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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. These devices are 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-, 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 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 superior 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, specifically, the NetVirta SmartSoc™ System distributed by Orthomerica Products, Inc. This system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade digital camera with it's a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source.

The provided document describes the FDA 510(k) summary for the STARband and STARlight Cranial Orthosis, specifically focusing on the addition of the NetVirta SmartSoc™ System for 3-dimensional shape capture. The document outlines non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for the SmartSoc System's performance in terms of cranial shape capture. Instead, it states that the conclusion of the studies was that the "Proposed device is substantially equivalent to predicate device." The studies were designed to compare the SmartSoc System against a cast and the predicate device (presumably the previously approved imaging devices for the STARband/STARlight).

However, the document does describe the types of tests performed and their general conclusions:

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

• Sample Size for R&R and Accuracy Studies: The document states for R&R, it "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." For the Accuracy Study, it "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." Crucially, the exact number of these "uniform shapes" or "representative cranial shapes" (i.e., the n for the test set) is not specified. This is a significant omission from the provided summary.
• Data Provenance: The studies appear to be in vitro or phantom-based studies ("uniform shapes," "representative cranial shape") rather than involving human subjects. Therefore, concerns about country of origin, retrospective/prospective, are not directly applicable in the way they would be for patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable or not specified. Ground truth appears to have been established by "known dimensions" of the uniform/representative shapes and comparison against physical casts. There's no mention of human expert involvement in defining the "truth" for these technical accuracy studies.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for the technical studies on shape capture involved predefined, known physical dimensions and comparisons to physical casts, not subjective human assessment requiring adjudication.

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

• MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies focus on the technical accuracy and consistency of the 3D capture system itself, not on how human readers/practitioners improve with or without AI assistance in diagnosis or treatment planning.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the studies described (Repeatability and Reproducibility, Cranial Shape Capture Accuracy) assess the performance of the SmartSoc System itself (algorithm and hardware) in capturing shapes accurately and consistently, independent of human interpretation of the captured data for clinical decision-making. The "device" in this context is the SmartSoc system which captures the 3D shape, and its output (the 3D image) is then used to manufacture the orthosis. The studies verify the fidelity of this capture process.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For the Repeatability and Reproducibility (R&R) Testing Analysis and Cranial Shape Capture Accuracy Study, the ground truth was based on known physical dimensions of "uniform shapes" or "representative cranial shapes" with "predefined shape with known dimensions." The system's output was also compared to "cast and predicate device." This suggests a physical phantom/model comparison with known measurements.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. This document is a 510(k) summary for a medical device (cranial orthosis) with a new imaging modality (SmartSoc System). It focuses on validation testing of the new modality. It does not provide details of any internal training data used by the SmartSoc system's algorithms, if applicable. The SmartSoc system uses "a customized non-repetitive printed pattern" on a flexible fabric sock; its internal algorithms for 3D reconstruction would have been developed and trained by NetVirta, but those details are not in this FDA summary.

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth: Not specified in this document for the reasons mentioned in point 8.

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