The CAMLab Cranial Orthosis Helmet is intended 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. The device 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.

Device Description

The initial geometry of the patient is acquired from either laser scanned measurements using the BioScanner (a.k.a. Polhemus Fastscan handheld laser scanner) or via traditional casting methods. If a cast is taken, the cast will be scanned with the BioScanner as well.

The resulting three dimensional model along with a digital order form and any other pertinent information is then sent to BioSculptor Corporation via email or secured internet application. Utilizing this information, the BioSculptor CAD/CAM system will then create a positive mold representative of the patient scan. This positive model will then be used to create the orthosis.

Each orthosis consist of a plastic outer shell, a foam inner shell, a strap and fastener to secure the orthosis. The practitioner modifies the orthosis to achieve an accurate fit and monitors the progress to ensure that no adverse effects occur.

AI/ML Overview

The provided text is a 510(k) Summary for the CAMLab Cranial Orthosis Helmet. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device.

Therefore, the information you've requested about acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text. The 510(k) summary explicitly states that the safety and effectiveness summary has been prepared pursuant to the requirement for 510(k) summaries, which primarily aims to show equivalence.

However, I can extract the comparison table that highlights the equivalence between the CAMLab Cranial Orthosis Helmet and its predicate device, the STARband Orthomerica. This table implicitly represents the "acceptance criteria" not as novel, quantifiable performance metrics achieved by a new study, but as alignment with the established characteristics and performance of the legally marketed predicate device.

Here's a breakdown of what can be extracted and what is not present:

Acceptance Criteria and Performance (Based on Substantial Equivalence to Predicate)

Feature / Criteria	Predicate Device (Orthomerica STARband Cranial Orthosis K011350)	CAMLab Cranial Orthosis Helmet (This submission)
Indications for Use	Treatment of abnormal infant head shape (positional/deformational plagiocephaly)	Treatment of abnormal infant head shape (positional/deformational plagiocephaly)
Clinical Population	Infants age 3-18 months	Infants age 3-18 months
Materials	Copolymer plastic/closed cell polyethylene foam/Velcro strap	Copolymer plastic/closed cell polyethylene foam/Velcro strap
Daily Wear Time	23 hrs./day	23 hrs./day
Average Time to Effectiveness (patients age 3-7 months)	2-4 months	2-4 months
Contradictions for Use	Craniosynostosis/Hydrocephalus	Craniosynostosis/Hydrocephalus
Method of Manufacture	Custom from mold using a laser scanner, CAD/CAM system and 5-axis router machine	Custom from mold using a laser scanner, CAD/CAM system and 5-axis router machine

Explanation of "Acceptance Criteria" in this context: The "acceptance criteria" here are implicitly met by demonstrating that the new device shares the same indications for use, clinical population, materials, wear time, average time to effectiveness, contraindications, and manufacturing method as the legally marketed predicate device. The FDA's issuance of the 510(k) clearance signifies that the CAMLab Cranial Orthosis Helmet is "substantially equivalent" to the predicate, meaning it is as safe and effective.

Information Not Available in the Provided Document:

Sample sizes used for the test set and the data provenance: Not applicable or not detailed for a novel performance study. The submission relies on equivalence to a predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no independent performance study described with a test set requiring expert ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable. The document does not describe such a study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical cranial orthosis, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there's no independent performance study described.
The sample size for the training set: Not applicable, as this is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense. The "training" in the context of manufacturing refers to the CAD/CAM system's design capabilities, based on established practices, rather than a data-driven model.
How the ground truth for the training set was established: Not applicable for the reasons stated above.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It does not contain independent performance study data, acceptance criteria, or details regarding ground truth establishment that would be present in a submission for a novel device or an AI/ML product. The "study" proving the device meets the acceptance criteria is the comparison presented in the "Substantial Equivalence Comparison Table," which shows alignment with the predicate device's established characteristics and performance.

Summary

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510(k) Summary CAMLab Cranial Orthosis Helmet BioSculptor Corporation

K081787. '/2

JAN 2 7 2009

510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807,92(a).

807.92(a)(1)

Submitter Information

BioSculptor Corporation 2480 West 82nd Street, #8 Bay 1A Hialeah, Florida 33016

(305) 556-5815 Phone: Fax: (305) 823-8304 Contact: Mark Mazloff

Date: June 18, 2008

807.92(a)(2)

Proprietary Name: Common or Usual Name: Regulation Number: Classification Name(s):

Classification Code: OAN Secondary Classification Code: MVA

807.92(a)(3)

Predicated Device(s)

Cranial Orthosis Helmet

Orthosis, Cranial Laser Scan

21 CFR 882.5970

Cranial Orthosis

CAMLab Cranial Orthosis Helmet

STARband Orthomerica

K011350

Classified under 21 CFR 882.570

Additional substantial equivalence information is provided in the following Substantial Equivalence Comparison Table.

807.92(a)(4)

Device Description

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K081787. 2/2

510(k) Summary CAMLab Cranial Orthosis Helmet BioSculptor Corporation

807.92(a)(5)

Intended Use(s)

807.92(a)(6)

	Orthomerica STARbandCranial OrthosisK011350	CAMLab CranialOrthosis Helmet(This submission)
Indications for Use	Treatment of abnormalinfant head shape(positional/deformationalplagiocephaly)	Treatment of abnormalinfant head shape(positional/deformationalplagiocephaly)
Materials	Copolymer plastic/closedcell polyethylenefoam/Velcro strap	Copolymer plastic/closedcell polyethylenefoam/Velcro strap
Clinical Population	Infants age 3-18 months	Infants age 3-18 months
Daily Wear Time	23 hrs./day	23 hrs./day
Average Time to Effectiveness(patients age 3-7 months)	2-4 months	2-4 months
Contradictions for Use	Craniosynostosis/Hydrocephalus	Craniosynostosis/Hydrocephalus
Method of Manufacture	Custom from mold usinga laser scanner,CAD/CAM system and5-axis router machine	Custom from mold usinga laser scanner,CAD/CAM system and5-axis router machine

Substantial Equivalence Comparison Table

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2-7 2009

BioSculptor Corporation % Mr. Mark Mazloff 2480 West 82nd Street, #8 Hialeah, Florida 33016

Re: K081787

Trade/Device Name: CAMLab Cranial Orthosis Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: January 6, 2009 Received: January 7, 2009

Dear Mr. Mazloff:

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.

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Page 2 - Mr. Mark Mazloff

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.

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 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 N Mulkerson

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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INDICATIONS FOR USE STATEMENT

Applicant:

BioSculptor Corporation

(08)78 510(k) Number (if known):

Device Name:

CAMLab Cranial Orthosis Helmet

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V Over the Counter

(Per 21 CFR,801.109)

(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Confidential Information BioSculptor Corporation

Page 4 v. 6188.

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)).