The STARlight is intended for medical purposes for use in 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 original three devices from 510(k) K021207 are made of a plastic shell of 5/32" -1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. Since the original clearance a variation of the STARlight Bivalve has been released. It is identical in design to the STARlight Bivalve, but 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 its variation 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.

AI/ML Overview

The SEP 1 2 2008 510(k) summary provides details about the STARlight Cranial Orthosis, but it does not present a typical clinical study with acceptance criteria and device performance metrics in the way a diagnostic or AI-based device submission might. Instead, it focuses on demonstrating substantial equivalence to a predicate device and discussing changes to a related data acquisition system.

Therefore, it is not possible to fully complete the requested table and answer all questions as a traditional clinical study with acceptance criteria and measured device performance (e.g., sensitivity, specificity, accuracy) is not described for the STARlight device itself in this submission.

However, I can extract the information that is present regarding performance testing, particularly for the STARscanner™ Data Acquisition System.

Here's an attempt to answer the questions based on the provided document, highlighting what is not available:

Acceptance Criteria and Study Details for STARlight Cranial Orthosis

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing for the STARscanner™ Data Acquisition System, not the STARlight cranial orthosis itself. The "acceptance criteria" for the STARlight orthosis are implicitly related to its substantial equivalence to a predicate device and its continued successful use in clinical practice since 2002. For the STARscanner, the acceptance criterion was about achieving better accuracy than its predecessor.

Category	Acceptance Criteria	Reported Device Performance (STARscanner)
STARlight Orthosis	No explicit acceptance criteria for performance (e.g., clinical outcomes) are stated in this document. The device relies on demonstrating substantial equivalence to a predicate and continued successful clinical use.	Successful use in clinical practice since its original clearance in 2002. (This is a general statement, not a specific performance metric.)
STARscanner System	Accuracy of STARscanner II should be better than STARscanner I.	The accuracy of the STARscanner II was confirmed to be better than the STARscanner I.

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

STARscanner: Three different cylindrical shapes (100mm, 125mm, 150mm diameters) were scanned. Each shape was scanned five times at five different positions.
Data Provenance: Not explicitly stated, but implies laboratory testing of the scanner hardware. No information on human subject data provenance is provided for the orthosis's performance.

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

STARscanner: "Standard measurement systems statistical process control procedures were utilized" – this implies metrology experts, but no specific number or qualifications are given.
STARlight Orthosis: Not applicable as no such study is described for the orthosis's clinical performance.

4. Adjudication method for the test set:

STARscanner: Not explicitly stated beyond "Standard measurement systems statistical process control procedures were utilized."
STARlight Orthosis: Not applicable.

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 or AI-assisted study is described. The STARlight is a physical orthosis, and the STARscanner is a 3D scanner for head shape.

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

No standalone algorithm performance study is described for the STARlight orthosis. The STARscanner is a measurement device, and its accuracy was tested in a standalone manner (without a "human-in-the-loop" influencing its measurement accuracy directly).

7. The type of ground truth used:

STARscanner: The ground truth would be the known, precisely measured diameters of the three cylindrical shapes used in the testing.
STARlight Orthosis: Not applicable for a clinical performance study. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

Not applicable as the document describes a 510(k) submission for a physical device and a scanner, not a machine learning model.

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

Not applicable.

Summary

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SEP 1 2 2008

510(k) Summary

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

I Contact: David C. Kerr, Chief Executive Officer, Telephone: (949) 723-4500, Facsimile: (949) 723-4501
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
이 Summary Date - July 11, 2008
II. Submission Information
- 트 Type: Traditional 510(k) Submission
- 트 Proprietary Name: STARlight
- 트 Common Name: Cranial Orthosis
- 트 Classification: Class II (special controls); OAN; 21 CFR 882.5970
- 트 Classification Name: Cranial Orthosis
- 트 Predicate Device: STARlight, Cranial Orthosis, K021207
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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IV. Description of the Device

Statement of Indications for Use and Intended Use V.

Indications for Use:

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Intended Use:

The STARlight is designed to treat infants with abnormal head shapes from age 3 months 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 plagioccphaly, brachycephaly, and scaphocephaly. However, due to new minimally invasive surgical techniques for infants with craniosynostosis, post-surgical plagiocephaly, brachycephaly, and scaphocephaly are emerging as a growing patient group.

Craniosynostosis is caused by the premature fusion of one or more cranial sutures of the skull, causing the head to grow into an unusual shape. Some types of craniosynostosis have a clinical presentation similar to deformational (positional) plagiocephaly. Therefore in cases where the physician cannot make a definitive diagnosis, patients are referred to specialists such as neurosurgeons or cranio-facial surgeons. These specialists will order a test like a CT scan or MRI to confirm the diagnosis of craniosynostosis. If a baby has craniosynostosis, surgery is indicated to realign the plates of the skull and allow normal brain and skull growth to occur.

In general, the first year of life is the optimum time frame for surgical correction since infants are growing at such an accelerated rate during that time. No matter which surgical technique is used, the end result is a patient with no fused sutures. At this point the same principles that guide cranial remolding of deformational head shapes are applicable. In both deformational head shapes and post-surgical head shapes the STARlight is designed to maintain total contact over areas where growth is not desired, and allow for space over areas where growth is desired. The STARlight provides a pathway for the baby's head growth, directing it toward a more normal shape.

VI. Summary of Technological Characteristics

As mentioned previously, minor changes that were determined not to require 510K submission have been implemented via Orthomerica's Engineering Change Order process. These changes are illustrated in the following table. Furthermore, there are no technological characteristics changes required for the expansion in indications requested within this 510(k) submission. Therefore this table may also serve as a comparison of the proposed device as compared to the predicate device.

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Table 1

Comparison of Predicate Device cleared in 510(k) K021207 to the currently marketed device: Note: No changes will be made to the currently marketed device as a result of the proposed indications change in this submission

Feature	510K Cleared Device	Currently Marketed Device
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 voids overareas of depression or flattening to redirectcranial growth toward greater symmetry.
Materials	Material for all 3 designs:- 5/32" - 1/4" clear Surlyn or 1/8"- 7/32" Clear Co-Polyesterplastic shell	Material for original 3 designs:- 5/32" - 1/4" clear Surlyn or 1/8" -7/32" Clear Co-Polyester plasticshellMaterial for Bivalve variationOuter shell of 5/32" copolymerplasticAn inner liner of 1/2" pelitepolyethylene foam
	Closure for Bivalve designSliding/Overlap closure systemChicago screw (or similar) fortope sliding mechanism1" velcro strap1" chafe buckle91X speedy rivets	Closure for Bivalve designSliding/Overlap closure systemChicago screw (or similar) for topesliding mechanism1" velcro strap1" chafe buckle91X speedy rivets
	Closure for Side Opening design:1 ½" Velcro Strap1 ½" chafe buckle91X speedy rivetNylon washer	Closure for Side Opening design:1" Velcro Strap
	(no closure for full form design - justplastic shell)	(no closure for full form design - justplastic shell)
	Optional Cheek Pads1/8" Aliplast foam	Optional Cheek Pads1/8" Aliplast foam
Product Design	Custom made cranial remolding orthosis,approximately 7 to 10 ounces in weight,respective to the full form, side openingand bi-valved design.	Custom made cranial remolding orthosis,approximately 7 to 10 ounces in weight,respective to the full form, side opening andbi-valved design.
Production	Form orthosis from a positive mold of theinfants head; positive mold is formedfrom a negative cast mold or three-dimensional scan of the infants head.	Form orthosis from a positive mold of theinfants head; positive mold is formed from anegative cast mold or three-dimensionalscan of the infants head.

The two changes indicated on the table are the introduction of the bivalve design variation and the strap change on the STARlight Side Opening Design. The bivalve design is a simple material change. The STARlight Side Opening strap design was improved to eliminate the possibility for the metal rivet to contact the patient's skin.

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VII. Summary and Conclusions of Non-Clinical Performance Data

The STARlight cranial orthosis has been used successfully in clinical practice since its original clearance in 2002. The minor changes mentioned in the technical characteristics section above involved standard orthotic fabrication and materials that have undergone biocompatibility testing. However, the STARscanner™ Data Acquisition System used to capture the infant's head shape has had minor technical changes and with due diligence performance testing was conducted. The changes made to the STARscanner were to improve ease of use for the practitioner and to update components to the state of the art.

The accuracy, reproducibility, and repeatability of the STARscanner was evaluated by scanning three different cylindrical shapes( 100mm, 125mm, 150mm diameters) five times at five different positions within the scan volume. Standard measurement systems statistical process control procedures were utilized to evaluate STARscanner errors, error standard deviations, repeatability of multiple scans, and reproducibility of multiple scans at multiple locations within the scan volume. The accuracy of the STARscanner II was confirmed to be better than the STARscanner I.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

SEP 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081994

Trade/Device Name: STARlight® Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: July 11, 2008 Received: July 14, 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 vour 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.

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Page 2 - Mr. Alan T. Sandifer

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 procced to the market.

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 Pretmarket 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 M. Wilkerson

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

510K Number (if known): unknown KOSS 1994

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 K011954

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)).