(116 days)
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.
| Feature/Criterion | Reported Device Performance/Compliance |
|---|---|
| Intended Use/Indications | "The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg... for positioning of the pediatric patient in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems." |
| Compatibility | Compatible with specified GE 1.5T and 3.0T Head, Neck, and Spine Coils and Invivo 1.5T and 3.0T 8-Channel High Resolution Brain Array Coils. |
| Fundamental Technology | "The Pediatric Positioner Pad Set employs the same fundamental technology as the predicate devices." (Implies it functions similarly to previously cleared devices). |
| Safety and Effectiveness | "GE Healthcare considers the Pediatric Positioner Pad Set to be as safe, as effective, and performance is substantially equivalent to the predicate devices." (This is the overarching conclusion of the submission, derived from compliance with regulations and the clinical study). |
| Voluntary Standards | "Complies with voluntary standards." (Specific standards are not listed in the provided text). |
| Quality System Regulations | "Designed and developed under the Quality System Regulations of 21 CFR 820 and ISO 13485." |
| Quality Assurance Measures | Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification). These are internal process controls to ensure the device is built to specifications and is safe. |
| Clinical Efficacy/Utility | A clinical study on pediatric subjects was conducted "to support substantial equivalence and to ensure the user needs are met." The clinical images obtained were included in DICOM format. (This implies that the device successfully aided in patient positioning, allowing for Diagnostic Quality images, but specific metrics like image quality scores are not provided in this summary.) |
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.
§ 892.1830 Radiologic patient cradle.
(a)
Identification. A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.