The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

Device Description

The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband and STARlight provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband and STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylenepolypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro® strap (1 ½' for STARband Side Opening and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is the addition of three new systems to use for 3dimensional shape capture, specifically, the 3dMDhead™ System, the 3dMDcranial™ System and the 3dMDflex™ System all distributed by 3dMD, Inc. These systems use a non-coherent (i.e. non-laser light) structured light source and triangulated cameras to capture shape data.

AI/ML Overview

The provided 510(k) summary (K140353) concerns the addition of three new 3D imaging systems (3dMDhead™ System, 3dMDcranial™ System, and 3dMDflex™ System) for use with the existing STARband® and STARlight® Cranial Orthosis. The primary goal of the submission is to demonstrate that these new 3D capture systems are substantially equivalent to previously cleared 3D imaging devices for the same cranial orthosis fabrication.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the 3dMD Systems are primarily based on demonstrating repeatability, reproducibility, and accuracy in shape capture, and biocompatibility of the materials used in the orthosis itself. The performance is assessed by substantiating equivalence to predicate devices and established methods.

Acceptance Criteria	Reported Device Performance
Shape Capture Repeatability & Reproducibility (for 3dMD Systems)	"The shape capture repeatability and reproducibility was evaluated and determined to be acceptable."Study Method: Utilized uniform shapes with known dimensions representing various sizes of pediatric patients (3-18 months). Compared the proposed device (3dMD Systems) to cast and predicate devices. Parameters included A-P (Anterior-Posterior) and M-L (Medial-Lateral) measurements.
Cranial Shape Capture Accuracy (for 3dMD Systems)	"An additional, Cranial Shape Capture Accuracy Study was performed concluding that the 3dMD Systems yield a safe and effective product that is substantially equivalent to the predicate device."Study Method: Utilized a representative cranial shape with predefined known dimensions. Compared the proposed device (3dMD Systems) to cast and predicate devices. Parameters included A-P, M-L, P-D (Posterior-Distal) and various Radius Parameters, Squareness, Flatness. Concluded substantial equivalence.
Biocompatibility (for STARband and STARlight materials - Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam)	Demonstrated acceptable biocompatibility:- Closed Patch Sensitization: All materials scored 0.00/0.00 (Test/Control) for Incidence and Severity at 24 and 48 hours, concluding "Not a Sensitizer," and "No Erythema or Edema Formation."- Primary Dermal Irritation: Surlyn scored 0.00, Copolymer with Pelite Foam scored 0.06, Copolymer with Aliplast Foam scored 0.00. All concluded "Negligible Dermal Response."- Cytotoxicity (Agar Diffusion): Surlyn and Copolymer with Pelite Foam exhibited no reactivity (Grade 0), concluded "Non-cytotoxic." Copolymer with Aliplast Foam exhibited slight reactivity (Grade 1), concluded "Non-cytotoxic."
Safety of Scanner Light Source (for 3dMD Systems)	"The scanner uses a quick flash of structured white light which is equivalent to the flash from a consumer grade camera and shown that is safe to use on infants without any extra eye protection." This references that the non-coherent light source is safe, similar to the predicate device K014012.

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

Sample Size for Repeatability & Reproducibility Analysis: Not explicitly stated as a number of "samples." The study "utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." This suggests a set of standardized models rather than clinical patient data.
Sample Size for Cranial Shape Capture Accuracy Study: Not explicitly stated as a number of "samples." The study "utilized a representative cranial shape that possesses a predefined shape with known dimensions." This also suggests a focus on physical models rather than patient data.
Data Provenance: The studies appear to be laboratory-based validation studies using physical models ("uniform shapes," "representative cranial shape") rather than retrospective or prospective clinical patient data. Therefore, country of origin related to patient data is not applicable.

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

The document does not mention the involvement of "experts" in establishing the ground truth for the test sets (uniform shapes, representative cranial shape). The ground truth was based on the "known dimensions" and "predefined shape" of these physical models.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on the known, predefined dimensions of physical models rather than human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or performed for this submission. The focus was on the accuracy, repeatability, and reproducibility of the 3D scanning systems themselves.

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

Yes, the studies conducted for the 3dMD Systems (Repeatability & Reproducibility Analysis, Cranial Shape Capture Accuracy Study) assessed the performance of the scanning technology in isolation, or "standalone," by comparing its measurements to the known dimensions of physical models. This does not involve a "human-in-the-loop" aspect for the performance evaluation of the scanner itself.

7. Type of Ground Truth Used

The ground truth used was based on the known dimensions and predefined shapes of physical models ("uniform shapes with known dimensions," "representative cranial shape that possesses a predefined shape with known dimensions").

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the context of machine learning. The 3dMD Systems are described as using "non-coherent (i.e. non-laser light) structured light source and triangulated cameras to capture shape data," which implies a direct measurement technology rather than a machine learning algorithm that requires a training set.

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

Not applicable, as a training set for a machine learning algorithm is not described in the document.

Summary

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510(k) Summary

K140353 JUN 0 6 2014

I. Applicant Information

Name:	Orthomerica Products, Inc.
Address:	6333 North Orange Blossom TrailOrlando, FL 32810
Telephone:	(407) 290-6592
Facsimile:	(407) 290-2419

FDA Establishment Registration Number

1058152

Contact Information

Contact Person:	David Hooper, Manufacturing Engineer
Address:	6333 North Orange Blossom TrailOrlando, FL 32810
Telephone:	(407) 290-6592
Facsimile:	(407) 290-2419
Email:	dhooper@orthomerica.com
Date Prepared:	February 7, 2014

II. Submission Information

Type:	Traditional 510(k) Submission
Proprietary Name:	STARband® and STARlight®
Common Name:	Cranial Orthosis
Classification:	Class II (special controls); OAN; MVA; 21 CFR 882.5970
Classification Name:	Cranial Orthosis

III. Manufacturer Site

Name:	Orthomerica Products, Inc.
Address:	6333 North Orange Blossom Trail
	Orlando, FL 32810
Telephone:	(407) 290-6592
Facsimile:	(407) 290-2419
FDA Establishment Registration Number:	1058152

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Description of Device/Modification IV.

The STARband and STARlight product families as it was released in K124023 and K133250 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylenepolypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

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capture shape data. Because these scanners utilize a non-coherent light source, they are safe to use on infant patients under all circumstances (equivalent to a Class 1 laser).

V. Statement of Indications and Intended Use

Statement of Indications:

Intended Use:

The STARband and STARlight are designed to treat infants with abnormal head shapes from age 3 to 18 months and is available by prescription only. Since growth is the driving factor in head shape correction, the infants wear the STARband or STARlight for . approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARband and STARlight have also been cleared to treat unresolved head deformities in patients who have undergone surgery to correct craniosynostosis. The same principles of cranial remolding apply to positional deformities and post-operative patients.

VI. Predicate Devices

l STARband, Cranial Orthosis, K124023
STARlight, Cranial Orthosis, K133250
Doc Band, K014012

Summary of Technological Characteristics VI.

The 3dMD Systems proposed in this 510(k) are additional methods to capture the infant's head shape for the fabrication of the STARband and STARlight Cranial Orthosis. The technological characteristics and the underlying principles of operation of the STARband and STARlight Cranial Orthosis shall remain exactly the same. The inclusion of the 3dMD Systems is the focus of this submission and that change is indicated in Table 1 under the Approved 3-Dimensional Imaging Devices section.

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STARband® and STARIight® Cranial Orthosis

Comparison of Predicate Devices cleared in K124023 and K133250 to the Proposed Devi Table 1 -

7-14

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STARband® and STARlight® Cranial Orthosi

・

7-15

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STARband® and STARlight® Cranial Orthosis

ﺮ ﻣ

7-16

, .

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The use of a non-coherent structured light and triangulated cameras for a shape capture system for manufacturing Cranial Orthosis received FDA 510(k) clearance under K014012 (Cranial Technologies, Inc.). The STARband and STARlight Cranial Orthosis have similar indications for use as the predicate Cranial Orthosis (K014012) and the proposed shape capture device also has the same technological characteristics as the predicate shape capture device. Therefore, the STARband and STARlight Cranial Orthosis are substantially equivalent to the predicate Cranial Orthosis.

The STARband and STARlight are essentially the same Cranial Orthosis. The main difference between the STARband and STARlight are the materials used to produce them. The STARband and STARlight materials have been biocompatibility tested, and the results of the tests are listed below in Table 2.

Material	Test	Results	Conclusion
Surlyn	Closed PatchSensitization	A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in the 24 hour and 48 hour scoring interval.	Not a SensitizerNo Erythema orEdema Formation
Surlyn	Primary DermalIrritation	Primary Irritation Index: 0.00	Negligible DermalResponse
Surlyn	Cytotoxicity -Agar Diffusion	Cell culture treated with test sample exhibited no reactivity (Grade 0).	Non-cytotoxic
Copolymer withPelite Foam	Closed PatchSensitization	A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in the 24 hour and 48 hour scoring interval.	Not a SensitizerNo Erythema orEdema Formation
Copolymer withPelite Foam	Primary DermalIrritation	Primary Irritation Index: 0.06	Negligible DermalResponse
Copolymer withPelite Foam	Cytotoxicity -Agar Diffusion	Cell culture treated with test sample exhibited no reactivity (Grade 0).	Non-cytotoxic
Copolymer withAliplast Foam	Closed PatchSensitization	A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in the 24 hour and 48 hour scoring interval.	Not a SensitizerNo Erythema orEdema Formation
Copolymer withAliplast Foam	Primary DermalIrritation	Primary Irritation Index: 0.00	Negligible DermalResponse
Copolymer withAliplast Foam	Cytotoxicity -Agar Diffusion	Cell culture treated with test sample exhibited slight reactivity (Grade 1).	Non-cytotoxic

Table 2 - Biocompatibility Testing Summary for STARband and STARlight Cranial Orthosis

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Summary and Conclusions of Non-Clinical Performance Data VII.

The 3dMDhead™ System, the 3dMDcranialTM System and the 3dMDflex™ System were all evaluated for safety and efficacy. The scanner uses a quick flash of structured white light which is equivalent to the flash from a consumer grade camera and shown that is safe to use on infants without any extra eye protection. The shape capture repeatability and reproducibility was evaluated and determined to be acceptable. An additional, Cranial Shape Capture Accuracy Study was performed concluding that the 3dMD Systems yield a safe and effective product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the scanner, the 3dMD Systems were determined safe and effective for scanning infants for STARband and STARlight Cranial Orthosis.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

June 6, 2014

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Orthomerica Products, Inc. Mr. David Hooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810

Re: K140353

Trade/Device Name: STARband and STARlight Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: May 5, 2014 Received: May 6, 2014

Dear Mr. Hooper:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 With an the required (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. David Hooper

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140353

Device Name

STARband and STARlight cranial orthosis

Indications for Use (Describe)

The STARband and STARlight is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

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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)).

	of Predicate Devices cleared in K124023 and K133250 to the Proposed DeviceFrom K124023 (STARband)	From K133250 (STARlight)	Proposed Device (STARband and STARlight)
Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry.	Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry.	Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry.
Outer shell of 5/32 copoly plastic	Material for STARlight Side Openingdesign and STARlight Bi-Valve design5/32" - 1/4" clear Surlyn or 1/8" -7/32" Clear Co-Polyester plasticshell	Material for STARband Side Openingdesign and STARband Bi-Valve designOuter shell of 5/32" copolymerplastic	Material for STARband Side Openingdesign and STARband Bi-Valve designOuter shell of 5/32" copolymerplastic
An inner liner of ½" Pelitepolyethylene foam or ½" Aliplastfoam	Material for STARlight PRO design1/4"-3/8" clear Surlyn	An inner liner of 1/2" pelitepolyethylene foam or 1/2"Aliplast foam	An inner liner of 1/2" Pelitepolyethylene foam or 1/2"Aliplast foam
A strap of 1 ½" Dacron	Material for STARband Bivalve designOuter shell of 5/32" copolymerplastic	Material for STARlight Side Openingdesign and STARlight Bi-Valve design5/32" - 1/4" clear Surlyn or 1/8" -7/32" Clear Co-Polyester plasticshell	Material for STARlight Side Openingdesign and STARlight Bi-Valve design5/32" - 1/4" clear Surlyn or 1/8" -7/32" Clear Co-Polyester plasticshell
A 1 ½" chafe buckle	An inner liner of 1/2" pelitepolyethylene foam or 1/2"Aliplast foam	Material for STARlight PRO design1/4"-3/8" clear Surlyn	Material for STARlight PRO design1/4"-3/8" clear Surlyn
Large Flange, Blind Rivet	Closure for Bivalve designSliding/Overlap closure systemChicago screw (or similar) for topsliding mechanism	Closure for Bivalve designSliding/Overlap closure systemChicago screw (or similar) for topsliding mechanism	Closure for Bivalve designSliding/Overlap closure systemChicago screw (or similar) for topsliding mechanism
A Gap Block made from ½" firmpelite polyethylene foam	1" Velcro strap1" chafe buckleSpeedy rivets	1" Velcro strap1" chafe buckleSpeedy rivets	1" Velcro strap1" chafe buckleSpeedy rivets
A nylon washer	Closure for Side Opening design and thePRO design:	Closure for STARband Side Openingdesign	Closure for STARband Side Openingdesign
	1" Velcro Strap1" chafe buckle	1" Velcro Strap	1" Velcro Strap
Feature	From K124023 (STARband)	From K133250 (STARlight)	Proposed Device (STARband and STARlight)
Product Design	Custom made cranial orthosis, approximately 6oz. in weight	Optional tamper resistant strap (qty 2 for the STARlight PRO design)Custom made cranial orthosis, approximately 7 to 10oz in weight. STARlight PRO weighs 12.5 to 18.5 oz.	1 ½" chafe buckleA Gap Block made from ½" firm Pelite polyethylene foamLarge Flange, Blind RivetClosure for STARlight Side Opening design and the STARlight PRO design:1" Velcro Strap.1" chafe buckleOptional tamper resistant strap (qty 2 for the STARlight PRO design)Custom made cranial orthosis, approximately 6 to 10oz in weight.STARlight PRO weighs 12.5 to 18.5 oz.
Production	Form orthosis from a positive mold of infant's headPositive mold is formed based upon measurements of the infant's head taken by an approved 3-dimensional imaging device from which a 3- dimensional image is made or from a traditional plaster cast	Form orthosis from a positive mold of infant's headPositive mold is formed based upon measurements of the infant's head taken by an approved 3-dimensional imaging device from which a 3- dimensional image is made or from a traditional plaster cast	Form orthosis from a positive mold of infant's headPositive mold is formed based upon measurements of the infant's head taken by an approved 3-dimensional imaging device from which a 3- dimensional image is made or from a traditional plaster cast
Approved 3- Dimensional Imaging Devices	The 3-dimensional image is used to produce a positive mold using a 5-axis routing machineSTARscanner ISTARscanner IIOmega ScannerscanGogh-II	The 3-dimensional image is used to produce a positive mold using a 5-axis routing machineSTARscanner ISTARscanner IIOmega ScannerscanGogh-II	The 3-dimensional image is used to produce a positive mold using a 5-axis routing machineSTARscanner ISTARscanner IIOmega ScannerscanGogh-II3dMDhead System
Feature	From K124023 (STARband)	From K133250 (STARlight)	Proposed Device (STARband andSTARlight)
Testing	Repeatability and Reproducibility (R&R)AnalysisUtilized uniform shapes withknown dimensions that representvarious sizes of pediatric patientsbetween ages 3 to 18 months ofageCompared proposed device tocast and predicate deviceAssociated parameters includesA-P and M-LProposed device is substantiallyequivalent to predicate device	Repeatability and Reproducibility (R&R)AnalysisUtilized uniform shapes withknown dimensions that representvarious sizes of pediatric patientsbetween ages 3 to 18 months ofageCompared proposed device tocast and predicate deviceAssociated parameters includesA-P and M-LProposed device is substantiallyequivalent to predicate device	3dMDcranial System3dMDflex SystemRepeatability and Reproducibility (R&R)AnalysisUtilized uniform shapes withknown dimensions that representvarious sizes of pediatric patientsbetween ages 3 to 18 months ofageCompared proposed device tocast and predicate deviceAssociated parameters includesA-P and M-LProposed device is substantiallyequivalent to predicate device
	Cranial Shape Capture Accuracy StudyUtilized a representative cranialshape that possesses a predefinedshape with known dimensionsCompared proposed device tocast and predicate deviceAssociated Coordinate Planes (A-P; M-L; P-D and various RadiusParameters; Squareness; Flatness)Proposed device is substantiallyequivalent to predicate device	Cranial Shape Capture Accuracy StudyUtilized a representative cranialshape that possesses a predefinedshape with known dimensionsCompared proposed device tocast and predicate deviceAssociated Coordinate Planes (A-P; M-L; P-D and various RadiusParameters; Squareness; Flatness)Proposed device is substantiallyequivalent to predicate device	Cranial Shape Capture Accuracy StudyUtilized a representative cranialshape that possesses a predefinedshape with known dimensionsCompared proposed device tocast and predicate deviceAssociated Coordinate Planes (A-P; M-L; P-D and various RadiusParameters; Squareness; Flatness)Proposed device is substantiallyequivalent to predicate device
	Material Biocompatibility TestingCytotoxicity-Agar DiffusionClosed Patch Sensitization	Material Biocompatibility TestingCytotoxicity -Agar DiffusionClosed Patch Sensitization	Material Biocompatibility TestingCytotoxicity-Agar DiffusionClosed Patch Sensitization