(89 days)
Intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
The BeckerBand™ is a thermoplastic helmet prepared with USP Class VI materials, consisting of a polypropylene or polypropylene-polyethylene copolymer outer shell. To this shell is thermobonded a medium density polyethylene foam inner lining. The device is fabricated by taking a plaster-of-paris impression of the infants head. This impression is filled with a plaster to create a positive mold of the skull. The deformity is corrected to the desired configuration by building the mold up in selected areas with molding material. This corrected model serves as a template for preparation of the Becker Band orthosis. The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions.
The provided text is a 510(k) summary for the BeckerBand™ Cranial Remolding Orthosis. It states that "The BeckerBand" complies with the Class II special controls established for this device in the classification process to provide assurance of safety and effectiveness." However, it does not include any information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, or standalone performance data).
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on similar materials, technology, and compliance with general controls and special controls. The "Clinical Discussion and Literature" section only states "A comprehensive review of the literature was provided," without presenting specific study findings or data.
Therefore, I cannot complete the table or answer the subsequent questions based on the information provided in the input document. The document explicitly states "Performance standards: None, Special Controls required," further suggesting that the submission relied on demonstrating equivalence and adherence to general and special controls rather than a specific performance study against predefined 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)).