, 1.5T & 3.0T) and different optional gradient types. The INTERA-SENSATION Release 1 family is based on the same platform with the same functionalities as its predecessor. The main differences with the its predecessors (/ predicate devices) are: - new appearance (covers) . - . data acquisition system supports 1,4,6,8 and 16 channels and is prepared for 32 channels - Advanced shimming and SUPER QUASAR gradient. . - Added new functionality: Examcards, MobiFlex, MobiView, O-flow, Real . Time Bold Imaging, Re-scan, and CareTrak - Enhancements related to the use of up to date computer technology such as ● larger electronic data storage (memory) capacity.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Philips Medical Systems INTERA-SENSATION family of Magnetic Resonance Diagnostic Devices (MRDD). This document describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
However, the core of your request involves acceptance criteria and a study that proves the device meets those criteria. The provided text does not contain specific acceptance criteria or an efficacy study as typically understood for AI/CADe devices, because this submission is for a general MRI machine, not an AI or CADe system.
The submission focuses on establishing substantial equivalence to a predicate device (Gyroscan INTERA family release 10-series). The argument for safety and effectiveness is based on the new device being a direct successor with the "same safety and effectiveness as its predecessor," with differences primarily in updated hardware, increased channel support, advanced shimming, and new functionalities like Examcards, MobiFlex, etc. These are technical improvements to an existing device, not a new diagnostic algorithm requiring an efficacy study with clinical endpoints.
Therefore, many of the requested sections (sample size, ground truth, expert qualifications, MRMC study, standalone performance) are not applicable or detailed in this type of submission.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where your requested information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device does not induce new risks compared to predicate. | "The INTERA SENSATION Release 1-series family does not induce any other risks than already indicated for the predicate devices." |
| Effectiveness: Device has the same effectiveness as the predicate. | "It has the same safety and effectiveness as its predecessor." |
| Substantial Equivalence: Device performs equivalently to the predicate. | "It is the opinion of Philips Medical Systems that the Philips INTERA SENSATION Release 1-series family is substantially equivalent to its predecessor." |
| Image Production: Produces transverse, sagittal, coronal, and oblique cross-sectional images based on 'H metabolites. | Device produces these image types to display internal bodily structures. (Inferred to be equivalent to predicate.) |
| Diagnostic Assistance: Images, when interpreted by a trained physician, yield information assisting diagnosis. | Device provides information assisting in diagnosis. (Inferred to be equivalent to predicate.) |
| Compliance: Meets NEMA voluntary standards, FDA MR Diagnostic Device Guidance, UL and IEC 601 safety standards. | Explicitly stated that these standards are used. The submission implies that the device meets these during its development and testing. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. This submission is for an MRI system, not an AI/CADe algorithm that would typically undergo a clinical test set evaluation. The "study" here is a technical review and comparison to a predicate device, not a clinical trial with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. No test set with ground truth established by experts is described in this submission. The "ground truth" for this type of device is its ability to physically generate MR images, which is assessed through engineering and design verification.
4. Adjudication method for the test set
- Not applicable / Not provided. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. No MRMC study is mentioned. This type of study is relevant for assessing the impact of AI on human reader performance, which isn't the scope of this submission for an MRI machine itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. There isn't a "standalone algorithm" in the context of this MRI system submission that would have its performance reported. The device is the imaging system.
7. The type of ground truth used
- Not applicable / Not explicitly defined. For an MRI machine, the "ground truth" for its performance isn't a clinical diagnosis like in an AI/CADe system. Instead, it's about the physical fidelity and quality of the images it produces, its adherence to safety standards, and its equivalence to established predicate devices in terms of image quality and diagnostic utility. This is assessed through engineering tests, phantom studies, and comparison to the predicate's known performance.
8. The sample size for the training set
- Not applicable / Not provided. There is no "training set" in the context of an MRI machine itself. Training sets are relevant for AI algorithms that learn from data.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there's no training set, there's no ground truth establishment for it.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or justification proving the device meets its acceptance criteria is primarily an argument for substantial equivalence to an already cleared predicate device (Gyroscan INTERA family release 10-series).
The key points of this justification are:
- Device as Successor: The INTERA-SENSATION Release 1 family is presented as the successor to the predicate, built on the "same platform with the same functionalities."
- Safety and Effectiveness Claim: Philips Medical Systems explicitly states its opinion that the new device "does not induce any other risks than already indicated for the predicate devices" and "has the same safety and effectiveness as its predecessor."
- Technical Differences: The differences highlighted are primarily technological updates and enhancements (e.g., new appearance, increased channel support, advanced shimming, new software functionalities like Examcards, MobiFlex). These are presented as improvements that maintain or enhance the existing proven safety and effectiveness, rather than introducing new diagnostic capabilities that would require extensive clinical validation.
- Compliance with Standards: The submission states that NEMA voluntary standards, FDA MR Diagnostic Device Guidance, UL, and IEC 601 safety standards are used. This implies that the device's design and testing process adheres to these recognized standards for MRI equipment.
In essence, the "proof" is based on the engineering design, adherence to regulatory standards for medical devices, and a comparative analysis demonstrating that the updated device functions equivalently and safely as its legally marketed predecessor, fulfilling the requirements for a 510(k) submission based on 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.