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, 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. These devices are 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.

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 provide 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 and STARlight product families as it was released in K141842 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" polyethylene-polypropylene 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 (1½" 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 a new 3-dimensional shape capture method, specifically, the Rodin4D M4DScan System and the BodyScan System. The BodyScan System is the same as the M4DScan System (Hardware and Software included) except it is distributed in the United States by TechMed 3D, Inc. on behalf of Rodin4D. This system uses a structured white light projector and a single camera to detect the shape of the surface captured. This system utilizes LED white light which is a non-coherent (i.e. non-laser) light source. Because this system utilizes a non-coherent light source, it is safe to use on infant patients under all circumstances.

AI/ML Overview

This document describes the 510(k) premarket notification for the STARband and STARlight Cranial Orthosis, specifically focusing on the addition of the Rodin4D M4DScan System and the BodyScan System as new 3-dimensional shape capture methods.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Repeatability and Reproducibility (R&R) Analysis	The new shape capture device (M4DScan/BodyScan) should demonstrate comparable repeatability and reproducibility to the casting process and the predicate device.	"The shape capture device passed the acceptance criteria. The relevancy of the test determined substantial equivalence of the proposed shape capture device." (Page 9)
Cranial Shape Capture Accuracy Study	The new shape capture device (M4DScan/BodyScan) should demonstrate comparable accuracy to the casting process and the predicate device for predefined cranial shapes and dimensions (A-P, M-L, P-D, radius parameters, squareness, flatness).	"The shape capture device passed the acceptance criteria for all parameters. The relevancy of the test determined substantial equivalence of the proposed shape capture device." (Page 9)
Material Biocompatibility Testing (Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam)	Materials used in the orthosis should be non-sensitizing, cause negligible dermal response, and be non-cytotoxic.	Surlyn: Not a Sensitizer, No Erythema or Edema Formation (Closed Patch Sensitization); Negligible Dermal Response (Primary Dermal Irritation); Non-cytotoxic (Cytotoxicity – Agar Diffusion).Copolymer with Pelite Foam: Not a Sensitizer, No Erythema or Edema Formation; Negligible Dermal Response; Non-cytotoxic.Copolymer with Aliplast Foam: Not a Sensitizer, No Erythema or Edema Formation; Negligible Dermal Response; Non-cytotoxic (Note: exhibited slight reactivity (Grade 1) in Cytotoxicity, but conclusion states Non-cytotoxic, implying it met the criteria). (Page 10)

Note on Acceptance Criteria: The document primarily states that the devices "passed the acceptance criteria" and demonstrated "substantial equivalence" rather than explicitly delineating numerical thresholds for acceptance. The acceptance criteria are inferred from the stated purpose of the tests (comparing to predicate/casting process and finding substantial equivalence).

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

R&R Analysis & Cranial Shape Capture Accuracy Study:
- Sample Size: The document states the tests "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" and "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" (Page 9). However, specific numerical sample sizes for the test set (number of uniform shapes, number of measurements, etc.) are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study appears to be a laboratory/benchtop study using uniform or representative cranial shapes, not patient data.

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

R&R Analysis & Cranial Shape Capture Accuracy Study: The ground truth was established by "predefined shape with known dimensions" of uniform or representative cranial shapes (Page 9). This implies that the ground truth was based on engineered or calibrated measurements of these physical models, not expert human assessment. Therefore, no experts were used to establish the ground truth for these specific tests.

4. Adjudication Method for the Test Set

Since the ground truth was based on precisely measured physical models or known dimensions, and not human interpretation, no adjudication method (like 2+1, 3+1) was necessary or performed.

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

No MRMC comparative effectiveness study was mentioned or performed. The clearance is for a medical device (cranial orthosis) and a new shape capture method, not an AI diagnostic algorithm that assists human readers.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was performed for the shape capture devices. The R&R Analysis and Cranial Shape Capture Accuracy Study directly evaluated the performance of the M4DScan/BodyScan System itself in accurately capturing known shapes, comparing its measurements to predefined dimensions (ground truth) and to other existing shape capture methods (casting process and predicate devices). This is essentially a standalone performance evaluation of the new technology.

7. The Type of Ground Truth Used

For the R&R Analysis and Cranial Shape Capture Accuracy Study: The ground truth used was based on "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions." This is akin to engineered ground truth or physical model measurements, where the true dimensions are precisely known.
For Biocompatibility Testing: The ground truth was established by recognized biological assay standards and methodologies (e.g., scoring systems for sensitization, irritation, and cytotoxicity) as per ISO 10993 standards (implied, though not explicitly cited in detail).

8. The Sample Size for the Training Set

This document is for a medical device and a shape capture method, not an AI model that requires a "training set" in the machine learning sense. The device is a physical orthosis and the M4DScan/BodyScan system is a 3D scanner.
Therefore, the concept of a "training set" as traditionally understood for machine learning models is not applicable here, and no specific training set sample size is mentioned.

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

As the concept of a "training set" is not applicable, the establishment of ground truth for a training set is also not relevant to this submission.

Summary

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Image /page/0/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 three human profiles facing right, with flowing lines beneath them.

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

July 1, 2015

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

Re: K151147

Trade/Device Name: Starband® and Starlight® Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: April 27, 2015 Received: Mav 5. 2015

Dear David 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S 同公

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) K151147

Device Name STARband® and STARlight®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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 Trail
	Orlando, FL 32810
Telephone:	(407) 290-6592
Facsimile:	(407) 290-2419
Email:	dhooper@orthomerica.com
Date Prepared:	April 27th, 2015

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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IV. Description of Device/Modification

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non-coherent (i.e. non-laser) light source. Because this system utilizes a non-coherent light source, it is safe to use on infant patients under all circumstances.

V. Statement of Indications and Intended Use

Statement of Indications:

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.

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

I STARband and STARlight, Cranial Orthosis, K141842

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VII. Summary of Technological Characteristics

The M4DScan/BodyScan System proposed in this 510(k) is an additional method 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 M4DScan /BodyScan System is the focus of this submission and that change is indicated in Table 1 under the Approved 3-Dimensional Imaging Devices section.

Feature	From K141842	Proposed Device
IntendedUse	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.
Materials	Material for STARband Side Openingdesign and STARband Bi-Valve design - Outer shell of 5/32" copolymerplastic - An inner liner of 1/2" Pelitepolyethylene foam or 1/2"Aliplast foam	Material for STARband Side Openingdesign and STARband Bi-Valve design - Outer shell of 5/32" copolymerplastic - An inner liner of 1/2" Pelitepolyethylene foam or 1/2"Aliplast foam
	Material for STARlight Side Openingdesign and STARlight Bi-Valve design - 5/32" - 1/4" clear Surlyn or 1/8" –7/32" Clear Co-Polyester plasticshell	Material for STARlight Side Openingdesign and STARlight Bi-Valve design - 5/32" - 1/4" clear Surlyn or 1/8" –7/32" Clear Co-Polyester plasticshell
	Material for STARlight PRO design - 1/4" - 3/8" clear Surlyn	Material for STARlight PRO design - 1/4"-3/8" clear Surlyn
	Closure for Bivalve design - Sliding/Overlap closure system - Chicago screw (or similar) for topsliding mechanism - 1" Velcro strap - 1" chafe buckle - Speedy rivets	Closure for Bivalve design - Sliding/Overlap closure system - Chicago screw (or similar) for topsliding mechanism - 1" Velcro strap - 1" chafe buckle - Speedy rivets
	Closure for STARband Side Openingdesign - 1 ½" Velcro Strap - 1 ½" chafe buckle - A Gap Block made from ½" firmPelite polyethylene foam	Closure for STARband Side Openingdesign - 1 ½" Velcro Strap - 1 ½" chafe buckle - A Gap Block made from ½" firmPelite polyethylene foam

			Table 1 - Comparison of Predicate Device cleared in K141842 to the Proposed Device
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Feature	From K141842	Proposed Device
	- Large Flange, Blind Rivet	- Large Flange, Blind Rivet
	Closure for STARlight Side Openingdesign and the STARlight PRO design:- 1" Velcro Strap- 1" chafe buckle- Optional tamper resistant strap(qty 2 for the STARlight PROdesign)	Closure for STARlight Side Openingdesign and the STARlight PRO design:- 1" Velcro Strap- 1" chafe buckle- Optional tamper resistant strap(qty 2 for the STARlight PROdesign)
Product	Custom made cranial orthosis,	Custom made cranial orthosis,
Design	approximately 6 to 10oz in weight.	approximately 6 to 10oz in weight.
	STARlight PRO weighs 12.5 to 18.5 oz.	STARlight PRO weighs 12.5 to 18.5 oz.
Production	- Form orthosis from a positivemold of infant's head	- Form orthosis from a positivemold of infant's head
	- Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast	- Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast
	- The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine	- The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine
Approved 3-	- STARscanner I	- STARscanner I
Dimensional	- STARscanner II	- STARscanner II
Imaging	- Omega Scanner- scanGogh-II	- Omega Scanner- scanGogh-II
Devices	- 3dMDhead System	- 3dMDhead System
	- 3dMDcranial System	- 3dMDcranial System
	- 3dMDflex System	- 3dMDflex System
	- SmartSoc System	- SmartSoc System- M4DScan/BodyScan System
Testing	Repeatability and Reproducibility (R&R)	Repeatability and Reproducibility (R&R)
	Analysis	Analysis
	- Utilized uniform shapes with	- Utilized uniform shapes with
	known dimensions that represent	known dimensions that represent
	various sizes of pediatric patientsbetween ages 3 to 18 months of	various sizes of pediatric patientsbetween ages 3 to 18 months of
	age	age
	- Compared proposed device to cast	- Compared proposed device to cast
	and predicate device	and predicate device
	- Associated parameters includes	- Associated parameters includes
	A-P and M-L- Proposed device is substantially	A-P and M-L- Proposed device is substantially
	equivalent to predicate device	equivalent to predicate device
	Cranial Shape Capture Accuracy Study	Cranial Shape Capture Accuracy Study
	Utilized a representative cranial	- Utilized a representative cranial

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Feature	From K141842	Proposed Device
	shape that possesses a predefinedshape with known dimensions- Compared proposed device to castand predicate device- Associated Coordinate Planes (A-P; M-L; P-D and various RadiusParameters; Squareness; Flatness)- Proposed device is substantiallyequivalent to predicate device	shape that possesses a predefinedshape with known dimensions- Compared proposed device to castand predicate device- Associated Coordinate Planes (A-P; M-L; P-D and various RadiusParameters; Squareness; Flatness)- Proposed device is substantiallyequivalent to predicate device
	Material Biocompatibility Testing- Cytotoxicity -Agar Diffusion	Material Biocompatibility Testing- Cytotoxicity -Agar Diffusion
	- Closed Patch Sensitization- Primary Dermal Irritation	- Closed Patch Sensitization- Primary Dermal Irritation

The STARband and STARlight Cranial Orthosis have already received FDA 510(k) clearance under K141842 for being manufactured from a 3-dimensional imaging device that utilizes a non-coherent light source and takes 2-dimensional (2D) images for shape capture (3dMD Systems and SmartSoc System). The M4DScan/BodyScan System utilizes the same technology as the FDA 510(k) cleared 3dMD and SmartSoc Systems of a non-coherent light source and takes continuous 2D images from triangulated positions for shape capture. Considering that STARband and STARlight are still the same device as it was in the predicate device and that the shape capture devices have the same technological characteristics; the STARband and STARlight Cranial Othosis are substantially equivalent to the predicate device.

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Test	Test Method Summary	Results
Repeatability and	The purpose of this test is to analyze	The shape capture device passed
Reproducibility	the repeatability and reproducibility	the acceptance criteria. The
(R&R) Analysis	(components of precision) of the	relevancy of the test determined
	proposed shape capture device. The	substantial equivalence of the
	data obtained is compared to the	proposed shape capture device.
	casting process and the predicate
	device.
	Utilized uniform shapes with known
	dimensions that represent various sizes
	of pediatric patients between ages 3 to
	18 months of age. Associated test
	parameters include A-P and M-L.
Cranial Shape	The purpose of this test is to analyze	The shape capture device passed
Capture Accuracy	the accuracy of the proposed shape	the acceptance criteria for all
Study	capture device. The data obtained is	parameters. The relevancy of the
	compared to the casting process and	test determined substantial
	the predicate device.	equivalence of the proposed shape
	Utilized a representative cranial shape	capture device.
	that possesses a predefined shape with
	known dimensions. Associated
	parameters analyzed include A-P, M-
	L, P-D, various radius parameters,
	squareness, and flatness.

Table 2 - Performance Testing Summary for STARband and STARlight 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 3.

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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 3 - Biocompatibility Testing Summary for STARband and STARlight Cranial Orthosis

Summary and Conclusions of Non-Clinical Performance Data VIII.

The M4DScan/BodyScan System was evaluated for substantial equivalence. The system uses flashes of structured light which is equivalent to the flash from a consumer grade camera and is safe to use on infants without 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 M4DScan/BodyScan System yields a product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the system, the M4DScan/BodyScan System was determined to have a safety and effectiveness profile similar to the predicate device for capturing infant head shape data to manufacture the STARband and STARlight Cranial Orthosis.

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)).