(36 days)
The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 1.5T magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
The Model 0100040201-AP Body Cardiac ArrayCoil1.5T 8ch consists of two parts, bottom part with a cable and a base plate. Bottom part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of body and cardiac of a pediatric body in magnetic resonance imaging systems. Bottom part forms an 8channel phased array, receive-only coil, used for obtaining diagnostic images of the cardiac -body area of a pediatric patient in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
The provided text describes a 510(k) premarket notification for a medical device: the Shanghai Chenguang Medical Technologies Body Cardiac ArrayCoil1.5T 8ch (Model 0100040201-AP). This device is a receive-only coil used for obtaining diagnostic images of pediatric body and cardiac regions in magnetic resonance imaging systems.
However, the provided text does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods. The document is a 510(k) summary for a diagnostic device that is substantially equivalent to predicate devices, and the information provided is focused on regulatory clearance rather than a detailed performance study.
Therefore, for aspects related to acceptance criteria, device performance, study methodology, and ground truth, the answer is that this information is not available in the provided FDA 510(k) document.
Here’s a breakdown of what can be extracted based on the request, with explicit notes about missing information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. This type of document (510(k) summary) focuses on substantial equivalence to a predicate device rather than detailed performance against specific acceptance criteria. Typically, performance would be assessed through image quality metrics (e.g., signal-to-noise ratio, uniformity, spatial resolution) and compared to the predicate. | Not specified in the provided document. The document states its intended use is to obtain diagnostic images that, when interpreted by a trained physician, yield information that may assist in diagnosis. It implies the performance is sufficient for this purpose by virtue of its substantial equivalence to predicate devices, but no quantitative performance metrics are provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. (The 510(k) process often relies on existing data from predicate devices or internal testing, but no details are given).
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as no specific clinical study data is presented to establish ground truth.
- Qualifications of Experts: Not applicable. The document mentions "trained physician" for interpreting images, but not in the context of ground truth establishment for a performance study.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable, as no specific clinical study data requiring adjudication is presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is a hardware component (MRI coil), not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This device is a hardware component. Standalone performance typically refers to the performance of an AI algorithm without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable, as no specific performance study requiring ground truth is detailed in this regulatory submission. For an MRI coil, performance is often evaluated through physical and imaging metrics (e.g., SNR, uniformity, image resolution), rather than a diagnostic accuracy relative to a "ground truth" diagnosis.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This is a hardware device (MRI coil), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable, as this is a hardware device.
§ 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.