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 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 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 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, specifically, the NetVirta SmartSoc™ System distributed by Orthomerica Products, Inc. This system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade digital camera with it's a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the STARband and STARlight Cranial Orthosis, specifically focusing on the addition of the NetVirta SmartSoc™ System for 3-dimensional shape capture. The document outlines non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for the SmartSoc System's performance in terms of cranial shape capture. Instead, it states that the conclusion of the studies was that the "Proposed device is substantially equivalent to predicate device." The studies were designed to compare the SmartSoc System against a cast and the predicate device (presumably the previously approved imaging devices for the STARband/STARlight).

However, the document does describe the types of tests performed and their general conclusions:

Acceptance Criteria (Implied)	Reported Device Performance and Conclusion
Repeatability and Reproducibility (R&R):	The SmartSoc System was evaluated for intra-system (repeatability) and inter-system (reproducibility) consistency in capturing head shapes.
Cranial Shape Capture Accuracy:	The SmartSoc System's ability to accurately capture known cranial shapes.
Material Biocompatibility (for the Orthosis itself, not the SmartSoc):	Materials used for the STARband and STARlight (Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam) must be biocompatible.
Safety of SmartSoc System (Light Source):	The SmartSoc System should be safe for infant use, specifically regarding its light source.

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

Sample Size for R&R and Accuracy Studies: The document states for R&R, it "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." For the Accuracy Study, it "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." Crucially, the exact number of these "uniform shapes" or "representative cranial shapes" (i.e., the n for the test set) is not specified. This is a significant omission from the provided summary.
Data Provenance: The studies appear to be in vitro or phantom-based studies ("uniform shapes," "representative cranial shape") rather than involving human subjects. Therefore, concerns about country of origin, retrospective/prospective, are not directly applicable in the way they would be for patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable or not specified. Ground truth appears to have been established by "known dimensions" of the uniform/representative shapes and comparison against physical casts. There's no mention of human expert involvement in defining the "truth" for these technical accuracy studies.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" for the technical studies on shape capture involved predefined, known physical dimensions and comparisons to physical casts, not subjective human assessment requiring adjudication.

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

MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies focus on the technical accuracy and consistency of the 3D capture system itself, not on how human readers/practitioners improve with or without AI assistance in diagnosis or treatment planning.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, the studies described (Repeatability and Reproducibility, Cranial Shape Capture Accuracy) assess the performance of the SmartSoc System itself (algorithm and hardware) in capturing shapes accurately and consistently, independent of human interpretation of the captured data for clinical decision-making. The "device" in this context is the SmartSoc system which captures the 3D shape, and its output (the 3D image) is then used to manufacture the orthosis. The studies verify the fidelity of this capture process.

7. Type of Ground Truth Used

Ground Truth Type:
- For the Repeatability and Reproducibility (R&R) Testing Analysis and Cranial Shape Capture Accuracy Study, the ground truth was based on known physical dimensions of "uniform shapes" or "representative cranial shapes" with "predefined shape with known dimensions." The system's output was also compared to "cast and predicate device." This suggests a physical phantom/model comparison with known measurements.

8. Sample Size for the Training Set

Training Set Sample Size: Not specified. This document is a 510(k) summary for a medical device (cranial orthosis) with a new imaging modality (SmartSoc System). It focuses on validation testing of the new modality. It does not provide details of any internal training data used by the SmartSoc system's algorithms, if applicable. The SmartSoc system uses "a customized non-repetitive printed pattern" on a flexible fabric sock; its internal algorithms for 3D reconstruction would have been developed and trained by NetVirta, but those details are not in this FDA summary.

9. How Ground Truth for the Training Set Was Established

Training Set Ground Truth: Not specified in this document for the reasons mentioned in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

October 6, 2014

Orthomerica Products, Inc. % David Kerr Chief Executive Officer 6333 N Orange Blossom Trail Orlando, Florida 32810

Re: K141842 Trade/Device Name: Starband, starlight Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: July 3, 2014 Received: July 8, 2014

Dear David Kerr,

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 - SVA

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) K141842

Device Name STARband and STARlight Cranial Orthosis

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
\u2612 Prescription Use (Part 21 CFR 801 Subpart D)	\u2610 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 Trail
	Orlando, 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 3, 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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IV. Description of Device/Modification

The STARband and STARlight product families as it was released in K140353 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.

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utilizes a consumer grade camera with a non-coherent light source for a flash, 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.

Predicate Devices VI.

STARband and Starlight, Cranial Orthosis, K140353

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VI. Summary of Technological Characteristics

The SmartSoc 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 SmartSoc 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 K140353	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.

Table 1 - Comparison of Predicate Device cleared in K140353 to the Proposed Device

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Materials	K141842 - STARband® and STARlight®
Material for STARband Side Opening design and STARband Bi-Valve design Outer shell of 5/32" copolymer plastic An inner liner of 1/2" Pelite polyethylene foam or 1/2" Aliplast foam	Material for STARband Side Opening design and STARband Bi-Valve design Outer shell of 5/32" copolymer plastic An inner liner of 1/2" Pelite polyethylene foam or 1/2" Aliplast foam
Material for STARlight Side Opening design and STARlight Bi-Valve design 5/32" - 1/4" clear Surlyn or 1/8" – 7/32" Clear Co-Polyester plastic shell	Material for STARlight Side Opening design and STARlight Bi-Valve design 5/32" - 1/4" clear Surlyn or 1/8" – 7/32" Clear Co-Polyester plastic shell
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 top sliding mechanism 1" Velcro strap 1" chafe buckle Speedy rivets	Closure for Bivalve design Sliding/Overlap closure system Chicago screw (or similar) for top sliding mechanism 1" Velcro strap 1" chafe buckle Speedy rivets
Closure for STARband Side Opening design 1 ½" Velcro Strap 1 ½" chafe buckle A Gap Block made from ½" firm Pelite polyethylene foam Large Flange, Blind Rivet	Closure for STARband Side Opening design 1 ½" Velcro Strap 1 ½" chafe buckle A Gap Block made from ½" firm Pelite polyethylene foam Large Flange, Blind Rivet
Closure for STARlight Side Opening design and the STARlight PRO design: 1" Velcro Strap	Closure for STARlight Side Opening design and the STARlight PRO design: 1" Velcro Strap

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Feature	From K140353	Proposed Device
	1" chafe buckleOptional tamper resistant strap(qty 2 for the STARlight PROdesign)	1" chafe buckleOptional 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	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-DimensionalImagingDevices	STARscanner ISTARscanner IIOmega ScannerscanGogh-II3dMDhead System3dMDcranial System3dMDflex System	STARscanner ISTARscanner IIOmega ScannerscanGogh-II3dMDhead System3dMDcranial System3dMDflex SystemSmartSoc System

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K141842 - STARband® and STARlight® Repeatability and Reproducibility (R&R) Repeatability and Reproducibility (R&R) Testing Analysis Analysis Utilized uniform shapes with Utilized uniform shapes with known dimensions that represent known dimensions that represent various sizes of pediatric patients various sizes of pediatric patients between ages 3 to 18 months of between 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 A-P and M-L Proposed device is substantially -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 shape that possesses a predefined shape that possesses a predefined shape with known dimensions shape with known dimensions -Compared proposed device to cast -Compared proposed device to cast and predicate device and predicate device Associated Coordinate Planes (A---Associated Coordinate Planes (A-P; M-L; P-D and various Radius P; M-L; P-D and various Radius Parameters; Squareness; Flatness) Parameters; Squareness; Flatness) Proposed device is substantially Proposed device is substantially -equivalent to predicate device equivalent to predicate device

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Feature	From K140353	Proposed 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

The STARband and STARlight Cranial Orthosis have already received FDA 510(k) clearance under K140353 for being manufactured from a 3-dimensional imaging device that utilizes a non-coherent light source and takes 2-dimensional (2D) images from triangulated positions for shape capture (3dMD Systems). The SmartSoc System also utilizes a non-coherent light source and takes 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.

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.

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Orthosis
Material	Test	Results	Conclusion
Surlyn	Closed PatchSensitization	A score of 0.00/0.00 (Test/Control)was given for both Incidence andSeverity in the 24 hour and 48 hourscoring 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 sampleexhibited 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 andSeverity in the 24 hour and 48 hourscoring 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 sampleexhibited 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 andSeverity in the 24 hour and 48 hourscoring 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 sampleexhibited slight reactivity (Grade 1).	Non-cytotoxic

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

Summary and Conclusions of Non-Clinical Performance Data VII.

The SmartSoc System was evaluated for safety and efficacy. The system uses a consumer grade camera and is safe to use on infants without any 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 SmartSoc System yields a safe and effective product that is substantially equivalent to the predicate device.4 With sufficient accuracy and no concerns with the safety of the system, the SmartSoc System was determined safe and effective 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)).