The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads.

The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.

The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109

Device Description

The Cranial Symmetry System provides passive pressure to the prominent areas of the infants' skull while allowing for growth into the flattened areas. There are no exceeding pressures that could put restrictions on brain growth. The cranial orthosis helmet is custom fabricated with lightweight materials. The outer shell consists of a sheet of three-sixteenths inch thick polypropylene. The padded inner liner consists of three-sixteenths Aliplast. These materials are vacuumed formed over the modified plaster cast mold of the infants' skull. There is a Velcro chinstrap that is used as a method of suspension. The chinstrap is fastened securely through the Dacron loops at the cut out section for the infants' ears. The chinstrap holds the helmet in place eliminating the risk of slippage. There are air holes drilled into the helmet for ventilation.

AI/ML Overview

The provided text describes a 510(k) submission for the Cranial Symmetry System helmet. However, it does not include detailed acceptance criteria or a dedicated study section with specific performance data to prove the device meets such criteria. Instead, it relies on substantial equivalence to a predicate device and references two existing medical journal articles as "Performance Data."

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or provide specific details for points 2 through 9 as they are not present in the document.

Here's a breakdown of what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated or quantified in terms of specific performance metrics (e.g., percentage improvement in cranial symmetry, time to achieve symmetry).
Reported Device Performance: The document does not report performance metrics for the Cranial Symmetry System itself. It references two articles by Clarren et al. (1979 and 1981) for the general concept of helmet treatment for plagiocephaly and torticollis, implying that the methodology and technique are "gleaned" from this work. However, no specific data from these studies are presented to establish performance criteria or compare with the Cranial Symmetry System's performance.

2. Sample size used for the test set and the data provenance:

Sample Size: Not provided for the Cranial Symmetry System.
Data Provenance: Not provided for the Cranial Symmetry System. The referenced studies by Clarren et al. would contain this information for their studies, but not for the specific device under review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided anywhere in the document.

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

Not provided anywhere in the document.

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 is a medical device (helmet), not an AI diagnostic or image analysis 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 medical device (helmet), not an algorithm.

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

Not explicitly stated for the Cranial Symmetry System. The referenced studies would likely use clinical assessments or anthropometric measurements.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable/Not provided.

Summary of the document's approach to "Performance Data":

The manufacturer, Beverly Hills Prosthetics Orthotics, Inc., largely bases its submission on substantial equivalence to the predicate device, the Clarren Helmet (K003035).

Under the "Performance Data" section, instead of presenting new study data for the Cranial Symmetry System, it references two articles:

Clarren, Sterling, M.D., "Plagiocephaly and torticollis: Etiology, natural history, and helmet treatment, "Journal of Pediatrics, 98:1 (92-95)(Jan. 1981)
Clarren, et al., "Helmet treatment for plagiocephaly and congenital muscular torticollis," Journal of Pediatrics, 94:1 (43-46)(Jan. 1979)

The text states that "Helmet therapy was introduced to Beverly Hills Prosthetics Orthotics, Inc. by Sterling Clarren M.D. and therefore the methodology and technique for measurements and casting gleaned is still used in practice today." This suggests that the company adopted the principles and techniques from Dr. Clarren's work, rather than conducting a new performance study on their specific device and providing its data within this 510(k) submission. The conclusion explicitly states: "Based on the foregoing and all information included in this 510(k) application, Beverly Hills Prosthetics Orthotics, Inc. believes that the performance data provides reasonable assurance of the safety and effectiveness of the Cranial Symmetry System for its proposed indications for use. Further, the Cranial Symmetry System is substantially equivalent to its claimed predicate device under the conditions of intended use."

In essence, the "study that proves the device meets the acceptance criteria" in this 510(k) is the assertion of substantial equivalence to a legally marketed predicate device, supported by the general scientific literature on the efficacy of helmet therapy for plagiocephaly using methods derived from the referenced works. Specific, quantifiable performance data for the Cranial Symmetry System itself is not provided in this document.

Summary

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Beverly Fills Prosthetics Orthotics, Inc.

9 2002 SEP

6300 Wilshire Boulevard, Suite 150 Los Angeles, CA 90048 (323) 866-2555 Fax (323) 866-2560

K022273 510(k) Number:

15230 Burbank Boulevard, Suite 103 Van Nuys, CA 91411 (818) 988-0033 Fax (818) 988-7219

510(k) SUMMARY (as required by section 807.92(c)) CRANIAL SYMMETRY SYSTEM

BEVERLY HILLS PROSTHETICS ORTHOTICS, INC.

This 510(k) summary of safety and effectiveness for the Cranial Symmetry System helmet is submitted in accordance with requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant: Beverly Hills Prosthetics Orthotic
6300 Wilshire Blvd., Suite 150 Address: Los Angeles, CA 90048

Keith E. Vinnecour, President, C.P.O. Contact Person:

Telephone: 323-866-2555 (telephone) 323-866-2560 (facsimile)

March 21, 2002 Preparation date:

Cranial Symmetry System Device Trade Name:
Common Name: Cranial Orthosis

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

MVA Product Code:

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Predicate Device: Clarren Helmet, 510(k) number K003035 Beverly Hills Prosthetics Orthotics, Inc. is claiming substantial equivalence with Cranial Symmetry System to the legally marketed device Clarren Helmet (K003035) per 807.92(a)(3).

The Cranial Symmetry System provides passive Device Description: pressure to the prominent areas of the infants' skull while allowing for growth into the flattened areas. There are no exceeding pressures that could put restrictions on brain growth. The cranial orthosis helmet is custom fabricated with lightweight materials. The outer shell consists of a sheet of three-sixteenths inch thick polypropylene. The padded inner liner consists of three-sixteenths inch Aliplast. These materials are vacuumed formed over the modified plaster cast mold of the infants' skull. There is a Velcro chinstrap that is used as a method of suspension. The chinstrap is fastened securely through the Dacron loops at the cut out section for the infants' ears. The chinstrap holds the helmet in place eliminating the risk of slippage. There are air holes drilled into the helmet for ventilation.

Intended Use: The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads.

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Indications For Use:

The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109

Technological Characteristics

Compared to Predicate Device: The Cranial Symmetry System and the predicate device (The Clarren Helmet) are both classified as cranial orthosis (21CFR882.5970). The Cranial Symmetry System uses a 3/16" thickness polypropylene and the Clarren Helmet uses a 3/8" thickness polypropylene. The padded lining in the Cranial Symmetry System helmet is a 3/16" thickness Aliplast and the Clarren Helmet uses a 1/4" thick Plastizote. Both are closed cell copolymer foams. Both helmets are custom fabricated by vacuum forming the materials over the modified cast mold of the infant's skull. There are cutouts for the ears in bot designs, as well as air holes for ventilation. Helmet therapy was introduced to Beverly Hills Prosthetics Orthotics, Inc. by Sterling Clarren M.D. and therefore the methodology and technique for measurements and casting gleaned is still used in practice today.

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Performance Data: Clarren, Sterling, M.D., "Plagiocephaly and torticollis: Etiology, natural history, and helmet treatment, "Journal of Pediatrics, 98:1 (92-95)(Jan. 1981); Clarren, et al., "Helmet treatment for plagiocephaly and congenital muscular torticollis," Journal of Pediatrics , 94:1 (43-46)(Jan. 1979). Conclusions: Based on the foregoing and all information included in this 510(k) application, Beverly Hills Prosthetics Orthotics, Inc. believes that the performance data provides reasonable assurance of the safety and effectiveness of the Cranial Symmetry System for its proposed indications for use. Further, the Cranial Symmetry System is substantially equivalent to its claimed predicate device under the conditions of intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a cascading manner. The profiles are rendered in black and have a flowing, abstract design. Encircling the profile graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9 2002

Keith E. Vinnecour, President, C.P.O. Beverly Hills Prosthetics Orthotics, Inc. 6300 Wilshire Blvd., Suite 150 Los Angeles, California 90048

Re: K022273

Trade/Device Name: Cranial Symmetry System Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: July 11, 2002 Received: July 25, 2002

Dear Mr. Vinnecour:

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. Ilsting 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 - Mr. Keith E. Vinnecour

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,

Stipt Rwdrs
Dr. Colin McWee Ph.D., M.P.

a 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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510(k)Number: K022273

INDICATIONS FOR USE OF THE CRANIAL SYMMETRY SYSTEM HELMET

11.000

The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.

The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109

Stipt Ruvde

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_KO22273

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)).