(183 days)
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.
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Effectiveness | Significant effectiveness in correcting abnormal head shape (e.g., positional plagiocephaly, brachycephaly, scaphocephaly) in infants aged 3-18 months, without evidence of relapse post-treatment. Ability to improve results of surgical correction in severe cases, potentially eliminating further surgical intervention. | "The effects of treatment with cranial orthoses on infants have concluded that the devices are significantly effective in correcting abnormal head shape, without evidence of relapse following treatment." |
| Safety | Biocompatibility of materials, no skin irritation or toxic effects, designed to avoid improper migration or harmful pressure levels, smooth interior. | "The safety of the cranial orthoses is established under standard biocompatibility assessments for each material used... not expected to adversely affect the infants... materials are not reported to cause skin irritation or any toxic effects." |
| Intended Use | To passively hold prominent cranial regions of an infant's skull to improve cranial symmetry and/or shape. | The device is intended for this purpose, and its effectiveness (as described above) supports this intention. |
| Indications | Infants, 3 - 18 months of age, with abnormally shaped craniums with no outstanding cranial abnormalities, and a physician's RX ruling out craniosynostosis. | The device performs according to these indications. |
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.
§ 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)).