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. The 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 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 Vorum Spectra™ 3D Scanner uses a high quality LED structured light projector and a single camera to detect the shape of the surface captured. This scanner utilizes LED light which is a non-coherent (i.e. non-laser) light source.

AI/ML Overview

This document describes the acceptance criteria and study proving the device meets these criteria for the STARband® and STARlight® Cranial Orthosis, specifically focusing on the addition of the Vorum Spectra™ 3D Scanner as a new method for capturing infant head shape.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Repeatability & Reproducibility (R&R) Analysis	To demonstrate that the proposed shape capture device (Spectra 3D Scanner) shows similar repeatability and reproducibility to the casting process and the predicate device for parameters like A-P (Anterior-Posterior) and M-L (Medial-Lateral) dimensions.	The shape capture device passed the acceptance criteria, demonstrating substantial equivalence to the predicate device.
Cranial Shape Capture Accuracy Study	To demonstrate that the proposed shape capture device (Spectra 3D Scanner) shows similar accuracy to the casting process and the predicate device for parameters like A-P, M-L, P-D (Posterior-Divergency), various radius parameters, squareness, and flatness using a predefined cranial shape with known dimensions.	The shape capture device passed the acceptance criteria for all parameters, demonstrating substantial equivalence to the predicate device.
Material Biocompatibility Testing	- Not a Sensitizer (for Closed Patch Sensitization)- Negligible Dermal Response (for Primary Dermal Irritation)- Non-cytotoxic (for Cytotoxicity – Agar Diffusion)	All materials (Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam) met the acceptance criteria for non-sensitization, negligible dermal irritation, and non-cytotoxicity (with one noted slight reactivity for Copolymer with Aliplast Foam, still deemed non-cytotoxic).

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

R&R Analysis & Cranial Shape Capture Accuracy Study: The document mentions "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" for the R&R analysis, and "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" for the accuracy study. Specific numeric sample sizes are not provided in the given text.
Data Provenance: The studies were conducted by Orthomerica Products, Inc., likely within their internal testing processes. The country of origin and whether the data was retrospective or prospective is not explicitly stated for these performance studies. However, as it's for a 510(k) submission, it would typically be prospective testing conducted by the manufacturer.

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

Not applicable for these engineering performance studies. The ground truth for the R&R analysis and Cranial Shape Capture Accuracy Study was established using "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions." This implies the "ground truth" was a precisely manufactured physical standard with measurable dimensions. No human expert interpretation was required.

4. Adjudication Method for the Test Set:

Not applicable. As the ground truth was based on physical standards with known dimensions, human adjudication was not part of these engineering performance tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-assisted diagnostic device, but rather a medical device (cranial orthosis) with a new 3D scanning method for fabrication. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, effectively. The performance studies (R&R and Cranial Shape Capture Accuracy) evaluated the Spectra 3D Scanner itself (an "algorithm only" component in the context of data capture) against known physical standards and compared its results to existing methods (casting and predicate devices). The scanner's output (3D head shape data) is then used in a manufacturing process, but the studies focused on the performance of the scanner as a standalone data capture tool.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the Repeatability and Reproducibility (R&R) Analysis and Cranial Shape Capture Accuracy Study, the ground truth was based on known dimensions of uniform shapes and a predefined cranial shape. This is a form of physical/reference standard.
For Material Biocompatibility Testing, the ground truth was established by standardized laboratory test procedures (e.g., scoring criteria for sensitization and irritation, cell reactivity grades for cytotoxicity).

8. The Sample Size for the Training Set:

Not explicitly stated in the provided text. As this is a 510(k) submission for a physical device with a new input method (scanner) rather than a complex AI model, the concept of a separate "training set" for the device itself (cranial orthosis) is likely not applicable in the same way it would be for a machine learning algorithm. The scanner itself would have internal calibration and testing procedures during its development, but these are not detailed here.

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

Not applicable as a separate "training set" for the device's clinical performance or the scanner's core functionality is not detailed as per the response to point 8. The "ground truth" for the performance studies shown here (R&R, Accuracy) was established through precisely manufactured physical standards.

Summary

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Public Health Service

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

September 18, 2015

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

Re: K151979

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: July 15, 2015 Received: July 17, 2015

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 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 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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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 同心

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) K151979

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 TrailOrlando, FL 32810
Telephone:	(407) 290-6592
Facsimile:	(407) 290-2419
Email:	dhooper@orthomerica.com
Date Prepared:	July 15th, 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 TrailOrlando, 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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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

트 STARband and STARlight, Cranial Orthosis, K151147

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VII. Summary of Technological Characteristics

The Spectra 3D Scanner 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 Spectra 3D Scanner is the focus of this submission and that change is indicated in Table 1 under the Approved 3-Dimensional Imaging Devices section.

Table 1 - Comparison of Predicate Device cleared in K151147 to the Proposed Device

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The STARband and STARlight Cranial Orthosis have already received FDA 510(k) clearance under K151147 for being manufactured from a handheld 3-dimensional imaging device that utilizes a LED structured light projector and a single camera to capture the 3D image (Rodin M4Dscan System). The Spectra Scanner utilizes the same technology as the FDA 510(k) cleared M4Dscan System of a LED structured light projector and takes continuous 2D images from triangulated positions with a single camera 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. Table 2 below is a summary of the performance testing conducted on the Spectra and the results obtained when compared to the casting method as well as previously cleared shape capture devices for the STARband and STARlight.

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Test	Test Method Summary	Results
Repeatability andReproducibility(R&R) Analysis	The purpose of this test is to analyzethe repeatability and reproducibility(components of precision) of theproposed shape capture device. Thedata obtained is compared to thecasting process and the predicatedevice.Utilized uniform shapes with knowndimensions that represent various sizesof pediatric patients between ages 3 to18 months of age. Associated testparameters include A-P and M-L.	The shape capture device passedthe acceptance criteria. Therelevancy of the test determinedsubstantial equivalence of theproposed shape capture device.
Cranial ShapeCapture AccuracyStudy	The purpose of this test is to analyzethe accuracy of the proposed shapecapture device. The data obtained iscompared to the casting process andthe predicate device.Utilized a representative cranial shapethat possesses a predefined shape withknown dimensions. Associatedparameters analyzed include A-P, M-L, P-D, various radius parameters,squareness, and flatness.	The shape capture device passedthe acceptance criteria for allparameters. The relevancy of thetest determined substantialequivalence of the proposed shapecapture device.

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 Spectra Scanner was evaluated for substantial equivalence. The scanner uses flashes of LED 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 Spectra Scanner yields a product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the scanner, the Spectra 3D Scanner 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)).

Feature	From K151147	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
Feature	From K151147	Proposed Device
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)
ProductDesign	Custom made cranial orthosis,approximately 6 to 10oz in weight.STARlight PRO weighs 12.5 to 18.5 oz.	Custom made cranial orthosis,approximately 6 to 10oz in weight.STARlight PRO weighs 12.5 to 18.5 oz.
Production	- 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- The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine	- 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- The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine
Approved 3-DimensionalImagingDevices	- STARscanner I- STARscanner II- Omega Scanner- scanGogh-II- 3dMDhead System- 3dMDcranial System- 3dMDflex System- SmartSoc System- M4DScan/BodyScan System	- STARscanner I- STARscanner II- Omega Scanner- scanGogh-II- 3dMDhead System- 3dMDcranial System- 3dMDflex System- SmartSoc System- M4DScan/BodyScan System- Spectra 3D Scanner
Testing	Repeatability and Reproducibility (R&R)Analysis- Utilized uniform shapes withknown dimensions that representvarious sizes of pediatric patientsbetween ages 3 to 18 months ofage- Compared proposed device to castand predicate device- Associated parameters includesA-P and M-L- Proposed device is substantiallyequivalent to predicate device	Repeatability and Reproducibility (R&R)Analysis- Utilized uniform shapes withknown dimensions that representvarious sizes of pediatric patientsbetween ages 3 to 18 months ofage- Compared proposed device to castand predicate device- Associated parameters includesA-P and M-L- Proposed device is substantiallyequivalent to predicate deviceCranial Shape Capture Accuracy Study
	Cranial Shape Capture Accuracy Study
Feature	From K151147	Proposed Device
	shape that possesses a predefined- shape 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 predefined- shape 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- Closed Patch Sensitization- Primary Dermal Irritation	Material Biocompatibility Testing- Cytotoxicity -Agar Diffusion- Closed Patch Sensitization- Primary Dermal Irritation