(37 days)
The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 1.5T system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
The Model 0100140201 Pediatric Head and Spine Array Coil1.5T 8ch consists is a single unit with eight coils. Four coils are in the head area and four coils reside in the back portion of the device. This forms a 8-channel phased array, receive-only coil, used for obtaining diagnostic images of head and spine of a pediatric body in magnetic resonance imaging systems. Combination of back part and head part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of the head and spine in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
The provided text is a 510(k) summary for a medical device (Pediatric Head and Spine Array Coil), which focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way a clinical trial or performance study for a diagnostic AI algorithm would.
Instead, the submission for this type of device (an MRI coil) primarily focuses on:
- Device Description: What the device is and how it works.
- Intended Use: The clinical purpose of the device.
- Substantial Equivalence: Comparing the device to a legally marketed predicate device to show it is as safe and effective. This often means demonstrating similar technical characteristics, materials, and performance specifications (e.g., signal-to-noise ratio, image uniformity), rather than clinical diagnostic accuracy.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of 510(k) submission for an MRI coil.
However, I can extract the relevant information from the document as best as possible, focusing on what is available. It's important to note that the "device performance" in this context refers to the coil's technical imaging capabilities rather than diagnostic accuracy.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a clinical performance study. For a device like an MRI coil, performance is typically evaluated through technical specifications and comparison to a predicate device. The 510(k) summary asserts "substantial equivalence" based on the device's design and intended use being similar to the predicate.
The closest we can infer for "device performance" is its ability to produce diagnostic images.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Inferred/Stated in 510(k) process) |
|---|---|
| Safety: Device is as safe as the predicate device. | The 510(k) process determined substantial equivalence to a legally marketed predicate device (PHS-63 Pediatric Head Spine Coil, K003655), implying similar safety characteristics. |
| Effectiveness: Device is as effective as the predicate device in its intended use. | The 510(k) process determined substantial equivalence. The device "is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems." It is described as a "8-channel phased array, receive-only coil, used for obtaining diagnostic images of head and spine of a pediatric body in magnetic resonance imaging systems," which "when interpreted by a trained physician, yielding information that may assist in diagnosis." This mirrors the intended function of typical MRI coils. |
| Interoperability: Device is compatible with specified MRI systems. | "This coil is designed to be used in a Philips Achieva MRI 1.5T system." |
| Technical Characteristics: Similar physical and electrical characteristics to predicate (e.g., number of channels, type of array, material if relevant). | "The Model 0100140201 Pediatric Head and Spine Array Coil1.5T 8ch consists is a single unit with eight coils. Four coils are in the head area and four coils reside in the back portion of the device. This forms a 8-channel phased array, receive-only coil..." This is compared to the predicate's (PHS-63 Pediatric Head Spine Coil, K003655) technical specifications for substantial equivalence. |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets the (inferred) acceptance criteria is the 510(k) premarket notification process itself, demonstrating substantial equivalence to the predicate device K003655 (PHS-63 Pediatric Head Spine Coil, manufactured by MRI Devices Corporation). This typically involves providing technical data and comparisons rather than clinical outcome studies of diagnostic accuracy in the way an AI algorithm would.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for an MRI coil, not a diagnostic algorithm that processes images. There is no "test set" of patient data in the context of diagnostic performance. Performance is evaluated through engineering and technical testing, and comparison to the predicate device's specifications.
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)
- Not Applicable. See point 2. Ground truth for diagnostic performance is not relevant for an MRI coil's substantial equivalence submission. The images produced by the coil "when interpreted by a trained physician, yielding information that may assist in diagnosis." The interpretation is by experts, but the coil itself is not being evaluated for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2 and 3.
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. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm. The device is a "receive-only coil" that produces images for interpretation by a "trained physician."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. See point 2 and 3.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.