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The STARlight is intended for medical purposes for use on infants from three 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 in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARlight 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 modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion. The proposed modification is the addition of the STARlight PRO design, which is an amalgamation of the STARlight Side Opening design and the STARlight Cap design. The STARlight Side Opening design, STARlight Bi-Valve design and the STARlight Cap design are all made of a plastic shell of 5/32" -- 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design uses a 1/4" to 3/8" clear Surlyn shell for patients with a head circumference over 18" (over approximately 1 year of age) and a 5/32" to 1/4" clear Surlyn shell for all patients with a head circumference less than 18". The STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design. The STARlight Cap design is made of the above plastic and contains no straps. The STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bivalve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The provided text is a 510(k) Summary for a device modification, specifically the STARlight® Cranial Orthosis. It describes the device, its intended use, and compares the modified device to its predicate. However, it does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The FDA letter (Sections 5-7) confirms that the device is substantially equivalent to legally marketed predicate devices, but this is a regulatory determination based on comparison of technological characteristics and indications for use, not on a new study demonstrating performance against specific acceptance criteria.

The submission is for a "Special 510(k)" for a device modification, which means that the sponsor is asserting that the changes do not raise new questions of safety or effectiveness and can be considered substantially equivalent to the previously cleared device without extensive new performance data. The core principle of operation remains the same ("applies pressure to the prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape"). The main change is an increase in material thickness for the STARlight PRO design, intended for older, larger-headed infants, to provide increased rigidity. The submission argues that this change is minor and does not alter the fundamental mechanism or clinical effect.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment because this data is not present in the provided document. The document describes a medical device, its intended use, and modifications, but does not include clinical efficacy studies or performance metrics with predefined acceptance criteria.

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