(60 days)
The Static Cranioplasty Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to 18 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.
The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened areas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician.
The orthosis is custom designed for each patient from a mold of the infant's head. The mold is modified and prepared for fabrication by the treating practitioner using mathematical analyses and plaster modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, an inner lining of hypoallergenic foam, a strap for securing the orthosis, and a polymer hinge and guiding system to maintain proper alignment of the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
Executive Summary
The device in question is the "Static Cranioplasty Orthosis" (also referred to as "Cranial Molding Orthosis"), intended to treat abnormally shaped craniums in infants aged three to 18 months with nonsynostotic positional plagiocephaly. The submission indicates that no specific quantitative acceptance criteria or detailed study protocols were provided within the summary. Instead, the effectiveness was established by asserting its performance was "significantly effective" and "almost uniformly" to a predicate device based on a "pilot study" and "statistical analyses."
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics (e.g., specific percentage reduction in cranial asymmetry measurements). | - "Significantly effective in correcting abnormal head shape" |
| - "No evidence of relapse following treatment" | |
| - "Significantly effective in realigning the asymmetrical craniums of infants" | |
| - "No abnormal reactions or relapses were recorded during the study or during long term follow-ups" | |
| - Performed "almost uniformly to the predicate device" in respective trials. | |
| Safety | - Materials established safe through standard biocompatibility assessments. |
| - Materials "not expected to adversely affect the infants" | |
| - Materials "not reported to cause skin irritation or any toxic effects." | |
| - Product designed to "avoid improper migration or harmful levels of pressure." | |
| - Interior of device "smooth and poses no significant threat." |
Study Details
The provided document describes the study in very general terms, lacking specific quantitative data, methodologies, or detailed results typically found in full clinical trials.
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Sample Size and Data Provenance:
- Test Set Sample Size: Not specified. The document mentions "clinical trials" and a "pilot study" but does not provide the number of subjects included in these studies.
- Data Provenance: Not specified (e.g., country of origin, specific institutions). The studies are described as "conducted using the Static Cranioplasty Orthosis," implying they are specific to this device, but details are absent. It's noted they were "identical to those conducted using the predicate device." It's reasonable to infer a retrospective approach given the limited details provided about the study setup.
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Number and Qualifications of Experts for Ground Truth: Not specified. There is no mention of experts establishing ground truth or their qualifications.
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Adjudication Method: Not specified.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed or reported. This device is a physical orthosis, not an AI or imaging device where MRMC studies are typically applied.
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Standalone Performance Study (Algorithm Only): Not applicable. This is a physical medical device, not an algorithm.
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Type of Ground Truth Used: Not explicitly stated. Given the nature of plagiocephaly treatment, the "ground truth" would likely be based on clinical assessments and measurements of cranial symmetry and shape, probably verified by medical practitioners. However, the exact methods are not detailed.
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Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "device" itself is a physical orthosis, custom-designed for each patient.
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How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device. The custom design for each patient involves mathematical analyses and plaster modification techniques by the treating practitioner based on a mold of the infant's head.
§ 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)).