(42 days)
PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional 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 PANORAMA 1.0T provides the same functionalities as its predicate device. It is a magnetic resonance diagnostic device with a vertical field. It uses a super conducting actively shielded magnet with a static field of 1.0 Tesla and a dockable wheeled patient table (couch).
The provided document is a 510(k) summary for the Philips PANORAMA 1.0T Magnetic Resonance Diagnostic Device. It claims substantial equivalence to a predicate device (INTERA ACHIEVA, K031815) and does not contain detailed performance studies with acceptance criteria as one would expect for a novel AI device.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.
Here's a breakdown of the available information and why other fields cannot be completed:
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Acceptance Criteria and Reported Device Performance: This device is a Magnetic Resonance Diagnostic Device (MRDD). For such devices, acceptance criteria are typically related to fundamental imaging performance aspects like signal-to-noise ratio (SNR), spatial resolution, image uniformity, geometric accuracy, and safety parameters (e.g., specific absorption rate (SAR), magnetic field homogeneity). However, the document does not provide specific quantitative acceptance criteria or reported device performance metrics for the PANORAMA 1.0T. It simply states that the new device "provides the same functionalities as its predicate device" and "has the same safety and effectiveness as its predicate device."
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Study Details: Since this is a submission for a substantially equivalent device, clinical performance studies in the way you'd describe for a novel AI device (e.g., test set, expert readers, ground truth) are typically not presented in this summary document. The substantial equivalence argument relies on the inherent similarity of the new device to the predicate rather than new performance data.
Therefore, the table below will largely reflect what is not present or not applicable based on the provided text, along with a note that this is a predicate-based submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Description | Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) | Explanation/Notes |
|---|---|---|---|
| Overall Performance/Equivalence | "Same safety and effectiveness as its predicate device" and "provides the same functionalities as its predicate device" | Not explicitly quantified in this document. | The core "acceptance" for this 510(k) is the demonstration of substantial equivalence to a legally marketed predicate device (cylindrical INTERA ACHIEVA, K031815). This means it is expected to perform comparably, but specific quantitative performance criteria for image quality metrics (like SNR, resolution, contrast) are not presented in this summary. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. The submission is based on substantial equivalence to a predicate device, not a new clinical performance study.
- Data Provenance: Not applicable/Not provided.
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 new clinical performance study with expert ground truth was conducted or reported in this summary.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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:
- No. This is a conventional MRI device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a conventional MRI device.
7. The type of ground truth used:
- Not applicable/Not provided. The submission relies on the established safety and effectiveness of the predicate device.
8. The sample size for the training set:
- Not applicable/Not provided. This is a conventional MRI device, not an AI model requiring a training set in the typical sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of the Study (as described in the document for the 510(k) submission):
The "study" or justification for the PANORAMA 1.0T's market clearance is a demonstration of substantial equivalence to an existing legally marketed device, the Philips INTERA ACHIEVA (K031815).
- Study Design: This is not a clinical trial or performance study in the traditional sense for a novel device. Instead, it's a regulatory comparison.
- Purpose: To demonstrate that the PANORAMA 1.0T, a Magnetic Resonance Diagnostic Device, is as safe and effective as its predicate device.
- Methodology: The submission highlights that the PANORAMA 1.0T "provides the same functionalities as its predicate device" and "has the same safety and effectiveness." It is a magnetic resonance diagnostic device with a vertical field, similar to its predicate which used a cylindrical field (the document states it's based on the "same platform" as the cylindrical INTERA ACHIEVA). The primary justification is the inherent similarity in design, intended use, and fundamental operating principles.
- Results: The FDA reviewed the 510(k) submission and determined that the device is "substantially equivalent" for the stated indications for use, thereby permitting its marketing. This implies that the FDA accepted the manufacturer's assertion that the performance characteristics, safety, and effectiveness would be comparable to the predicate device, without requiring new, specific quantitative performance data to be included in this summary.
§ 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.