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The STARband® 3D™ is 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, brachycephalic and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium to improve cranial symmetry and/or shape.

The STARband® 3D™ redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® 3D™ provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband® 3D™ directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

This document is an FDA 510(k) clearance letter and summary for a medical device called STARband 3D. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific studies conducted to prove acceptance criteria for a new, independent device.

Therefore, the information required to accurately answer the prompt (acceptance criteria, specific study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text. The document states that:

• "Nonclinical performance testing performed for the predicate device and reference device remains applicable as there was no design change to the device."
• "Validation was conducted to evaluate one potential risk identified during design control activities and no impact on safety or effectiveness was identified."
• "These tests are referenced in the submission." (But the submission itself is not provided).

Without the actual submission that details the non-clinical performance tests and their results, I cannot provide the specific information requested in the prompt regarding the device's acceptance criteria and the study that proves it meets them.

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