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The STARband 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 in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use 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-, brachycephalicand scaphocephalic-shaped heads.

The STARband redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a 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 using 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 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 STARband 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 consists of a 5/32" outer copolymer shell with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). There is a top opening and a side opening. The strap across the side opening is 1 ½" Dacron and Velcro and is attached to the STARband with a chafe and loop. A ½" pelite polyethylene foam gap block fills any gap in the side opening. The proposed device modification is the addition of a new shape capture method, specifically the scanGogh-II" by Vorum Research, Inc. This scanner uses one laser and one camera to capture shape data.

Acceptance Criteria and Device Performance Study for STARband® Cranial Orthosis

This document describes the acceptance criteria and the study that demonstrates the STARband® Cranial Orthosis, specifically with the integration of the scanGogh-II scanner, meets these criteria.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified STARband® Cranial Orthosis with the scanGogh-II scanner were established through a comparison to the predicate device (STARband cleared in K082950) and a traditional plaster cast method. The study aimed to demonstrate that the scanGogh-II, as a new head shape capture method, performed at least as well as, or superior to, the existing methods for capturing cranial shape parameters.

Table of Acceptance Criteria and Reported Device Performance (scanGogh-II vs. Cast Method):

"Pass (Superior)" in the reported device performance indicates that the scanGogh-II accuracy performed superior to the Cast method.

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

• Test Set Sample Size: The document states that the testing "utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." However, a specific numerical sample size for the test set (i.e., the number of cranial shapes used) is not explicitly provided in the summary.
• Data Provenance: The study appears to be an ex-vivo or in-vitro study using "uniform shapes with known dimensions." It does not involve human subjects or retrospective/prospective patient data.

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

The document does not mention using human experts to establish the ground truth for the test set. The ground truth was based on "uniform shapes with known dimensions," implying pre-engineered or precisely measured physical models.

4. Adjudication Method for the Test Set

The concept of an adjudication method by experts is not applicable here, as the ground truth was based on known dimensions of physical models rather than subjective interpretation of medical data. The comparison was quantitative, against predefined measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study conducted. This study focused on the accuracy of a shape capture device (scanGogh-II) compared to existing methods (cast and predicate device), not on the improvement of human readers with AI assistance. The device is a tool to create orthoses, not an AI diagnostic aid requiring human interpretation of output.

6. Standalone Performance Study

Yes, a standalone performance study was done for the scanGogh-II scanner. The "Cranial Shape Capture Accuracy Study" directly evaluates the scanGogh-II by comparing its output (captured dimensions) to the known dimensions of representative cranial shapes. The scanGogh-II's accuracy, reproducibility, and repeatability were assessed independent of human intervention in the interpretation of the scan data itself.

7. Type of Ground Truth Used

The ground truth used was based on known dimensions of "representative cranial shapes." These are likely engineered models or phantoms with precisely defined measurements for various cranial parameters (e.g., A-P length, M-L width, various radii, squareness, and flatness). This is a metrological ground truth.

8. Sample Size for the Training Set

The document does not provide information regarding a training set sample size. The modification involves a new shape capture method (scanner), not a machine learning algorithm that typically requires a large training dataset. The evaluation is for the accuracy and consistency of the measurement device itself.

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

As no training set is discussed or implied for the scanGogh-II's function as a shape capture device, the method for establishing its ground truth is not applicable in this context. The study focuses on evaluating the scanner's performance against predefined physical standards, not on training an AI model.

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