(84 days)
The STARlight is available by prescription only and intended for use in infants from three to 18 months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagicephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild manta wer prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape.
The STARlight is a cranial remolding orthosis used to treat abnormal head shape (clinically referred to as positional or deformational plagiocephaly) in infants aged three to 18 months. The orthosis provides total contact over the protruding areas of deformity and leaves room for growth over those areas of the infant's head that were flattened during deformation. The STARlight cranial remolding orthosis is available only when prescribed by a physician.
The orthosis is custom made for each patient from a mold or three-dimensional scan of the infant's head initially prepared by the treating clinician. The mold or electronic file is then sent to Orthomerica where it is used to create the orthosis. Each orthosis is comprised of a plastic shell, either in full form with no openings, side-opening, or with bi-valved design and sliding/overlap closure system. The treating clinician modifies and adjusts for a precise fit, and monitors its use throughout the treatment program to ensure that no severe adverse reactions occur.
This document describes the STARlight Cranial Remolding Orthosis and summarizes its safety and effectiveness.
Here's an analysis based on the provided text, focusing on the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness: Improvement in cranial symmetry and/or shape. | "Results were recorded at the end of the treatment period and again at 12, 18 and 24 month follow-ups. The study documented complete or near complete correction of asymmetry for a wide variety of head shapes." |
| Effectiveness: Correction of abnormal head shape without relapse. | "Researchers studying the effects of treatment with cranial orthoses on infants have concluded that the devices are effective in correcting abnormal head shape. without evidence of relapse follow treatment." |
| Effectiveness: Improvement of surgical results (in severe cases). | "In addition, treatment with cranial remolding orthoses is reported to improve the results of surgery in severe cases to such a degree that an ordinarily necessary additional surgical treatment can be avoided." |
| Safety: Biocompatibility; no adverse skin reactions or toxic harms. | "The biocompatibility assessments reveal that the orthosis is not expected to adversely affect infants under intended conditions of wear. Specifically, the materials used in the orthosis are not reported to cause skin irritation or any toxic harms." |
| Safety: Designed to avoid improper slippage or harmful pressure. | "In addition, the product is designed to avoid improper slippage or harmful levels of pressure." |
| Safety: Smooth internal surface and edges to prevent agitation or abrasion. | "The internal surface and edges of the orthosis are smooth and does not pose threats of agitation or abrasion." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The most comprehensive assessment mentioned "monitored the treatment of more than 750 infants over a span of nearly ten years." This appears to refer to the primary effectiveness study.
- Data Provenance: The document does not explicitly state the country of origin. Given the submission to the FDA, it's likely primarily US-based or at least applicable to the US context. The study is described retrospectively ("monitored the treatment of... over a span of nearly ten years") but the exact design (prospective vs. retrospective data collection within that ten-year period) is not fully clarified for the "750 infants" study. The general description "Researchers studying the effects of treatment with cranial orthoses on infants have concluded..." suggests a synthesis of existing research rather than a single prospective trial for the STARlight device specifically.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide details on the number or qualifications of experts used to establish ground truth for the effectiveness studies. The assessment relies on the "conclusion of researchers" and the "documentation" from the study rather than a formal expert panel for ground truth assessment of individual cases.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method for the test set or for how "complete or near complete correction of asymmetry" was definitively determined. It implies clinical assessment by treating clinicians/researchers.
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
- Not applicable. This document describes a medical device (cranial orthosis), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance effect size are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its physical properties and clinical application by healthcare professionals.
7. The Type of Ground Truth Used
- The ground truth for effectiveness appears to be clinical assessment and outcomes data (improvement in cranial symmetry, correction of abnormal head shape, avoidance of additional surgery, lack of relapse). This is based on the "results were recorded" and "concluded that the devices are effective" statements.
- For safety, the ground truth is established through biocompatibility assessments (laboratory tests) and the absence of reported adverse events like skin irritation or toxic harms, and proper design to prevent pressure/abrasion issues.
8. The Sample Size for the Training Set
- Not applicable. This device is custom-made for each patient based on an individual mold or 3D scan. There isn't a "training set" in the sense of machine learning. Its design and manufacturing processes are likely informed by clinical experience and general biomechanical principles, but not a formal training dataset for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no "training set" in the machine learning context, there's no ground truth established for one. The efficacy of the design principle (total contact over protruding areas, voids over flattened areas) is based on established medical understanding of cranial reshaping and clinical experience, supported by the studies mentioned.
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).