(122 days)
The Cranial Helmet (cranial orthosis) is a device that is intended for medical purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Contraindications: Infants with Synostosis or Hydroccphalus.
Prescription Device.
The Cranial Helmet is a cranial orthosis custom fabricated to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry and shape. The Cranial Helmet is comprised of the same materials as the P.A.P. Orthosis (K012804). It is not packaged for sale, as it is custom fabricated. It will be fitted to the infant at the time of delivery. The Cranial Helmet has no accessories, and no options are available for the infant or the caregiver (parent). Caregivers are instructed as to: wear, care, cautions, and risks. The transparent thermoplastic is Surlyn which varies in thickness from 1/8 inch to 3/8 inch depending upon the desired characteristics. The helmet is fabricated from a cast taken of an infant's head. There are no standard sizes, models, variances, etc. A polyurethane foam strip is applied to the posterior border at the base of the occipital to provide suspension and anti-rotation. Each Cranial Helmet is fastened with a Velcro strap. Each infant with a Cranial Helmet must be under the care of a physician. The helmet is a Prescription Device.
This 510(k) premarket notification for the Otto Bock Cranial Helmet does not include a study that proves the device meets specific performance acceptance criteria.
Instead, the submission relies on demonstrating substantial equivalence to a previously legally marketed device (the Fit Well's P.A.P. Orthosis, K012804). This means that the Cranial Helmet is deemed safe and effective because it has the same intended use and similar technological characteristics (materials, function, purpose, etc.) as the predicate device, which has already been cleared by the FDA.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not applicable to this type of submission.
Here's a breakdown of the information that is available based on the provided document:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on substantial equivalence rather than fulfilling specific performance metrics through a new study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable. No new performance study with a test set was conducted for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not Applicable. No new performance study with a test set was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. No new performance study with a test set was conducted.
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 device is a physical orthosis, not an AI software, and no comparative effectiveness study of this nature was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This device is a physical orthosis, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not Applicable. As no new performance study was conducted, there was no specific ground truth established for a test set. The "ground truth" for regulatory clearance is the substantial equivalence to the predicate device, implicitly relying on the established safety and effectiveness of that predicate.
8. The sample size for the training set:
Not Applicable. No AI model or algorithm was developed for this device; therefore, there is no training set.
9. How the ground truth for the training set was established:
Not Applicable. As no AI model or algorithm was developed, there is no training set or corresponding ground truth establishment.
Summary of Device Acceptance (based on provided text):
The Otto Bock Cranial Helmet was accepted by the FDA on the basis of Substantial Equivalence to the predicate device, Fit Well's P.A.P. Orthosis (K012804). The similarities cited for substantial equivalence include:
- Identical Indications for Use
- Same Materials (Surlyn, Polyurethane, Silicone and Velcro)
- Custom Fabrication
- Same Function
- Same Purpose
- Same Shape
- Same Diagnosis
- Prescription Devices
- Follow FDA Special Controls
The differences noted were minor (manufacturing location), which did not alter the fundamental safety and effectiveness profile compared to the predicate.
§ 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)).