(225 days)
The KidCap™ is a cranial orthosis used to treat abnormally shaped craniums in infants between the ages of three (3) months to eighteen (18) months of age. It is designed to address abnormal cranial configurations classified as nonsynostotic positional plagiocephaly and post-operative nonsynostotic plagiocephaly. It includes infants with plagiocephalic, brachycephalic and scaphocephalic patterned head shapes, and post-operative craniosynostosis management. The KidCap™ utilizes the principles of static equilibrium to influence the cranial plates while utilizing an anatomical kinetic chain to influence the bones comprising the orbits, cheek structure, and lower mandible. The orthosis is designed to intimately contact the prominences of the expanding cranium, but will not initiate a force upon the cranium. The KidCap™ is only available if prescribed by a physician.
The KidCap" is a cranial orthosis used to treat abnormally shaped craniums in infants three (3) to eighteen (18) months of age. 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 orthosis is custom designed for each patient by obtaining a three-dimensional scan of the patient cranium using the Omega Scanner. The scan of the cranium is translated into a digital image of the shape in the Computer Aided Design (CAD) software. From the digital image a positive model is generated by Ohio Willow Wood using a CAD carver. The positive model is then used to manufacture the KidCap". The orthosis is composed of a rigid polymer shell, Durr Plex™ with biocompatible foam padding. The orthosis is held together with a polyethylene hinge, and two lateral guides composed of Polypropylene. The external pieces are adhered to the orthosis with polymer rivets that are countersunk into the interior for a smooth, unobtrusive transition with the orthosis.
The anterior and posterior sections of the orthosis are held secure with a 3/4" Velcro™ strap that encircles the posterior hemisphere of the orthosis has ventilation apertures to promote convectionary cooling as the patient perspires
The provided text describes the KidCap™ cranial orthosis and its substantial equivalence to a predicate device (Static Cranioplasty Orthosis K020448). However, it does not include detailed acceptance criteria or a study dedicated to proving the device meets specific performance criteria in terms of efficacy for treating cranial deformities.
Instead, the submission focuses on demonstrating substantial equivalence primarily through:
- Identical Indications for Use and Target Population: The device treats the same conditions in the same age range as the predicate.
- Similar Design and Materials: Both devices are bivalved polymer shells with padded interfaces and use similar materials.
- Similar Safety Characteristics: This includes biocompatibility, mechanical safety (non-mechanical), chemical safety (non-reactive with skin), anatomical sites, and electrical safety.
- Performance Claim: The predicate device "Effectiveness has been proven statistically significant by Paired T-tests of clinical data." For the KidCap™, performance is supported by "Software Validation, Process Validation, and Dimensional Equivalency Comparison for mold acquisition method."
The "studies" mentioned for the KidCap™ are primarily focused on validating the manufacturing process and the new mold acquisition method, not clinical efficacy or direct performance against acceptance criteria for treating cranial deformities.
Therefore, many of the requested sections about specific acceptance criteria and detailed study data for device performance in relation to those criteria cannot be fully extracted from the provided text for the KidCap™ itself, as the submission relies on substantial equivalence to the predicate's proven clinical effectiveness, and non-clinical testing for the manufacturing process.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical efficacy (e.g., specific reduction in cranial asymmetry indices). Instead, the "performance" for the KidCap™ is demonstrated through non-clinical validation of its manufacturing process and dimensional equivalency. The predicate device's performance is stated as "Effectiveness has been proven statistically significant by Paired T-tests of clinical data," implying the predicate met clinical acceptance criteria, which the KidCap™ is deemed equivalent to.
| Acceptance Criteria (Implied / For Predicate) | Reported Device Performance (KidCap™ / Supporting Data) |
|---|---|
| Clinical Effectiveness: Reduction in abnormal cranial configurations (nonsynostotic positional plagiocephaly, brachycephaly, scaphocephaly, post-operative craniosynostosis management). (Criteria not explicitly defined for KidCap™ but implied by equivalence to predicate) | For KidCap™: No direct clinical performance data provided. The device is deemed substantially equivalent to the predicate, which has proven effectiveness. |
| Supporting Data: Software Validation, Process Validation, and Dimensional Equivalency Comparison for mold acquisition method. | |
| Manufacturing Accuracy: Molds created by new method are dimensionally equivalent to previous method. | Measured Performance: Dimensional Equivalency Comparison Report (details not provided, but report supports equivalence). |
| Software Functionality: Omega Tracer Software (risk assessment, system requirement, installation, operational, performance qualified). | Measured Performance: Software Validation documents executed (risk assessment, system requirement specification, installation qualification, operational qualification, and performance qualification). |
| Process Control: Manufacturing process for KidCap™ is validated. | Measured Performance: Summary of process validation provided. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified for any clinical data. For the KidCap™ non-clinical testing (software, process, dimensional equivalency), the data is from internal validation studies.
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. The non-clinical testing described does not involve expert-established ground truth in the context of clinical assessment.
4. Adjudication Method for the Test Set
- Not applicable as the described "studies" are non-clinical validations (software, process, dimensional equivalency) and not clinical trials with expert adjudication.
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
- No MRMC comparative effectiveness study was done for the KidCap™. The device is a cranial orthosis, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as the device is a physical orthosis, not an algorithm. The software (Omega Tracer Software) is for scanning and mold design, but its "performance" is about accurate measurement and model creation, not autonomous clinical decision-making.
7. The Type of Ground Truth Used
- For Dimensional Equivalency Comparison: The "ground truth" would likely be the measurements obtained from the original method of plaster impressions, against which the 3D scan and CAD model measurements were compared. However, specifics are not provided.
- For Clinical Efficacy (for predicate, by inference): The predicate device's clinical data would have used clinical measures of cranial shape improvement as ground truth, likely assessed by medical professionals.
8. The Sample Size for the Training Set
- Not applicable as the device is a physical orthosis. The software (Omega Tracer) does not describe a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable as there is no mention of a training set or ground truth in the context of machine learning for this 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)).