(109 days)
The Boston Band Cranial Molding 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 eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, 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 cast of the infant's head , a scan using the STARscanner from Orthomerica, or a scan from the Hand held FastScan Handheld Laser Scanner. The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathernatical 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.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured as requested:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Effectiveness: Significantly effective in correcting abnormal head shape. | "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: Device and materials are not expected to adversely affect infants; materials not reported to cause skin irritation or toxic effects; designed to avoid improper migration or harmful pressure. | "The safety of the cranial orthoses is established under standard biocompatibility assessments for each material used... These assessments reveal that the device and the materials used are not expected to adversely affect the infants under the intended conditions of use... The materials are not reported to cause skin irritation or any toxic effects. Further, the product is designed to avoid improper migration or harmful levels of pressure." |
| Substantial Equivalence: Analogous to predicate device in production, instructions for use, materials, safety, and effectiveness. | "The Static Cranioplasty Orthosis and the predicate device are very similar with respect to production, instructions for use, materials, safety and effectiveness and special controls." "The proposed indications of use are analogous to those presented by the predicate device, and biocompaibility, function and effectiveness further parallel those of the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The text refers to "clinical trials" and "infants" in a general sense, but no specific number of patients or cases is mentioned for the effectiveness study.
- Data Provenance: Retrospective or Prospective is not specified. The study cited, "Orthotic Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s," is a published clinical trial, suggesting prospective data collection, but this is an inference, not explicitly stated in the summary. The origin (country) is not specified, but the applicant is based in Avon, MA, USA, suggesting a US-based study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not explicitly stated. The document refers to "clinical trials" which implies that clinicians (likely orthopedic specialists, pediatricians, or orthotists) would be involved in patient assessment and outcome evaluation, but their specific roles in establishing ground truth (e.g., severity of plagiocephaly, correction) and their qualifications are not detailed.
4. Adjudication Method for the Test Set
Not explicitly stated. The nature of the study (clinical trial for a physical orthosis) is less likely to involve a formal adjudication method like 2+1 or 3+1 typically seen in diagnostic AI studies, as the "ground truth" would be the patient's physical head shape and its improvement over time, likely measured by practitioners or specialized equipment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The document describes a clinical trial evaluating the effectiveness of the device itself, not comparing human readers' performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
This question is not applicable to the device described. The Boston Band Cranial Remolding Orthosis is a physical medical device, not an AI algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. Its "performance" is its physical effect on the infant's skull when worn.
7. The Type of Ground Truth Used
The ground truth appears to be based on clinical outcomes data related to the correction of abnormal head shape. The text states, "The effects of treatment with cranial orthoses on infants have concluded that the devices are significantly effective in correcting abnormal head shape..." This suggests that clinical assessments and measurements (though not detailed) of head shape before and after treatment served as the ground truth for effectiveness.
8. The Sample Size for the Training Set
This question is not applicable. The Boston Band Cranial Remolding Orthosis is a physical medical device, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of device.
§ 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)).