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

Device Description

The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape 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 STARlight provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the 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 STARlight product family as it was released in K090587 are essentially still the same devices. 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. The STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. 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 STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap 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 shape capture method. specifically the scanGogh-11" by Vorum Research, Inc. This scanner uses one laser, either Class 1 or Class 2 depending on the option, and one camera to capture shape data. The Class I laser option of the scanGogh-II is as safe as other scanner devices previously cleared for the STARlight and will not require any extra safety precautions. The Class 2 laser option is safe to use on infant patients when used in conjunction with eye protection. The Class I laser option of the scanGogh-II shall be the recommended option for scanning infants. If the Class 2 option of the scanGogh-II is used, the infant should wear eye protection as instructed in the proposed labeling.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the STARlight® Cranial Orthosis, based on the provided text:

Acceptance Criteria and Device Performance

The core of this submission is the addition of a new shape capture method, the scanGogh-II, for the STARlight Cranial Orthosis. The acceptance criteria and performance are tied to the accuracy of this new scanner compared to existing methods.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Requirement (Implicit)	Reported Device Performance (scanGogh-II vs. Cast)
Cranial Shape Capture Accuracy Study	Maintain or improve accuracy compared to Cast method.	Pass (performed superior for all listed metrics)
Proximal Radius	Substantially equivalent/superior to cast.	Pass
Proximal Anterior Radius	Substantially equivalent/superior to cast.	Pass
Anterior Radius	Substantially equivalent/superior to cast.	Pass
Anterior Posterior Length	Substantially equivalent/superior to cast.	Pass
M-L Width Anterior	Substantially equivalent/superior to cast.	Pass
M-L Width Posterior	Substantially equivalent/superior to cast.	Pass
Posterior Panel Flatness	Substantially equivalent/superior to cast.	Pass
Lateral Panel Flatness	Substantially equivalent/superior to cast.	Pass
L-P Panels Square	Substantially equivalent/superior to cast.	Pass
Medial Panels Flatness	Substantially equivalent/superior to cast.	Pass
M-P Panels Squares	Substantially equivalent/superior to cast.	Pass
Repeatability and Reproducibility (R&R) Analysis	Acceptable level of repeatability and reproducibility.	Determined to be acceptable.
Laser Safety (Class 1 Laser option)	Safe for infant use without extra protection.	Safe.
Laser Safety (Class 2 Laser option)	Safe for infant use with proper eye protection.	Safe when used with eye protection.
Eye Shield Fit Assessment (for Class 2 Laser option)	Proper fit, complete coverage, effective protection.	Pass (acceptable fit, completely covered the eye).
Material Biocompatibility (Surlyn, Copolymer + Pelite, Copolymer + Aliplast)	Non-sensitizing, negligible dermal response, non-cytotoxic.	All materials passed tests as "Not a Sensitizer," "Negligible Dermal Response," and "Non-cytotoxic" (with one "slight reactivity" for Copolymer + Aliplast in Cytotoxicity).

Study Information

2. Sample size used for the test set and the data provenance

Sample Size:
- For the Cranial Shape Capture Accuracy Study: "a representative cranial shape that possesses a predefined shape with known dimensions" was utilized. This implies a single, standardized phantom or model rather than a dataset of patient scans.
- For the Repeatability and Reproducibility (R&R) Analysis: "uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" were utilized. No specific number is given, but it implies a set of phantoms or models.
- For the Eye Shield Fit Assessment: "infants" were assessed. No specific number is provided.
Data Provenance: The studies appear to be prospective in nature, conducted specifically for this submission. The "country of origin" for this data is not explicitly stated, but given the company's location (Orlando, FL) and FDA submission, it's presumed to be within the US or compliant with US standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for the Cranial Shape Capture Accuracy Study and R&R Analysis was established using "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions". This suggests that the ground truth was based on pre-defined, precisely measured physical models or phantoms, rather than relying on human expert consensus or clinical data. Therefore, no human experts were explicitly mentioned as establishing the ground truth for the performance testing of the scanner itself.

4. Adjudication method for the test set

Not applicable as the ground truth was established by known physical dimensions of models/phantoms, not by human review requiring adjudication.

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 MRMC comparative effectiveness study was performed or needed. This device is a cranial orthosis and a new scanning method. There is no "human reader" component in the sense of image interpretation for diagnosis that would benefit from AI assistance. The scanning method replaces manual measurement or other digital scanning methods.

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

Yes, the performance of the scanGogh-II (the algorithm/hardware for shape capture) was evaluated in a standalone manner against known physical dimensions without a human-in-the-loop performance scenario in the context of the Cranial Shape Capture Accuracy Study and R&R Analysis.

7. The type of ground truth used

Known physical dimensions of uniform and representative cranial shapes/phantoms. This is a form of engineered or precisely measured ground truth.

8. The sample size for the training set

The document does not describe any "training set" in the context of machine learning or AI. This submission is for a physical medical device (cranial orthosis) and a new shape capture tool. The scanGogh-II is a scanner, not an AI algorithm that would typically require a training set to learn.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary

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K133250

JAN 16 2014 STARlight® Cranial Orthosis

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:	October 16, 2013

II. Submission Information

Type:	Traditional 510(k) Submission
Proprietary Name:	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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There have been changes made to the STARlight Side Opening and the STARlight PRO. The modifications involve the changing of the closure straps for the STARlight Side Opening and the STARlight PRO. The closure strap is a chafe and loop system similar to those used in the Bi-Valve designs. The STARlight Side Opening and the STARlight PRO also have the option of having a tamper resistant Velcro strap for the closure system. These were minor and determined to not require a 510(k) submission. Table 1 illustrates the minor differences between the cleared device (K090587) and the devices as it currently is marketed.

V. Statement of Indications and Intended Use

Statement of Indications:

Intended Use:

The STARlight is designed to treat infants with abnormal head shapes from age 3 months to 18 months and is available by prescription only. Since growth is the driving factor in head shape correction, the infants wear the STARlight for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARlight has 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

STARlight, Cranial Orthosis, K090587 ■
. STARband, Cranial Orthosis, K124023

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VI. Summary of Technological Characteristics

The modification proposed is the use of an additional tool which can be used to capture the infant's head shape; the technological characteristics and the underlying principles of operation of the STARlight Cranial Orthosis will remain exactly the same. The other modifications include the removal of the STARlight Cap, the addition of a chafe buckle and an optional tamper resistant strap for the STARlight Side Opening and STARlight PRO designs. This table illustrates that the device will in fact remain the same.

Feature	From K090587	Proposed Device
Intended Use	Maintains total contact over areas of bossing or protrusion and creates voids over areas of depression or flattening to redirect cranial growth toward greater symmetry.	Maintains total contact over areas of bossing or protrusion and creates voids over areas of depression or flattening to redirect cranial growth toward greater symmetry.
Materials	Material for STARlight Side Opening.STARlight Bi-Valve, STARlight Cap5/32" - 1/4" clear Surlyn or 1/8" –7/32" Clear Co-Polyester plastic shell	Material for STARlight Side Opening andSTARlight Bi-Valve5/32" - 1/4" clear Surlyn or 1/8" –7/32" Clear Co-Polyester plastic shell
	Material for STARlight PRO1/4" - 3/8" clear Surlyn	Material for STARlight PRO1/4" - 3/8" clear Surlyn
	Material for STARband BivalveOuter shell of 5/32" copolymer plasticAn inner liner of 1/2" pelite polyethylene foam	Material for STARband BivalveOuter shell of 5/32" copolymer plasticAn inner liner of 1/2" pelite polyethylene foam
	Closure for Bivalve designSliding/Overlap closure systemChicago screw (or similar) for top sliding mechanism1" Velcro strap1" chafe buckleSpeedy rivets	Closure for Bivalve designSliding/Overlap closure systemChicago screw (or similar) for top sliding mechanism1" Velcro strap1" chafe buckleSpeedy rivets
	Closure for STARlight Side Openingdesign and the STARlight PRO design:1" Velcro Strap(qty 2 for the STARlight PRO design)	Closure for STARlight Side Openingdesign and the STARlight PRO design:1" Velcro Strap1" chafe buckleOptional tamper resistant strap(qty 2 for the STARlight PRO design)
Product Design	Custom made cranial orthosis,approximately 7 to 10oz in weight.STARlight PRO weighs 12.5 to 18.5 oz.	Custom made cranial orthosis,approximately 7 to 10oz in weight.STARlight PRO weighs 12.5 to 18.5 oz.
Feature	From K090587	Proposed Device
Production	- Form orthosis from a positive mold of infant's head- Positive mold is formed based upon measurements of the infant's head taken by the STARscanner, or the OWW Omega Scanner from which a 3-dimensional image is made or from a traditional plaster cast- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine	- Form orthosis from a positive mold of infant's head- Positive mold is formed based upon measurements of the infant's head taken by the STARscanner, the OWW Omega Scanner, or the scanGogh-II from which a 3-dimensional image is made or from a traditional plaster cast- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine
Testing	Repeatability and Reproducibility (R&R) Analysis- Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age- Compared proposed device to cast and predicate device- Associated parameters includes A-P and M-L- Proposed device is substantially equivalent to predicate deviceMaterial Biocompatibility Testing- Cytotoxicity -Agar Diffusion- Closed Patch Sensitization- Primary Dermal Irritation	Repeatability and Reproducibility (R&R) Analysis- Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age- Compared proposed device (scanGogh-II) to cast and predicate device- Associated parameters includes A-P and M-L- Proposed device is substantially equivalent to predicate deviceCranial Shape Capture Accuracy Study- Utilized a representative cranial shape that possesses a predefined shape with known dimensions- Compared proposed device (scanGogh-II) to cast and predicate device- Associated Coordinate Planes (A-P; M-L: P-D and various Radius Parameters; Squareness: Flatness)- Proposed device is substantially equivalent to predicate deviceEye Shield Fit Assessment- A specific eye shield would properly fit infants- Assess coverage, fit and effectiveness- Proposed eye shields pass the assessment and provide safe and effective protectionMaterial Biocompatibility Testing- Cytotoxicity -Agar Diffusion- Closed Patch Sensitization- Primary Dermal Irritation

Table 1 – Comparison of Predicate Device cleared in K090587 to the Proposed Device

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and the state of the same of the same

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The inclusion of the scanGogh-II is the focus of this submission and that change is indicated in Table 1 under the production section. Additional testing was performed on the scanGogh-II to ensure substantial equivalence, that change is indicated in Table 1 under the testing section. Table 2 shows the additional accuracy testing performed and the comparison results of the scanGogh-II. The term Pass within Table 2 indicates the scanGogh-11 accuracy performed superior to the Cast method.

ProximalRadius	ProximalAnteriorRadius	AnteriorRadius	AnteriorPosteriorLength	M-LWidthAnterior	M-LWidthPosterior	PosteriorPanelFlatness	LateralPanelFlatness	L-PPanelsSquare	MedialPanelsFlatness	M-PPanelsSquares
scanGogh-IIvs. CastCranial HeadShape	Pass	Pass	Pass	Pass	Pass	Pass	Pass	Pass	Pass	Pass

Table 2 - scanGogh-11 Accuracy Comparison Summary
---------------------------------------------------	--

The scanGogh-II has already received FDA clearance for the STARband Cranial Orthosis (K124023) which is also held by Orthomerica Products, Inc. The STARband and the STARlight are essentially the same device. They have the same indications for use and undergo the same manufacturing process. The main difference between the STARlight and the STARband 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. Given that the technological characteristics of the STARband are the same as the proposed device, these devices are substantially equivalent.

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

Biocompatibility Test Results

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STARlight® Cranial Orthosis

	Copolymer with Primary Dermal	Primary Irritation Index: 0.00	Negligible Dermal
Aliplast Foam	Irritation		Response
Copolymer with Cytotoxicity -		Cell culture treated with test sample	Non-cvtotoxic
Aliplast Foam	Agar Diffusion	exhibited slight reactivity (Grade 1)

VII. Summary and Conclusions of Non-Clinical Performance Data

The scanGogh-II was evaluated for safety and efficacy. The primary safety concern is the laser. The scanner uses either a Class 1 Laser or a Class 2 Laser. The Class 1 Laser version of the scanGogh-II is safe to use on infants without any extra protection. The Class 2 Laser version is safe as long as the patient has proper eye protection. An Eye Shield Fit Assessment was performed. The Eye Shield Fit Assessment showed the eye shields were an acceptable fit for infants as they completely covered the eye. Therefore, eye shields provide safe and effective protection of the infant's eye during scanning. 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 scanGogh-II yields a safe and effective product that is substantially equivalent to the predicate device. With sufficient accuracy and proper laser safety procedures, the scanGogh-II was determined safe and effective for scanning infants for STARlight Cranial Orthosis.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

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

January 16, 2014

Orthoamerica Products, Inc. c/o Mr. David Elooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando. FL 32810

Re: K133250

Trade/Device Name: STARlight Cranial Orthosis Regulation Number: 21 CER 882.5970 · Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN. MVA Dated: October 16, 2013 Received: October 22, 2013

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 mav, 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 is 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

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Page 2 - Mr. David Hooper

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

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

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

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

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

Sincerely yours.

Joyce M. Whang -S

for Carlos L. Peña, Ph.D., M.S. 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): K133250

Device Name: STARlight Cranial Orthosis

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

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)).