(301 days)
Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define gentle limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.
The MyCRO Band is a cranial orthosis intended for infants aged 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic-shaped heads. It works by applying mild pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. It is also indicated for adjunctive use in infants with surgically corrected synostosis who still have moderate-to-severe cranial deformities.
Because the MyCRO Band functions similarly to the predicate device (Orthomerica Products, Inc., STARband® K180109), the acceptance criteria are based on comparative testing rather than specific performance metrics. The summary provided outlines the types of non-clinical tests conducted and their successful completion, rather than specific numerical acceptance criteria.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Passed Cytotoxicity testing per ISO 10993-5:2009. |
| Passed Irritation and Sensitization testing per ISO 10993-10:2010. | |
| Scanner Evaluation | Utilized a worst-case challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility. Scanners compared to previously cleared devices and internal acceptance criteria. |
| Software Validation | Demonstrated software performance, interoperability, and ability to meet internal device specifications (IQ, OQ, PQ studies). |
| Simulated Cranial Fit | Fit Assessment performed using test samples additively manufactured from 3D images of representative simulated cranial shapes (using a previously cleared scanner). |
| Manufacturing Process | Included dimensional analysis and mechanical testing of test samples to evaluate additive manufacturing process performance, compared to the predicate device's process. |
| Indications for Use | Identical to the predicate device (K180109). |
| Technological Characteristics | Basic principles of operation and basic design are the same as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test set (e.g., number of test samples for fit assessment, number of scans for scanner evaluation). It refers to "test samples" and "representative simulated cranial shapes."
The data provenance (country of origin, retrospective/prospective) is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described appears to be primarily technical and comparative against established standards or predicate device characteristics, rather than requiring expert adjudication for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
An adjudication method is not mentioned, likely because the tests are technical and objective (e.g., passing a specific ISO standard, dimensional analysis, repeatability metrics).
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical cranial orthosis, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical cranial orthosis, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests appears to be:
- Biocompatibility: Established ISO standards (ISO 10993-5:2009, ISO 10993-10:2010).
- Scanner Evaluation: Known dimensions of a "worst-case challenge reference object" and the performance of previously cleared devices.
- Software Validation: Internal device specifications and criteria for interoperability.
- Simulated Cranial Fit Assessment: The fit of manufactured samples to "representative simulated cranial shapes" derived from 3D images.
- Manufacturing Process Validation: Dimensional analysis and mechanical testing, compared to the process used for the predicate device.
8. The sample size for the training set
This information is not applicable and not provided. The development and testing of this physical orthosis does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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)).