(11 days)
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
| Acceptance Criteria (Hypothetical, as not explicitly stated in 510(k)) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility of skin-contacting materials | Information was provided on the biocompatibility of the skin-contacting materials. (No specific metrics or pass/fail criteria reported in this summary). |
| Effectiveness: Improvement in cranial symmetry and/or shape | Information was provided on the safety and effectiveness of the helmet. (No specific metrics, studies, or quantitative results showing "improvement" are detailed in this summary). |
| Custom-made fit and function | Each helmet is assembled individually, custom-made using a negative impression and plaster model to fit snugly in some areas and be recessed in others for reshaping. |
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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K013458
lop-2
510(k) Summary
Submitter
Children's Hospital 8200 Dodge Street Omaha, NE 68114-4113
Telephone: (402) 955-4173 Fax: (402) 955-6030
Date Prepared October 17, 2001
Trade Name None
Common Name Cranial Orthosis
Predicate Device
Gillette Children's Specialty Healthcare - CranioCap™
Device Description
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.
Intended Use
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.
Technological Characteristics
Each child with deformational plagiocephaly has a unique skull shape and size, with varying areas of the skull affected. Therefore, each cranial helmet is custom-made. The assembly of the cranial helmet begins with creating a negative impression of the head. From this a plaster model of the head is made. The plastic helmet with its foans lining is made using the plaster model, and is designed to fit snugly in some areas and is recessed in others. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.
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K013458
2 OF 2
Summary of Studies
1000 - 1000
:
Summary of Studies
Information was provided on the biocompatibility of the skin-contacting materials and on the safety and effectiveness of the helmet.
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OCT 2 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Children's Hospital c/o Ms. Connie Ficklin Regulatory and Clinical Research Institute, Inc. 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416
Re: K013458
Trade/Device Name: Cranial Helmet Regulation Number: 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: MVA Dated: October 17, 2001 Received: October 18, 2001
Dear Ms. Ficklin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Connie Ficklin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
l. Male n. Melburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
:
.
:
| 510(k) Number (if known): | K013458 |
|---|---|
| Device Name: | Cranial Helmet |
| Indications for Use: | The Children's Hospital cranial helmet is intended toapply passive pressure to prominent regions of aninfant's cranium in order to improve cranial symmetryand/or shape in infants from three to eighteen months ofage with moderate to severe non-synostotic positionalplagiocephaly, including infants with plagiocephalic-,brachycephalic-, and scaphocephalic-shaped heads. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over-The-Counter Use |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K013455 |
|---|---|
| --------------- | --------- |
§ 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)).