The STARband, STARlight, and St. Louis Band 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. 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 inage 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 last cleared in K180109 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 St. Louis Band (formally known as the O&P Bivalve Molding Helmet in K063395) was last cleared in K180109 by Orthomerica Products Inc. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro strap with chafe and loop for a secure fit.

The Cranial Comparison Utility (CCU) is a software component for a previously cleared shape capture method, the STARscanner Data Acquisition System, distributed by Orthomerica Products, Inc. The CCU is a separate software program that is designed to present specific measurements derived from a three-dimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.

The proposed addition is a new software component for a previously cleared shape capture method, the NetVirta SmartSoc Data Acquisition System, distributed by Orthomerica Products, Inc. The new software component is the Measurement Comparison Utility (MCU). The MCU is a separate software program, not used in manufacturing, which is designed to present specific measurements derived from a threedimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.

AI/ML Overview

The provided document describes a 510(k) premarket notification for Orthomerica Products Inc.'s cranial orthoses (STARband, STARlight, and St. Louis Band) with the addition of a new software component, the Measurement Comparison Utility (MCU). The acceptance criteria and supporting study details are primarily focused on the MCU Accuracy and Capabilities Study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the MCU's performance was evaluated against the predicate Cranial Comparison Utility (CCU) and manual/3D-CAD software measurements. The reported device performance is that the MCU was determined to be substantially equivalent to the predicate CCU.

Feature	Acceptance Criteria (Implicit)	Reported Device Performance
Measurement Accuracy & Capabilities	To be comparable to manual measurements and 3D-CAD software, and substantially equivalent to the predicate CCU in terms of model alignment, differential maps, calculations, and reporting.	MCU was determined to be substantially equivalent to the predicate CCU regarding accuracy of measurements and capabilities of model alignment, differential maps, calculations, and reporting.

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

Test Set Sample Size: The document states that the MCU Accuracy and Capabilities Study "Utilized representative cranial shapes that reflect symmetrical and asymmetrical cranial shapes." However, it does not specify the exact number (sample size) of these cranial shapes used in the test set.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It refers to "representative cranial shapes," which could be phantom models or de-identified patient data.

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

The document states that the MCU was "Compared... to manual measurements and 3D-CAD software." This implies that the ground truth for some measurements was established through manual methods and potentially by experts using 3D-CAD software. However, the document does not specify the number of experts used or their qualifications.

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth of the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in this submission. The focus was on the performance of the software (MCU) in comparison to established methods (manual measurements, 3D-CAD, and predicate software).

6. Standalone (Algorithm Only) Performance

A standalone performance study was performed. The "MCU Accuracy and Capabilities Study" evaluates the MCU software program itself, without human intervention in its measurement calculations or reporting. It compares the MCU's outputs to manual measurements and 3D-CAD software.

7. Type of Ground Truth Used

The ground truth used for the MCU Accuracy and Capabilities Study was:

Manual measurements
3D-CAD software measurements

This combination provided a reference for assessing the accuracy of the MCU's measurements and capabilities.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The MCU is described as a software component designed to present specific measurements from 3D digital models. It seems to function as a measurement and comparison tool rather than a machine learning algorithm that requires a traditional training set for model development in this context. The study focuses on its accuracy for processing existing 3D models.

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

Since a training set is not explicitly mentioned as relevant for this type of software (a measurement utility rather than a predictive model), the document does not describe how ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 27, 2021

Orthomerica Products Inc. Colton Carter Regulatory and Compliance Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810

Re: K203098

Trade/Device Name: STARband, STARlight, St. Louis Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: January 27, 2021 Received: January 28, 2021

Dear Colton Carter:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203098

Device Name

STARband, STARlight, and St. Louis Band Cranial Orthosis

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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AND THE A

11:58

510(k) Summary K203098

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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:	Colton Carter, Regulatory and Compliance Engineer
Address:	6333 North Orange Blossom TrailOrlando, FL 32810
Telephone:	(407) 290-6592
Facsimile:	(407) 290-2419
Email:	ccarter@orthomerica.com
Date:	April 27th, 2021

II. Submission Information

Type:	Traditional 510(k) Submission
Proprietary Name:	STARband®, STARlight®, and St. Louis Band
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

The STARband® and STARlight® redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured inage 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 last cleared in K180109 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.

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V. Indications for Use and Intended Use

Indications for Use:

The STARband®, STARlight®, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe nonsynostotic 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. 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.

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Intended Use:

The STARband®, STARlight®, and St. Louis Band 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®, STARlight®, or St. Louis Band for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARband®, STARlight®, and St. Louis Band 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 and Reference Devices

Predicate Device:

STARband and STARlight with Cranial Comparison Utility (CCU) K142141 ■

Reference Devices:

I St. Louis Band Cranial Orthosis - K161138
I STARband and STARlight with SmartSoc - K141842

VII. Summary of Technological Characteristics

The MCU proposed in this 510(k) is an added software program for a previously cleared shape capture method, the SmartSoc Data Acquisition System, that was cleared for use in the fabrication of the STARband , STARlight , and St. Louis Band Cranial Orthosis. The technological characteristics and the underlying principles of operation of the STARband , STARlight , and St. Louis Band Cranial Orthosis shall remain exactly the same. The inclusion of the MCU is the focus of this submission and the resulting change is indicated in Table 1 within the feature section Reporting Software. The addition of the accuracy and capabilities study conducted on the MCU is also indicated in the Testing section.

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Table 1.a – Comparison of Predicate Device cleared in K142141 to K203098

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Table 1.b – Comparison of Reference Device cleared in K161138 to K203098

Table 1.b - Comparison of Reference Device cleared in K161138 to K203098
Feature	From K161138	K203098
Intended Use	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.
Indications	The St. Louis Band is intended for medicalpurposes for use on infants from 3 to 18months of age, with moderate-to-severenon-synostotic positional plagiocephaly,including infants with plagiocephalic-,brachycephalic- and scaphocephalic-shaped heads by applying mild pressure toprominent regions of the infant's craniumin order to improve cranial symmetryand/or shape. This device is also indicatedfor adjunctive use for infants from 3 to 18months of age whose synostosis has beensurgically corrected, but who still havemoderate-to-severe cranial deformitiesincluding plagiocephalic-, brachycephalic-and scaphocephalic-shaped heads.	The St. Louis Band is intended for medicalpurposes for use on infants from 3 to 18months of age, with moderate-to-severenon-synostotic positional plagiocephaly,including infants with plagiocephalic-,brachycephalic- and scaphocephalic-shaped heads by applying mild pressure toprominent regions of the infant's craniumin order to improve cranial symmetryand/or shape. This device is also indicatedfor adjunctive use for infants from 3 to 18months of age whose synostosis has beensurgically corrected, but who still havemoderate-to-severe cranial deformitiesincluding plagiocephalic-, brachycephalic-and scaphocephalic-shaped heads.
Materials	St. Louis Band- Sliding/Overlap Closure System- Outer shell of 1/4" copolymer- plastic- An inner liner of 1/4" Aliplast- foam- Bi-Valve Closure- Sliding/Overlap Closure- System- 1" Velcro strap- 1" chafe buckle- Speedy rivets	St. Louis Band- Sliding/Overlap Closure System- Outer shell of 1/4" copolymer- plastic- An inner liner of 1/4" Aliplast- foam- Bi-Valve Closure- Sliding/Overlap Closure- System- 1" Velcro strap- 1" chafe buckle- Speedy rivets
Product Design	Custom made cranial orthosis,approximately 7 to 10oz in weight.	Custom made cranial orthosis,approximately 7 to 10oz in weight.
Production	Form orthosis from a positivemold of infant's head-Positive mold is formed basedupon measurements of theinfant's head taken by anapproved 3-dimensional imagingdevice from which a 3-dimensional image is made orfrom a traditional plaster cast	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
Feature	From K161138	K203098
	- The 3-dimensional image is used	- The 3-dimensional image is used
	to produce a positive mold using a	to produce a positive mold using a
	5-axis routing machine	5-axis routing machine
Approved 3-DimensionalImagingDevices	- STARscanner II- SmartSoc System	- STARscanner II- SmartSoc System
ReportingSoftware	None	- Measurement Comparison Utility(MCU)
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 deviceCranial Shape Capture Accuracy Study- Utilized a representative cranialshape 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 deviceMaterial Biocompatibility Testing- Cytotoxicity -Agar Diffusion- Closed Patch Sensitization- Primary Dermal Irritation	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- Utilized a representative cranialshape 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 deviceMCU Accuracy and Capabilities Study- Utilized representative cranialshapes that reflect symmetricaland asymmetrical cranial shapes- Compared MCU to manualmeasurements and 3D-CADsoftware- Accessed accuracy ofmeasurements and capabilities ofmodel alignment, differentialmaps, calculations and reporting

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The STARband , STARlight , and St. Louis Band Cranial Orthosis have previously received FDA 510(k) clearance with the SmartSoc® Data Acquisition System under K141842 for the STARband and STARlight® and under K161138 for the St. Louis Band. The MCU does not affect the operation of the SmartSoc Data Acquisition System and is not used for manufacturing of the STARband , STARlight, or St. Louis Band. The MCU is a separate software program designed to capture specific measurements derived from a 3D digital model of the patient's cranium. The STARband", STARlight", and St. Louis Band are the same devices as previously cleared with the predicate devices. The SmartSoc Data Acquisition System shape capture device has the same technological characteristics. Therefore, the STARband , STARlight , and St. Louis Band Cranial Orthosis are substantially equivalent to the predicate device.

The STARband , STARlight , and St. Louis Band are essentially the same Cranial Orthosis. The main difference between the STARband®, STARlight®, and St. Louis Band are the materials used to produce them. The STARband , STARlight , and St. Louis Band materials have been biocompatibility tested in previous submissions. Since the MCU is a separate software program not used in manufacturing, and the STARband® STARlight , and St. Louis Band materials are unchanged, the manufacturing processes remain identical and biocompatibility testing for this submission is leveraged from previous submissions.

Summary and Conclusions of Non-Clinical Performance Data VIII.

The MCU software program provides accurate information of 3D digital models from the SmartSoc Data Acquisition System. The accuracy and reliability of the SmartSoc Data Acquisition System has already been proven through accuracy analysis, as well as repeatability and reproducibility (R&R) studies. An accuracy and capability study was conducted on the MCU and was determined to be substantially equivalent to the predicate CCU.

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)).