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Infants. 3 - 18 months of age, with abnormally shaped craniums with no outstanding cranial abnormalities that have a RX from a physician who has assessed the child to rule out craniosynostosis.

The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattenedareas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician.

The orthosis is custom designed for each patient from a cast of the infant's head or a scan using the STARscanner from Orthomerica . The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathematical analyses and plaster modification techniques. The orthosis is then fabricated under the direction of the same practitioner. Each orthosis is composed of an outer shell of thermoformable plastic, 5-6 layers of hypoallergenic polyethylene foam and a strap for securing the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.

The provided text describes a 510(k) submission for the Boston Band Cranial Remolding Orthosis. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study designed to prove the device meets specific acceptance criteria with reported performance metrics in the way a clinical trial for a novel AI or diagnostic device would.

Therefore, many of the requested details (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable or present in this type of regulatory document.

However, I can extract the information related to the device's effectiveness as established by referencing a clinical trial and comparing it to a predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria or reported device performance in a dedicated table format. Instead, it claims substantial equivalence to a predicate device and references a clinical trial to establish "effectiveness." The "acceptance criteria" here are implicitly meeting the standard of effectiveness and safety demonstrated by the predicate and supported by existing clinical literature.

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

• Sample Size for Test Set: Not explicitly stated in this document for the Boston Band. The effectiveness claim relies on a clinical trial referenced for cranial orthoses in general, not specifically for the Boston Band.
• Data Provenance: The document references a clinical trial: "Ottoto: Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s." The provenance of that study's data (country of origin, retrospective/prospective) is not provided in this 510(k) submission.

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

This information is not provided because the document references an existing clinical trial for cranial orthoses to establish effectiveness. There is no "test set" in the context of validating a new algorithm, or a process described for establishing ground truth from experts for this specific 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. The document relies on a referenced clinical trial's methodology, not a separate adjudication process described here for a specific test set.

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 is a medical device (cranial orthosis), not an AI or diagnostic imaging device that involves "human readers" or "AI assistance."

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness claim is based on the outcomes reported in the referenced clinical trial ("Ottoto: Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s"). This would typically involve clinical outcome data (e.g., changes in cranial measurements, resolution of deformities) rather than expert consensus, pathology, or other types of ground truth used for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" in this context.

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

Not applicable.

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The Static Cranioplasty Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to 18 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.

The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened areas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician.

The orthosis is custom designed for each patient from a mold of the infant's head. The mold is modified and prepared for fabrication by the treating practitioner using mathematical analyses and plaster modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, an inner lining of hypoallergenic foam, a strap for securing the orthosis, and a polymer hinge and guiding system to maintain proper alignment of the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.

Executive Summary

The device in question is the "Static Cranioplasty Orthosis" (also referred to as "Cranial Molding Orthosis"), intended to treat abnormally shaped craniums in infants aged three to 18 months with nonsynostotic positional plagiocephaly. The submission indicates that no specific quantitative acceptance criteria or detailed study protocols were provided within the summary. Instead, the effectiveness was established by asserting its performance was "significantly effective" and "almost uniformly" to a predicate device based on a "pilot study" and "statistical analyses."

Acceptance Criteria and Device Performance

Study Details

The provided document describes the study in very general terms, lacking specific quantitative data, methodologies, or detailed results typically found in full clinical trials.

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not specified. The document mentions "clinical trials" and a "pilot study" but does not provide the number of subjects included in these studies.
   • Data Provenance: Not specified (e.g., country of origin, specific institutions). The studies are described as "conducted using the Static Cranioplasty Orthosis," implying they are specific to this device, but details are absent. It's noted they were "identical to those conducted using the predicate device." It's reasonable to infer a retrospective approach given the limited details provided about the study setup.

2. Number and Qualifications of Experts for Ground Truth: Not specified. There is no mention of experts establishing ground truth or their qualifications.

3. Adjudication Method: Not specified.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed or reported. This device is a physical orthosis, not an AI or imaging device where MRMC studies are typically applied.

5. Standalone Performance Study (Algorithm Only): Not applicable. This is a physical medical device, not an algorithm.

6. Type of Ground Truth Used: Not explicitly stated. Given the nature of plagiocephaly treatment, the "ground truth" would likely be based on clinical assessments and measurements of cranial symmetry and shape, probably verified by medical practitioners. However, the exact methods are not detailed.

7. Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "device" itself is a physical orthosis, custom-designed for each patient.

8. How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device. The custom design for each patient involves mathematical analyses and plaster modification techniques by the treating practitioner based on a mold of the infant's head.

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