(89 days)
The Precision Prosthetics and Orthotics, Inc. orthotic molding 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 non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
The Precision Prosthetic and Orthotics, Inc. orthotic molding helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a foam-lined, lightweight, bivalve rigid plastic helmet with the anterior section overlapping the posterior section. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other open areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the open areas.
The provided text is a 510(k) Summary for a cranial orthosis (helmet) and the accompanying FDA clearance letter. It describes the device, its intended use, and states that information was provided on biocompatibility and safety/effectiveness. However, it does not contain details about specific acceptance criteria or a study designed to prove the device meets those criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or comparative effectiveness as this information is not present in the provided text.
Here is what can be inferred from the document:
- Device Type: Cranial Orthosis (Orthotic Molding Helmet)
- Intended Use: To apply passive pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
- Predicate Device: Dynamic Orthotic Cranioplasty - DOC Band® (K964992)
- Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a legally marketed predicate device. This process typically involves demonstrating that the new device is as safe and effective as the predicate, but the specific studies and acceptance criteria used for this demonstration are not detailed in this summary.
To answer your request, a different type of document, such as a full clinical study report or a detailed submission summary, would be needed to extract the specific information about acceptance criteria and study methodologies.
§ 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)).