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The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, 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 devices are also indicated for infants from 3 to 18 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 STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image 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 STARband and STARlight provide 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 and 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 STARband and STARlight product families as it was released in K141842 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are 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 is made of 1/4" to 3/8" clear Surlyn. 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 STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap (1½" for STARband Side Opening and 1" for STARlight Side Opening) 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 Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is the addition of a new 3-dimensional shape capture method, specifically, the Vorum Spectra™ 3D Scanner uses a high quality LED structured light projector and a single camera to detect the shape of the surface captured. This scanner utilizes LED light which is a non-coherent (i.e. non-laser) light source.

This document describes the acceptance criteria and study proving the device meets these criteria for the STARband® and STARlight® Cranial Orthosis, specifically focusing on the addition of the Vorum Spectra™ 3D Scanner as a new method for capturing infant head shape.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• R&R Analysis & Cranial Shape Capture Accuracy Study: The document mentions "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" for the R&R analysis, and "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" for the accuracy study. Specific numeric sample sizes are not provided in the given text.
• Data Provenance: The studies were conducted by Orthomerica Products, Inc., likely within their internal testing processes. The country of origin and whether the data was retrospective or prospective is not explicitly stated for these performance studies. However, as it's for a 510(k) submission, it would typically be prospective testing conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Not applicable for these engineering performance studies. The ground truth for the R&R analysis and Cranial Shape Capture Accuracy Study was established using "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions." This implies the "ground truth" was a precisely manufactured physical standard with measurable dimensions. No human expert interpretation was required.

4. Adjudication Method for the Test Set:

• Not applicable. As the ground truth was based on physical standards with known dimensions, human adjudication was not part of these engineering performance tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted diagnostic device, but rather a medical device (cranial orthosis) with a new 3D scanning method for fabrication. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, effectively. The performance studies (R&R and Cranial Shape Capture Accuracy) evaluated the Spectra 3D Scanner itself (an "algorithm only" component in the context of data capture) against known physical standards and compared its results to existing methods (casting and predicate devices). The scanner's output (3D head shape data) is then used in a manufacturing process, but the studies focused on the performance of the scanner as a standalone data capture tool.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• For the Repeatability and Reproducibility (R&R) Analysis and Cranial Shape Capture Accuracy Study, the ground truth was based on known dimensions of uniform shapes and a predefined cranial shape. This is a form of physical/reference standard.
• For Material Biocompatibility Testing, the ground truth was established by standardized laboratory test procedures (e.g., scoring criteria for sensitization and irritation, cell reactivity grades for cytotoxicity).

8. The Sample Size for the Training Set:

• Not explicitly stated in the provided text. As this is a 510(k) submission for a physical device with a new input method (scanner) rather than a complex AI model, the concept of a separate "training set" for the device itself (cranial orthosis) is likely not applicable in the same way it would be for a machine learning algorithm. The scanner itself would have internal calibration and testing procedures during its development, but these are not detailed here.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as a separate "training set" for the device's clinical performance or the scanner's core functionality is not detailed as per the response to point 8. The "ground truth" for the performance studies shown here (R&R, Accuracy) was established through precisely manufactured physical standards.

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