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The AOI Cranial Helmet 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 age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic- shaped heads.

The AOI Cranial Helmet is a cranial orthosis which is made through a custom fabrication process to apply mild pressure to prominent regions of a young child's cranium to slow further growth in that area while allowing flattened portions of the cranium to grow into voids built into the helmet in order to improve overall cranial symmetry. The helmet itself, once finished and delivered, covers the majority of the head and is trimmed as follows. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above the ears. The posterior inferior is trimmed low to capture the occiput. A Velcro strap is attached to one side of the helmet to keep it securely in place. The finished AOI Cranial Helmet is composed of a hard outer shell, made of thermoform-able plastic (Copolymer 5/32 inch) and an inner layer of polyethylene foam ( 1/2 inch).

The provided document is a 510(k) summary for the AOI Cranial Helmet, a custom-fabricated cranial orthosis. The document aims to demonstrate substantial equivalence to a predicate device, the OPIBand by Orthomerica (K001167), rather than conducting independent clinical trials or establishing new acceptance criteria.

Therefore, the sections of your request related to specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not directly applicable or available in the provided text. The submission focuses on comparing the new device's design, materials, and intended use to a previously cleared predicate device.

Here's an analysis of the provided information, addressing what is present and noting what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria with quantifiable metrics are provided in the document for the AOI Cranial Helmet's performance. The basis for acceptance is demonstrating "substantial equivalence" to the predicate device.

2. An inner liner of 1/2 inch pelite polyethylene foam or Aliplast foam.
3. 1 1/2 in. Dacron Strap
4. Gap block 1/2 inch firm pelite polyethylene foam.
5. Nylon Washer | 1. Outer rigid shell made of 5/32 inch copolymer plastic.
6. Inner liner of 1/2 inch polyethylene foam.
7. 1 1/2 inch Dacron Strap.
8. 1 1/2 inch Chafe with roller loop.
9. Nylon Washer
10. Gap Block 1/2 inch firm pelite polyethylene foam. |
    | Product Design | Custom made cranial orthosis, approx 6 oz. | Custom made cranial orthosis, approx. 6 oz. |
    | Indications for Use | "The OPIBand 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- and brachycephalic- shaped heads." | The AOI Cranial Helmet 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 age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic- shaped heads. |
    | Contraindications | "This device is not for use on infants with pre-surgical craniosynostosis or hydrocephalus." | The AOI Cranial Helmet is not for use on infants with craniosynostosis or hydrocephalus. |

The reported performance is based on the claim that "The proposed AOI Cranial Helmet does not differ substantially from the predicate device. The predicate is made of the same materials and in the same fashion as the AOI proposed device." Thus, its "performance" is inferred to be equivalent to the predicate.

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

Not applicable. No new clinical trials or test sets were conducted for the AOI Cranial Helmet as part of this 510(k) submission. The submission relies on demonstrating substantial equivalence to a previously cleared device. The safety and effectiveness are inferred from the predicate device's history and the biocompatibility assessments of the materials used, which have a "demonstrable history of use."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No new test set requiring expert ground truth establishment was used for this submission. The effectiveness is largely based on the established safety and efficacy of the predicate device and the common materials used.

4. Adjudication Method for the Test Set

Not applicable. As no new test set was conducted that required expert review or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical cranial orthosis, not an imaging analysis or diagnostic AI tool that would typically involve an MRMC study to assess human reader improvement with or without AI assistance. The submission focuses on device design and material equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The AOI Cranial Helmet is a physical medical device, not an algorithm or software. Its application always involves human-in-the-loop (Certified Orthotist, treating physicians, caregivers).

7. Type of Ground Truth Used

The "ground truth" for the device's acceptability in this submission is the demonstrated safety and effectiveness of the legally marketed predicate device (OPIBand K001167) and the established biocompatibility and safe use history of the materials used in its construction. The submission explicitly states: "The safety of cranial helmets has also been shown through past biocompatibility assessments," and "no testing is needed if the material has a demonstrable history of use in a specified role that is equivalent to that of the device under design." Reference is made to a publication for the "Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty" (Littlefield et al., 1988), which presumably supports the general effectiveness of such devices.

8. Sample Size for the Training Set

Not applicable. As this is not an AI/algorithm-based device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no concept of a "training set" for this physical device.

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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 Molded Cranial Helmet is used to treat children 3-18 months of age for moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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. The device is for use by or on the order of a physician.

The Molded Cranial Helmet is a cranial orthosis used to treat children 3-18 months of age for moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The Molded Cranial Helmet consists of a 1/8" light-weight, semi-rigid polypropylene outer shell and a ¼'' medium-density closed cell plastazote foam inner lining. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above and around the ears. The posterior inferior is trimmed low to capture the occiput. A Velcro strap is attached on one side of the Helmet to keep it securely in place. The device allows for growth of the flattened areas of the infant's skull into the voids of the shell/foam lining, thus correcting the plagiocephaly and giving the infant's skull a more symmetrical shape.

The Molded Cranial Helmet is custom designed and custom-fit for each patient from a plaster mold of the infant's head. The mold is prepared by an orthotist using precise measurements of the infant's skull and plaster modification techniques. The orthosis is fabricated from the mold by lab technicians, with the trimming and final modifications performed by the orthotist. Precise fit and alignment are monitored by the orthotist during treatment.

The provided text describes a 510(k) summary for the "Molded Cranial Helmet," a cranial orthosis. It includes information about the device, its intended use, comparison to a predicate device, and performance data. However, it does not contain the specific details required to fully address your request in the format of a clinical study acceptance criteria and results.

Here's a breakdown of what can be extracted and where the information is missing:

The document does not detail specific, quantified acceptance criteria in the format of a table, nor does it present device performance data against such criteria in a systematic way that would typically be found in a clinical study report. Instead, it refers to general efficacy and safety.

Given the information provided in the 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Not Applicable (based on the provided text):

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 mentions "a comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over nearly ten years." This appears to be a retrospective analysis of treatment outcomes.
• Data provenance (country of origin) is not explicitly stated, but Fairview Orthopedic Laboratory is located in Minneapolis, MN, USA.

The text does not specify the sample size used for a test set in the context of a controlled study designed to prove the device meets specific acceptance criteria. The 750+ infant assessment seems to be a broader observational study or review of clinical practice.

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 specified. The assessment mentions "Fairview orthotists" who concluded effectiveness and observed results, but the number and specific qualifications for establishing ground truth are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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 medical device (cranial orthosis), not an AI-assisted diagnostic tool for human "readers."

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

• Not applicable. This is a physical device, not an algorithm. Performance is inherently "standalone" in this context but not in the way an AI algorithm's standalone performance is evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for efficacy appears to be "correction of asymmetry" as documented by healthcare professionals (orthotists) based on clinical observation and measurements taken at various follow-up periods. Safety ground truth is based on observation of adverse events and material biocompatibility. This broadly falls under "outcomes data" and "expert assessment."

8. The sample size for the training set

• Not applicable. This refers to an AI/machine learning context, which is not relevant for this physical medical device.

9. How the ground truth for the training set was established

• Not applicable (see above).

In summary, the provided 510(k) focuses on demonstrating substantial equivalence to a predicate device and relies on existing literature and clinical experience (including an assessment of over 750 infants) to support the safety and efficacy of cranial orthoses in general, and by extension, this specific device. It does not present a de novo clinical study with pre-defined acceptance criteria and a structured evaluation of performance against those criteria in the manner expected for a novel AI or diagnostic device.

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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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