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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Efficacy: Correction of moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads in infants 3-18 months of age.	"Researchers studying the effects of treatment with cranial orthoses on infants with plagiocephaly, including Fairview orthotists, have concluded that the devices are effective in correcting plagiocephaly without evidence of relapse after treatment." "A comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over nearly ten years. Results recorded at the end of the treatment period and at 12, 18, and 24 month follow-ups documented complete or near complete correction of asymmetry."
Safety: No adverse events, no skin irritation or abrasion, no improper slippage or excessive pressure on the infant's cranium. Biocompatibility with skin.	"Fairview orthotists have experienced similar results, having treated infants for positional plagiocephaly and observing significant improvement in head shape with no adverse events." "Plastazote is not reported to cause skin irritation or abrasion and is widely accepted in the industry as a safe material for skin contact." "the device is custom-designed and custom-fit for each patient, thus avoiding improper slippage or excessive pressure on the infant's cranium."

Acceptance Criteria

Reported Device Performance

Efficacy: Correction of moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads in infants 3-18 months of age.

"Researchers studying the effects of treatment with cranial orthoses on infants with plagiocephaly, including Fairview orthotists, have concluded that the devices are effective in correcting plagiocephaly without evidence of relapse after treatment." "A comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over nearly ten years. Results recorded at the end of the treatment period and at 12, 18, and 24 month follow-ups documented complete or near complete correction of asymmetry."

Safety: No adverse events, no skin irritation or abrasion, no improper slippage or excessive pressure on the infant's cranium. Biocompatibility with skin.

"Fairview orthotists have experienced similar results, having treated infants for positional plagiocephaly and observing significant improvement in head shape with no adverse events." "Plastazote is not reported to cause skin irritation or abrasion and is widely accepted in the industry as a safe material for skin contact." "the device is custom-designed and custom-fit for each patient, thus avoiding improper slippage or excessive pressure on the infant's cranium."

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.

Summary

{0}------------------------------------------------

K012920

510(k) SUMMARY

NOV 2 8 2001

Applicant Information A.

Submitter: Fairview Orthopedic Laboratory, Fairview Rehabilitation Services, Orthotics and Prosthetics, Chicago Avenue Clinic, 910 E. 26th Street, Suite 400, Minneapolis, MN 55404

Contact: Carol Hentges, Certified Orthotist and Supervisor. Telephone: (612) 870-1208; Fax: (612) 870-1223

Date: [Date]

B. Device Name and Classification

Proprietary or Trade Name: Molded Cranial Helmet

Common or Usual Name: Cranial Orthosis

Classification Name: Cranial Orthosis (21 C.F.R. § 882.5970)

Predicate Device: DOCTM Band, Cranial Orthosis, K964992

C. Device Description

{1}------------------------------------------------

Intended Use D.

The Molded Cranial Helmet is used to treat infants 3-18 months of age for moderate to The Molded Crainal Homier is assus ocephaly, including infants with plagiocephalic-, Severe nonsynostone positional prig-shaped heads. The device is intended for medical oracityeephane , and seaple of minent regions of an infant's cranium in order to purposes to apply prossure to promise. The device is used by or on the order of a physician.

Comparison to the Predicate Device /Technological Characteristics E.

The Molded Cranial Helmet and the predicate device are very similar with respect to The Molded Crainal Tremier and use, and special controls. Both devices consist of a material, design, production, minner lining. Both devices are custom designed for infants plastio outer shoricated from custom-made plaster impressions of the infant's skull.

The most significant difference between the two devices is the material used for the foam inner lining. The predicate device uses a polyurethane foam inner lining, whereas the inner iming. The product Cranial Helmet is made from plastazote. Plastazote does not miner mining of the Moraca Craness concerns, however. Plastazote is accepted in the pressincity as a material that can safely come into contact with skin and not cause severe mdustry as a material tim. Plastazote is listed in the Material Safety Data Sheet, which describes plastazote as "polyethylene foam" and states that there are no skin exposure effects associated with its use.

Performance Data F.

The safety and efficacy of cranial orthoses, like the Molded Cranial Helmet, have been The barrers and studies. Stests and studies. Researchers studying the effects of treatment with cranial orthoses on infants with plagiocephaly, including Fairview orthotists, have concluded that the devices are effective in correcting plagiocephaly without evidence of relapse after treatment. A comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over nearly ten years. Results recorded at the end of the treatment period and at 12, 18, and 24 month follow-ups documented complete or near complete correction of asymmetry. Fairview orthotists have experienced similar results, having treated infants for positional plagiocephaly and observing significant improvement in head shape with no adverse events.

The safety of the cranial orthosis is also established under biocompatibility assessments which reveal that the device is not expected to adversely affect infants under intended conditions of wear. The material used for the foam inner lining of the Molded Cranial Helmet, plastazote, is the only material on the device to come into contact with the skin and therefore is the only material that raises biocompatibility considerations. Plastazote is not reported to cause skin irritation or abrasion and is widely accepted in the industry as a safe material for skin contact. In addition, the safety of the device is further

{2}------------------------------------------------

evidenced by the fact that it is custom-designed and custom-fit for each patient, thus avoiding improper slippage or excessive pressure on the infant's cranium. Finally, the fit and function of the Molded Cranial Helmet are closely monitored by Fairview orthotists during treatment.

Labeling: G.

Labeling is provided with this 510(k) Summary.

Performance Standards: H.

There are no performance standards. Special controls are required. 21 C.F.R. § 882.5970; 63 Fed. Reg. 40,650-51 (July 30, 1998).

Published Literature: I.

Clarren SK, M.D. Plagiocephaly and Torticollis: Etiology, Natural History, and 1) Helmet Treatment. J. of Pediatrics 1981; 98 (1): 92-95.
Ripley CE, et al. Treatment of Positional Plagiocephaly with Dynamic Orthotic 2) Cranioplasty. J. Craniofacial Surgery 1994; 5 (3): 150-159.
Marshall D, M.D. Abnormal Head Shape in Infants. International Pediatrics, J. 3) of Miami Children's Hospital 1997; 12 (3): 172-177.
Pollack IF, M.D. Diagnosis and Management of Posterior Plagiocephaly. 4) Pediatrics 1997; 99 (2): 180-185.
Littlefield, TR et al. Treatment of Craniofacial Asymmetry With Dyanmic ર) Orthotic Cranioplasty. J. Craniofacial Surgery 1998; 9 (1): 11-17.
Kelly KM, Ph.D. Importance of Early Recognition and Treatment of 6) Deformational Plagiocephaly with Orthotic Cranioplasty. Cleft Palate-Craniofacial J. 1999; 36 (2): 127-130.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2001

Fairview Orthopedic Laboratory Mr. Ross D'Emanuele C/O Dorsey & Whitney LLP Pillsbury Center South 220 South Sixth Street Minneapolis, Minnesota 55402-1498

K012920 Re:

Molded Cranial Helmet Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: August 27, 2001 Received: August 30, 2001

Dear Mr. D'Emanuele:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becater been the device is substantially equivalent (for the Iteleficed above and nave determined re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate colliments, or to thay 20, 1978, and cardance with the provisions of Amendinens, of to devices mat nave obch (Act) that do not require approval of a premarket the Federal Food, Drug, and Oosmetto : 100 crown ... ......................................................................................................................... approval application (1 Mr ). - 1 Jan 1 - 1 Jan 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 controls provisions of aregistration, 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 If your device is chabition (500 as additional controls. Existing major regulations affecting (FMA), it may of subject to back adding the end Regulations, Title 21, Parts 800 to 898. In your device can oe found in the Seas nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not I reast that FDA has made a determination that your device complies with other requirements moan that I Dri has made a decembers and regulations administered by other Federal agencies. of the Act of ally I edelar statutes and reguirements, including, but not limited to: registration

{4}------------------------------------------------

Page 2 - Mr. Ross D'Emanuele

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.

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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Mark N. Matheson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

{5}------------------------------------------------

Page | of |

510(k) Number (if known): __ 012920 canial Helmet Device Name: 110 del

Indications For Use:

The Molded Cranial Helmet is used to treat children 3-18 months of age for moderate to
r and the states the since and class and she including informs with plagiocenhalic-The Molded Cranial Helmer is used to treat charge infants with plagiocephalic-,
severe non-synostotic positional plagiocephaly, including infended for medical severe non-synostouc positional plagioccphalis, The device is intended for medical
brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical brachycephalic-, and scaphocephanic-snapcanadas- infrant's cranium in order to
purposes to apply pressure to prominent regions of an infant's cranium in order to purposes to apply pressure to prominent regions of an mind. 100
improve cranial symmetry and/or shape. The device is for use by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Millican

Restorative

510(k) Number

(Optional Format 3-10-98)

Regulation Number and Section

§ 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)).