(11 days)
The Children's Hospital cranial helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
The Children's Hospital cranial helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a lightweight, semi-rigid plastic helmet with a foam lining. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other recessed areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.
The provided document K013458 for the "Cranial Helmet" (cranial orthosis) does not contain a study that proves the device meets specific acceptance criteria in the way described in the request. This document is a 510(k) summary submitted to the FDA for market clearance, making a claim of substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing the points you requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Hypothetical, as not explicitly stated in 510(k)) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility of skin-contacting materials | Information was provided on the biocompatibility of the skin-contacting materials. (No specific metrics or pass/fail criteria reported in this summary). |
| Effectiveness: Improvement in cranial symmetry and/or shape | Information was provided on the safety and effectiveness of the helmet. (No specific metrics, studies, or quantitative results showing "improvement" are detailed in this summary). |
| Custom-made fit and function | Each helmet is assembled individually, custom-made using a negative impression and plaster model to fit snugly in some areas and be recessed in others for reshaping. |
Explanation: The 510(k) summary for K013458 states, "Information was provided on the biocompatibility of the skin-contacting materials and on the safety and effectiveness of the helmet." However, it does not provide any specific acceptance criteria (e.g., a numerical threshold for improvement, pass/fail rates for specific tests) nor does it report detailed performance data or a study demonstrating how these criteria were met. The summary indicates that the device's safety and effectiveness were affirmed, likely through a combination of predicate device equivalence and internal testing/documentation that is not fully detailed in this public summary.
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary does not mention any specific sample size for a test set or the provenance of any data used for validation studies. The "Summary of Studies" section is very brief and only states that information was provided on biocompatibility, safety, and effectiveness. It does not describe a clinical study or a test set of patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. There is no mention of a test set, ground truth establishment, or experts involved in such a process.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the 510(k) summary. Since no specific test set or study results are detailed, there is no mention of an adjudication method.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical cranial orthosis, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study with human readers would be relevant. The 510(k) pertains to a medical device's physical and functional properties, not an AI algorithm's performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical product (cranial helmet), not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The 510(k) summary does not detail any specific ground truth type as it does not describe a study involving data classification or diagnostic accuracy. The implicit "ground truth" for a cranial orthosis would be the clinical assessment of cranial symmetry improvement over time, but no such data or its establishment method is presented in this document. Substantial equivalence claims often rely on the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
This information is not provided in the 510(k) summary. Given that it's a physical medical device and not an AI/software product, there wouldn't typically be a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided as there is no mention of a training set or its ground truth establishment, due to the nature of the device (physical cranial orthosis vs. AI/software).
Conclusion:
The provided 510(k) summary for the Children's Hospital Cranial Helmet focuses on describing the device, its intended use, and its technological characteristics. It makes a general statement about information being provided on biocompatibility, safety, and effectiveness. However, it does not include a detailed study report that specifies acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert involvement in the manner typically expected for algorithmic or diagnostic device studies. The clearance is based on substantial equivalence to a predicate device (Gillette Children's Specialty Healthcare - CranioCap™), implying that the safety and effectiveness of the new device are comparable to that of the already marketed predicate.
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).