Search Results

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 3.0T system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The Pediatric Head-Spine Coil is an 8-channel phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Four elements are in the head area and four elements reside in the back portion of the device. It includes two parts (upper part and the bottom). The upper part can be easily taken down from the bottom. So the Pediatric Head-Spine Coil could be operated expediently. The enclosure is 3.5mm thick PC, which is UL 94V_0 rated and can withstand highest peak RF voltage up to 4200V and drop and impact.

The provided text is a 510(k) summary for a Pediatric Head-Spine Coil (Model: 5000012701). This device is a passive component of an MRI system (a receive-only coil) and its effectiveness is determined by its ability to produce diagnostic images. The information provided heavily focuses on regulatory compliance and comparison to a predicate device, rather than detailed performance study results that would typically involve acceptance criteria for diagnostic accuracy metrics (like sensitivity, specificity, or AUC) as one might expect for an AI/CADe device.

Based on the provided text, the device's acceptance criteria are primarily related to its safety and ability to function equivalently to a predicate device in producing diagnostic images.

Here's an attempt to structure the information based on your request, highlighting where specific details (typical for AI/CADe studies) are not available in this submission:

Acceptance Criteria and Device Performance Study for Pediatric Head-Spine Coil (Model: 5000012701)

This 510(k) submission for the Pediatric Head-Spine Coil focuses on demonstrating substantial equivalence to a legally marketed predicate device (K081322) and compliance with relevant safety and performance standards, rather than a clinical efficacy study with specific diagnostic performance metrics typically seen with AI/CADe devices.

The "acceptance criteria" can be inferred from the regulatory requirements for showing substantial equivalence and the "study" is the overall demonstration of this equivalence and compliance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For this type of device, "performance tests" typically refer to engineering benchmarks (e.g., Signal-to-Noise Ratio, uniformity, geometric distortion) conducted in a lab or phantom study, ensuring the coil functions as designed and produces images suitable for diagnosis without explicitly measuring clinical outcomes or diagnostic accuracy in human subjects.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable in the context of clinical images or patient data for diagnostic accuracy. The "tests" mentioned are likely performance and safety tests on the device itself (e.g., phantom imaging, electrical safety, biocompatibility, mechanical durability).
• Data Provenance: Not applicable for clinical image data. The provenance of the device's components and manufacturing is "Shanghai Chenguang Medical Technologies Co., Ltd." in P.R.C.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This submission does not describe a study involving expert readers establishing ground truth for diagnostic accuracy, as it's a device for image acquisition, not interpretation or diagnosis. The images are "interpreted by a trained physician" but this is part of the intended use, not a study methodology cited here.

4. Adjudication method for the test set

• Not applicable. No external adjudication method is mentioned for diagnostic accuracy, as no clinical performance study involving human interpretation of images for ground truth was conducted or described in this summary.

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

• No, an MRMC comparative effectiveness study was not done. This device is an MRI coil, not an AI or CADe system designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, a standalone performance study was not done. This device is an MRI coil, a hardware component for image acquisition, and does not have an "algorithm-only" performance to evaluate.

7. The type of ground truth used

• The concept of "ground truth" as typically defined for diagnostic accuracy studies (e.g., pathology, expert consensus) is not directly applicable to this device's regulatory submission. The "ground truth" for the device's technical performance would be engineering specifications and standards against which its functionality and safety were measured. For example, "performance tests" would verify if the coil produces images with expected signal integrity, resolution, and uniformity, implicitly considered "true" to its design specifications.

8. The sample size for the training set

• Not applicable. This submission relates to an MRI coil (hardware), not a machine learning or AI algorithm, so there is no training set in that context.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set mentioned for an AI/ML algorithm, this question is not relevant to the provided submission.

Ask a specific question about this device