(81 days)
The LLUMC Cranial Remolding Helmet is a cranial orthosis that is intended for use on 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 device is intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. It is indicated for prescription use.
The LLUMC Cranial Remolding Helmet is a cranial orthosis used to treat children 3-18 months of age for moderate to severe non-synostotic plagiocephaly, brachycephally, and scaphocephally. The LLUMC Cranial Remolding Helmet is fabricated from a cast impression of the infant's cranium, taken by a certified orthotist (CO). The negative cast impression is converted by the CO into a positive impression and rectified into the desired corrected shape. The helmet is then formed over the corrected positive mold by a registered orthotic technician (RTO). A 1/4" polyethylene form (Volara) is used as an interface (liner) material, and 3/16" sheet of polyethylene plastic is used as the outer shell. The helmet is then trimmed by the RTQ, as necessary to not obstruct the infant's vision, hearing, ability to breathe or restrict movement of the head and neck. Ventilation holes are added to reduce heat retention. The CO fits the Cranial Remolding Helmet to the infant. The Cranial Remolding Helmet provides a gentle pressure over the prominent areas of the cranium in an effort to slow the growth in these areas. Voids are provided in an effort to encourage growth over the flat areas and reduce deformity. The infant is then evaluated monthly by the CO to monitor growth and insure that a precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the helmet.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the LLUMC Cranial Remolding Helmet, which focuses on:
- Applicant information and device identification.
- Description of the device and its intended use.
- Comparison to a predicate device (Clarren Helmet) to establish substantial equivalence based on technological characteristics.
- Biocompatibility information.
- FDA's letter confirming substantial equivalence and allowing the device to be marketed.
- Statement of Indications for Use and Contraindications.
There is no mention of:
- Numerical acceptance criteria for device performance.
- A study specifically designed to demonstrate that the device meets such criteria.
- Sample sizes for test sets, data provenance, expert numbers and qualifications, or adjudication methods for ground truth establishment.
- Details about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Details regarding the training set for the device (as this is a physical medical device, not an AI/software product).
The substantial equivalence determination is based on the LLUMC Cranial Remolding Helmet having the same technological characteristics (custom-made, soft foam lining, rigid thermoplastic shell, method of operation to direct cranial growth) and intended use as the predicate device, the Clarren Helmet (K003035). The document implies that the device is considered effective for its intended use because its fundamental design and mechanism of action are consistent with a device already on the market and cleared by the FDA.
§ 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)).