(7 days)
ACHIEVA 1.5T & INTERA 1.5T family consists of diagnostic devices that produce crosssectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician yield information that may assist in diagnosis.
The ACHIEVA 1.5T & INTERA 1.5T family is the successor of the predicate ACHIEVA family release 1-series. The design of ACHIEVA 1.5T & INTERA 1.5T family is based on the same software platform and hardware technology as its predicate device. All MR system parts of the ACHIEVA 1.5T & INTERA 1.5T family have the same appearance. The new gradient configurations are more powerful than their previous versions available on the Intera 1.5T and Achieva 1.5T systems. Especially the slewrate of these systems is improved. This improved slewrate allows for shorter echo times (TE), Echo Spacing (ES) and repetition times (TR).
The provided document is a 510(k) summary for the Philips ACHIEVA 1.5T & INTERA 1.5T family of Magnetic Resonance Diagnostic Devices (MRDD). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable (N/A) because they are typically part of a de novo submission or a premarket approval (PMA) application, not a 510(k) for substantial equivalence based on technology upgrades.
Here's a breakdown of the information that can be extracted or that is N/A based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Substantial Equivalence to Predicate Device (K043147) | Equivalent design, software platform, and hardware technology. No new risks. | Based on the same software platform and hardware technology as its predicate device. All MR system parts have the same appearance. New gradient configurations are more powerful, allowing for shorter echo times (TE), Echo Spacing (ES), and repetition times (TR). | The core "acceptance criteria" here is substantial equivalence to the predicate, which the submission asserts is met due to similar fundamental design and technology, with improvements in gradient configurations. |
| Safety and Effectiveness | No other risks beyond those indicated for the predicate device. | Does not induce any other risks than already indicated for its predicate device with the same safety and effectiveness. | This is a declarative statement of safety and effectiveness being equivalent to the predicate. |
2. Sample size used for the test set and the data provenance:
- N/A. This submission leverages the substantial equivalence pathway, not a clinical trial with a distinct test set to evaluate performance against specific criteria. The comparison is primarily against the predicate device's existing clearance and safety profile.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. As no new clinical study with a test set for diagnostic accuracy was conducted for this 510(k), there wasn't a process described for establishing clinical ground truth for a test set. The "ground truth" implicitly relies on the established safety and effectiveness of the existing predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical test set requiring adjudication was used as part of this substantial equivalence submission.
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:
- N/A. This device (Magnetic Resonance Diagnostic Device) is a foundational imaging modality, not an AI-assisted diagnostic tool. No MRMC study or AI-related effectiveness study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is an imaging hardware system, not an algorithm, and thus standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the performance and safety record of the predicate device (ACHIEVA family release 1-series, K043147). The submission asserts that the new device shares the same fundamental technology and does not introduce new safety or effectiveness concerns.
8. The sample size for the training set:
- N/A. This is a hardware and software upgrade to an existing MRI system. The concept of a "training set" as understood in machine learning/AI is not applicable here. The development would involve engineering design, testing, and validation against technical specifications rather than a data-driven training process in the AI sense.
9. How the ground truth for the training set was established:
- N/A. As explained above, the concept of a "training set" with established ground truth is not relevant to this type of device submission.
§ 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.