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The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems for positioning of the pediatric patient.

The Pediatric Positioner Pad Set is a positioning device for pediatric patients used with brain, spine, and neurovascular surface coils in Magnetic Resonance Imaging. It is comprised of foam coated in Polyscan. The Pediatric Positioner Pad Set is comprised of seven components: the Base Pad, the Main Pad, the Child Head Pad, the Infant Head Pad, the two Pad Side Supports, and the Head Strap. The Base Pad rests on the MR System table. The Main Pad is then placed on top of the Base Pad. The patient is positioned on top of the Main Pad. The two Pad Side Supports are secured on either side of the patient via Velcro. Lastly, either the Child Head Pad or Infant Head Pad is used with the Head Strap to hold the patient's head in place. There are two sizes for the head pad to accommodate different patient sizes.

The provided text describes a 510(k) premarket notification for a medical device called the "Pediatric Positioner Pad Set." This device is a passive positioning aid for pediatric patients during Magnetic Resonance Imaging (MRI).

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of performance metrics (e.g., specific accuracy, sensitivity, or specificity values) for the Pediatric Positioner Pad Set. This is because the device is a passive positioning aid and not an active diagnostic or therapeutic device that produces measurable outputs requiring such criteria.

Instead, the document states the device's compliance with qualitative requirements related to its intended use and safety.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document states that a "clinical study on pediatric subjects" was conducted. However, it does not specify the sample size (number of subjects) used in this clinical study (which serves as the "test set" for performance evaluation).
• Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a GE Healthcare submission to the FDA, it is highly probable the data was collected in the United States. The study was prospective, as it was a "clinical study on pediatric subjects" specifically conducted to support this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention "experts" being used to establish a formal "ground truth" in the traditional sense (e.g., for diagnostic accuracy). Since this is a positioning device, the "ground truth" would likely be the successful positioning of the patient and the acquisition of diagnostic quality MRI images.

The primary "evaluation" would have been performed by the medical staff (MR technologists, radiologists) involved in the clinical study, who would have assessed the device's ability to facilitate effective patient positioning for image acquisition. Their qualifications are not specified but would implicitly be relevant medical professionals.

4. Adjudication Method for the Test Set

No specific adjudication method (like 2+1, 3+1 consensus) is described, as the evaluation likely revolved around the usability and effectiveness of patient positioning rather than a diagnostic decision requiring such adjudication.

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

An MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human readers are assisted by AI. The Pediatric Positioner Pad Set is a passive physical device, not an AI or software-based diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance evaluation was not done. Again, this concept applies to algorithms or software. The Pediatric Positioner Pad Set is a physical device that functions with human interaction (positioning the patient) to achieve its intended purpose.

7. The Type of Ground Truth Used

The "ground truth" for this device would be the successful, safe, and stable positioning of pediatric patients for MRI scans, leading to the acquisition of diagnostic quality images. It is not a pathology diagnosis or an outcome measure in the typical sense. The "ground truth" is inherently tied to the practical utility in a clinical setting.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is not an AI or machine learning algorithm. Its design and development followed standard engineering and quality system processes, as indicated by the "Quality Assurance Measures" (Risk Analysis, Requirements Reviews, Design Reviews, etc.).

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the device's design and development comes from user needs, regulatory requirements, risk analysis, and engineering specifications.

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The intended use of the Noras OR head coil 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Used in the 1.5T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

The OR Head Coil 1.5T is an 8-channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. Each channel is tuned to the Larmor frequency of the 1H spin in a magnetic field of 1.5T, 63.6 MHz. Each coil is connected to the MAGNETOM system by a separate cable. Use of the OR Head Coil 1.5T requires the Siemens OR Head Holder.

This submission is for a medical device (OR Head Coil 1.5T) and not a diagnostic algorithm. Therefore, many of the requested criteria, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample size for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth definitions, are not applicable in the context of device clearance for an MRI head coil.

The regulatory approval for this device (K060758) is based on substantial equivalence to a predicate device, not on meeting specific quantifiable performance metrics for an AI algorithm.

However, I can extract the relevant information regarding the device itself and its safety and effectiveness considerations from the provided text.

Here's a breakdown of the relevant information:

Acceptance Criteria and Device Performance (in the context of a medical device submission)

Study Details (as inferable from the document, though not a typical "study" for an AI algorithm)

1. Sample Size used for the test set and the data provenance: Not applicable. This is a device clearance for hardware. NEMA tests involve standardized phantoms and equipment, not patient data in the sense of a clinical trial for an algorithm. The "test set" here refers to the device itself being tested for compliance with engineering standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for device hardware testing. Ground truth (e.g., accurate measurements) for NEMA standards compliance is established by the test procedures themselves.
3. Adjudication method for the test set: Not applicable. Compliance with NEMA and IEC standards is determined by achieving defined measured values.
4. 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-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (head coil).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the NEMA and IEC standards, the "ground truth" is adherence to predefined technical specifications and safety limits for electromagnetic fields, image uniformity, signal-to-noise ratio, etc. These are engineering and physics-based measurements.
7. The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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