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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.

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The Children's Hospital cranial helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The Children's Hospital cranial helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a lightweight, semi-rigid plastic helmet with a foam lining. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other recessed areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.

The provided document K013458 for the "Cranial Helmet" (cranial orthosis) does not contain a study that proves the device meets specific acceptance criteria in the way described in the request. This document is a 510(k) summary submitted to the FDA for market clearance, making a claim of substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing the points you requested:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The 510(k) summary for K013458 states, "Information was provided on the biocompatibility of the skin-contacting materials and on the safety and effectiveness of the helmet." However, it does not provide any specific acceptance criteria (e.g., a numerical threshold for improvement, pass/fail rates for specific tests) nor does it report detailed performance data or a study demonstrating how these criteria were met. The summary indicates that the device's safety and effectiveness were affirmed, likely through a combination of predicate device equivalence and internal testing/documentation that is not fully detailed in this public summary.

2. Sample Size Used for the Test Set and the Data Provenance

The 510(k) summary does not mention any specific sample size for a test set or the provenance of any data used for validation studies. The "Summary of Studies" section is very brief and only states that information was provided on biocompatibility, safety, and effectiveness. It does not describe a clinical study or a test set of patients.

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 510(k) summary. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the 510(k) summary. Since no specific test set or study results are detailed, there is no mention of an adjudication method.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical cranial orthosis, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study with human readers would be relevant. The 510(k) pertains to a medical device's physical and functional properties, not an AI algorithm's performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical product (cranial helmet), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The 510(k) summary does not detail any specific ground truth type as it does not describe a study involving data classification or diagnostic accuracy. The implicit "ground truth" for a cranial orthosis would be the clinical assessment of cranial symmetry improvement over time, but no such data or its establishment method is presented in this document. Substantial equivalence claims often rely on the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. Given that it's a physical medical device and not an AI/software product, there wouldn't typically be 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/provided as there is no mention of a training set or its ground truth establishment, due to the nature of the device (physical cranial orthosis vs. AI/software).

Conclusion:

The provided 510(k) summary for the Children's Hospital Cranial Helmet focuses on describing the device, its intended use, and its technological characteristics. It makes a general statement about information being provided on biocompatibility, safety, and effectiveness. However, it does not include a detailed study report that specifies acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert involvement in the manner typically expected for algorithmic or diagnostic device studies. The clearance is based on substantial equivalence to a predicate device (Gillette Children's Specialty Healthcare - CranioCap™), implying that the safety and effectiveness of the new device are comparable to that of the already marketed predicate.

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