(113 days)
The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head, spine and cardiac that can be interpreted by a trained physician.
The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
The 1.5T 8ch Flex Suite is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.
The provided text describes a 510(k) premarket notification for a medical device, the "8ch Flex Suite," an MRI receive-only coil. However, the document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test and training sets, expert involvement, and ground truth establishment cannot be extracted from this document, as it pertains to a different type of device clearance (an MRI coil, not an AI diagnostic algorithm) and a different regulatory pathway (substantial equivalence, not a de novo or PMA requiring detailed performance studies against defined criteria for an algorithm).
The document mentions "Clinical images evaluation testing for the proposed device was evaluated by connected to compatible MRI system," and that "Based on above testing, the proposed 8ch Flex Suite was found to have a safety and effectiveness profile that is similar to the predicate device." This suggests image quality and clinical utility were assessed, but the specifics of how this was done, what metrics were used, or any quantitative "acceptance criteria" for image performance are not provided. The comparison focuses on technical specifications and intended use matching a predicate device.
To directly answer your request based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not applicable/provided. The document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and intended use, not on specific performance metrics for an AI/ML algorithm against predefined acceptance criteria.
- 2. Sample sized used for the test set and the data provenance: Not applicable/provided. There is no mention of a "test set" in the context of an AI/ML algorithm's performance. The clinical evaluation refers to the performance of the coil itself.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. No ground truth establishment for an AI/ML algorithm is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/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: Not applicable/provided. This device is an MRI coil, not an AI assistance tool for human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/provided. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/provided.
- 8. The sample size for the training set: Not applicable/provided. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable/provided.
In summary, the provided document is a 510(k) summary for an MRI coil, not an AI/ML diagnostic device. Therefore, the information requested about AI/ML acceptance criteria and performance studies is not contained within this text.
§ 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.