The STARlight is intended for medical purposes for use on infants from three 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 three to eighteen 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 STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or scan of the baby'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 modified further 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 Side Opening design, STARlight Bi-Valve design and the STARlight Cap design are all made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. 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.

The STARlight Cap design is made of the above plastic and contains no straps. 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 Bivalve 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 Ohio Willow Wood (OWW) Omega Scanner. Like the STARscanner Laser Data Acquisition system cleared with the STARlight (K021207 and K081994), the OWW Omega Scanner is a class 1 laser device. The OWW Omega Scanner is a handheld scanner consisting of two cameras, one laser, and eight LED lights.

AI/ML Overview

The provided text describes a 510(k) submission for a modification to the STARlight Cranial Orthosis, specifically the addition of the Ohio Willow Wood (OWW) Omega Scanner as a new shape capture method. The study focuses on demonstrating the safety and efficacy of this new scanner.

Here's an analysis of the acceptance criteria and study as per your request:

Acceptance Criteria and Reported Device Performance

The core of this submission is the evaluation of the OWW Omega Scanner. The acceptance criteria and reported performance relate to its accuracy, reproducibility, and repeatability.

Acceptance Criteria	Reported Device Performance
Safety: Meet Class 1 laser device standards	OWW Omega Scanner is a Class 1 laser device; inherently safe.
Efficacy: Accuracy	Met predetermined acceptance criteria for accuracy.
Efficacy: Reproducibility	Met predetermined acceptance criteria for reproducibility.
Efficacy: Repeatability	Met predetermined acceptance criteria for repeatability.

The document states, "The OWW Omega Scanner met the predetermined acceptance criteria and was found safe and effective for use with Cranial Orthoses." However, specific numerical thresholds for these criteria (e.g., a specific accuracy percentage, standard deviation for reproducibility) are not detailed in the provided text.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study appears to be a technical validation of the scanner's performance (accuracy, reproducibility, repeatability) rather than a clinical study requiring expert ground truth for diagnosis or outcome measurement. The "ground truth" for scanner performance would likely involve physical measurements from a reference object or repeated scans, not expert consensus on patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the study appears to be a technical validation of a measurement device, not a diagnostic or treatment outcome study requiring adjudication of expert interpretations.
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 done. This submission is for a physical measurement device (scanner) used to create an orthosis, not an AI-assisted diagnostic or interpretative tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The OWW Omega Scanner's performance (accuracy, reproducibility, repeatability) was evaluated in a standalone manner, meaning the scanner itself was tested for its ability to capture shape accurately and consistently. The results relate to the scanner's intrinsic technical performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of technical validation would typically involve a precisely known reference object or repeated measurements against a highly accurate standard. The document does not specify the exact nature of the ground truth, but it would not be expert consensus, pathology, or outcomes data in this context. It would be a physical reference standard or highly precise measurement method to compare the OWW Omega Scanner's output against.
The sample size for the training set:
- Not applicable. The OWW Omega Scanner is a commercial device being integrated into a workflow, not a machine learning algorithm that requires a training set in the conventional sense.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device in the context of this submission.

Summary

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K082445 pg 1 of 5

STARlight® Cranial Orthosis

510(k) Summary

OCT 3 1 2008

I. Applicant Information
- 트 Applicant's Name and Address: Orthomerica Products Inc. 505 318 Street. P.O. Box 2927, Newport Beach, CA 92659, Telephone: (949) 723-4500, Facsimile: (949) 723-4501

FDA Establishment Registration Number 1058152

에 Contact: David C. Kerr, Chief Executive Officer, Telephone: (949) 723-4500, Facsimile: (949) 723-4501
페 Submission Correspondent: Alan T. Sandifer, Director of Research and Development, 6333 North Orange Blossom Trail, Orlando, FL 32810, Telephone: (407) 290-6592, Facsimile: (407) 290-1303, asandifer@orthomerica.com
트 Summary Date - October 1, 2008
II. Submission Information
- Type: 510(k) Device Modification (Special)
- I Proprietary Name: STARlight
- Common Name: Cranial Orthosis
- 피 Classification: Class II (special controls): OAN; MVA: 21 CFR 882.5970
- 1 Classification Name: Cranial Orthosis
- I Predicate Device: STARlight, Cranial Orthosis, K081994
III. Manufacturing Site: 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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K0854945 pg 2 of 5

STARlight® Cranial Orthosis

IV. Description of Device

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Kärry 545 pg 3 of 5

Statement of Indications and Intended Use V.

Statement of Indications:

Intended Use:

The intended use is the same as it was for the STARlight in K081994; to correct head shape and proportion deformities. The STARlight is available by prescription only and is designed to treat infants with abnormal head shapes from age 3 to 18 months. 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. Recently 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.

Summary of Technological Characteristics VI.

The modification proposed is a change in how the infants head shape is captured; the technological characteristics and the underlying principles of operation of the STARlight cranial orthosis will remain exactly the same. This table illustrates that the device will in fact remain the same.

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K082445 P7 4 of 5
STARLight® Cranial Orthosis

	Note: No changes will be made to the currently marketed device as a result of the proposed changes in this submission
Feature	From K081994	Proposed Device
Indications	The STARlight is intended for medicalpurposes for use on infants from three to 18months of age, with moderate to severe non-synostotic positional plagiocephaly, includinginfants with plagiocephalic-, brachycephalic-and scaphocephalic-shaped heads by applyingmild pressure to prominent regions of theinfant's cranium in order to improve cranialsymmetry and/or shape. The device is alsoindicated for adjunctive use for infants fromthree to eighteen months of age whosesynostosis has been surgically corrected, butwho still have moderate to severe cranialdeformities including plagiocephalic-,brachycephalic-, and scaphocephalic-shapedheads.	The STARlight is intended for medicalpurposes for use on infants from three to 18months of age, with moderate to severe non-synostotic positional plagiocephaly, includinginfants with plagiocephalic-, brachycephalic-and scaphocephalic-shaped heads by applyingmild pressure to prominent regions of theinfant's cranium in order to improve cranialsymmetry and/or shape. The device is alsoindicated for adjunctive use for infants fromthree to eighteen months of age whosesynostosis has been surgically corrected, butwho still have moderate to severe cranialdeformities including plagiocephalic-,brachycephalic-, and scaphocephalic-shapedheads.
Mechanism	Applies pressure to the prominent regionsof the infants cranium in order to improvecranial symmetry and/or shape	Applies pressure to the prominent regionsof the infants cranium in order to improvecranial symmetry and/or shape
Materials	Material for STARlight Side Opening,STARlight Bi-Valve, STARlight Cap- 5/32" - 1/4" clear Surlyn or 1/8" –7/32" Clear Co-Polyester plasticshellMaterial for STARband Bivalve- Outer shell of 5/32" copolymerplastic- An inner liner of 1/2" pelitepolyethylene foamClosure for Bivalve design- Sliding/Overlap closure system- Chicago screw (or similar) for topsliding mechanism- 1" velcro strap- 1" chafe buckle- 91X speedy rivetsClosure for Side Opening design:- 1" Velcro Strap	Material for STARlight Side Opening,STARlight Bi-Valve, STARlight Cap- 5/32" - 1/4" clear Surlyn or 1/8" –7/32" Clear Co-Polyester plasticshellMaterial for STARband Bivalve- Outer shell of 5/32" copolymerplastic- An inner liner of 1/2" pelitepolyethylene foamClosure for Bivalve design- Sliding/Overlap closure system- Chicago screw (or similar) for topsliding mechanism- 1" velcro strap- 1" chafe buckle- 91X speedy rivetsClosure for Side Opening design:- 1" Velcro Strap
ProductDesign	Custom made cranial orthosis, approx 7 to10oz. in weight	Custom made cranial orthosis, approx 7 to10oz. in weight
Production	- Form orthosis from a positive mold of infant's head	- 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 from which a 3-dimensional image is made or from a traditional plaster cast	- 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	- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine

Table 1 – Comparison of Predicate Device cleared in K081994 to proposed device
Note: No changes will be made to the currently marketed device as a result of the proposed chan

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ﻟﺴﻨ

The inclusion of the OWW Omega Scanner is the focus of this submission and that change is indicated in the table under the production section.

Summary and Conclusions of Non-Clinical Performance Data VII.

The OWW Omega Scanner was evaluated for safety and efficacy. The primary safety concern is the laser. The STARscanner and the OWW Omega Scanner are both class 1 laser devices and as such are inherently safe without eye protection under all normal operating conditions. The effectiveness of the OWW Omega Scanner was evaluated through accuracy, reproducibility, and repeatability testing. The OWW Omega Scanner met the predetermined acceptance criteria and was found safe and effective for use with Cranial Orthoses.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle symbol, with its wings forming three distinct lines.

Public Health Service

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CARTER COMPANIE PAR BALL A LEAST A LEAST AND AND

Orthomerica Products, Inc. % Mr. Alan T. Sandifer Director of Research and Development 6333 North Orange Blossom Trail Orlando, Florida 32810

Re: K082945

Trade/Device Name: STARlight® Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: October 1, 2008 Received: October 2, 2008

Dear Mr. Sandifer:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

OCT 3 1 2008

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Page 2 - Mr. Alan T. Sandifer

Comments of the contribution of the securities and with the results of the

るというとしているというとなってきていました。このことです。です。

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

に出版がある。これらなお気をさせたりますが、いつくなるのです。その時間ができるというという

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark W. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

The state the contribution of the security of the county of the county of the may

510K Number (if known): KO82945

Device Name: STARlight®

Indications for Use:

Prescription Use X (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 CDRH. Office of Device Evaluation (ODE) (Division Sign-Off)

Division of General, Restorative. and Neurological Devices

510(k) Number

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)).