(92 days)
ACHIEVA family consists of diagnostic devices that produce cross-sectional 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 family is the successor of the predicate Intera Achieva family release 1-series. The design of ACHIEVA family is based on the same software platform and hardware technology as its predicate device. All MR system parts of the ACHIEVA family have the same appearance. The ACHIEVA family is extended with enhancements and new functionalities for contrast enhanced MRA techniques and faster scanning techniques. Furthermore it is extended with SENSE Body wrap coil RF-coil and extension of multi-nuclei spectroscopy with 3T coils.
This document is a 510(k) summary for the Philips Medical Systems ACHIEVA family of Magnetic Resonance Diagnostic Devices (MRDD). It details the device's general information, predicate device, indications for use, and a statement of substantial equivalence.
Based on the provided text, here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document primarily focuses on substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria. The core assertion is that "The ACHIEVA family does not induce any other risks than already indicated for its predicate device with the same safety and effectiveness." This implies that the acceptance criteria are met by virtue of being equivalent to the already cleared predicate device.
Therefore, a table of specific numerical acceptance criteria and reported device performance from this document cannot be directly constructed as those details are not provided. The "performance" reported is essentially that it is substantially equivalent to the predicate.
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 details on a specific test set, sample size, or data provenance as it relies on substantial equivalence. There is no mention of a particular study with a test set.
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):
This information is not available in the document as no specific test set or study requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the document as no specific test set or study requiring adjudication 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:
This document describes a Magnetic Resonance Diagnostic Device (MRDD), which is an imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This document describes an imaging device, not an algorithm, so a standalone algorithm-only performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the document as no specific study involving ground truth establishment is described. The basis for clearance is substantial equivalence to a predicate device.
8. The sample size for the training set:
This information is not available in the document as no machine learning algorithm development with a training set is described.
9. How the ground truth for the training set was established:
This information is not available in the document as no machine learning algorithm development with a training set is described.
§ 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.