(209 days)
Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, and scaphocephalic- shaped heads.
The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.
The provided text describes a 510(k) submission for a medical device called "MyCRO Band," a cranial orthosis used for infants with positional plagiocephaly. However, the document does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested in the prompt.
Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (STARband®) based on similar indications for use, intended use, basic principles of operation, and basic design, along with non-clinical testing. It mentions "Scanner Evaluation utilized a worst-case challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility" and "Verification testing included dimensional analysis, fit assessment, and mechanical testing of test samples," but it does not provide:
- A table of specific acceptance criteria and reported device performance values related to clinical outcomes or direct head shape correction metrics.
- Sample sizes for a clinical test set (as the described tests are non-clinical).
- Data provenance (country of origin, retrospective/prospective).
- Information on experts establishing ground truth or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance (as this is a physical orthosis, not an AI/algorithm-based device).
- Type of ground truth used related to clinical efficacy.
- Training set sample size or ground truth establishment for a training set (again, not an AI/algorithm device).
The "Summary of Testing" section lists:
- Biological evaluation per ISO 10993-1:2018
- Cytotoxicity testing per ISO 10993-5:2009
- Irritation and Sensitization testing per ISO 10993-10:2010
- Scanner evaluation, including repeatability/reproducibility study
- Verification testing
While these tests "successfully met the predetermined acceptance criteria," the specific criteria and the detailed results demonstrating the device's efficacy in correcting cranial deformities (beyond dimensional accuracy of the scanner or fit of the orthosis) are not provided in this 510(k) summary. These are typically covered in a more detailed study report that is part of the full 510(k) submission but not included in this high-level summary.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and proven device performance based solely on the provided text. The text focuses on the engineering and biocompatibility aspects for demonstrating substantial equivalence rather than a detailed clinical performance study as would be seen for an AI/algorithm device or a device with novel mechanisms of action requiring extensive clinical validation.
§ 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)).