(262 days)
The Cranial Solutions Orthosis is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly,including infants with plagiocephalic, brachycephalic, and scaphocephalic shaped heads. The CSO is intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve cranial symmetry and or shape.
The CSO is a custom made medical device intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve symmetry and or shape. The device is of thermoplastic construct. A semi-rigid outer shell of Orthopedic grade copolymer polypropylene thermobonded to a medium durometer polyethylene foam inner liner(Volara). The formula for the outer shell is [ch(ch3)ch2-] 90% polypropylene and 10% polyethylene. By design the CSO is a dynamic orthotic device.
The provided document is a 510(k) summary for the Cranial Solutions Orthosis (CSO), a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically seen for performance claims or AI/software analysis.
The document primarily focuses on establishing substantial equivalence to a predicate device (the Dynamic Orthotic Cranioplasty (DOC) device) based on similar indications for use, design, materials, and treatment principles. It describes the device and its intended use, but does not present a clinical study with performance metrics and acceptance criteria for the CSO device itself.
Therefore, I cannot populate the table or answer the questions as no such data is present in the provided text.
Here's why and what kind of information is present instead:
- Acceptance Criteria & Reported Performance: These are not defined in the context of device performance metrics. The document instead claims equivalence in intended use and design to the predicate device.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance: These concepts are relevant to studies evaluating the diagnostic or predictive performance of a device, often seen in algorithms or imaging systems. This document describes a physical orthosis, not a software or AI product.
- Training Set Information: Not applicable as this is a physical device, not an AI model.
What the document does include:
- Device Description: The CSO is a custom-made thermoplastic orthosis intended to apply gentle pressure and provide realignment space for infants with non-synostotic positional plagiocephaly.
- Predicate Device: Dynamic Orthotic Cranioplasty (DOC) device.
- Indications for Use: Infants aged three to eighteen months with moderate to severe non-synostotic positional plagiocephaly (including plagiocephalic, brachycephalic, and scaphocephalic head shapes).
- Contraindications: Infants with craniosynostosis or hydrocephalus.
- Design Similarities to Predicate: Both devices have a single lateral opening, a generous top opening for airflow, are lightweight, adjustable for growth, easy to apply/remove, and constructed from thermoplastic with a semi-rigid outer shell and soft inner lining.
- Mechanism of Action: Dynamic design applying mild pressure to correct abnormal growth and improve cranial symmetry.
- Clinical Tool: Cranial Solutions Anthropometric measurement form used after obtaining a plaster impression to involve parents and monitor progress.
- Safety Considerations: Warnings regarding monitoring head circumference, skin checks by caregivers, and precautions about treating torticollis, device fit/function, and structural integrity.
- Adverse Events: Skin irritation is possible but can be avoided by following cleaning and usage instructions.
In summary, the provided text is a regulatory submission for a physical medical device based on substantial equivalence, not a study evaluating its performance against specific acceptance criteria.
§ 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)).