The Craniocephalic Custom Remolding Orthosis (CCRO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.

Device Description

The CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape during natural infant growth. Appropriate for infants 3 to 18 months, the CCRO consists of a polypropylene (or copolymer, or polyethylene as warranted), outer shell with multiple inner polypropylene foam liners of various thicknesses, and an optional support strap. The foam liners and outer plastic shell, are vacuum formed over a positive mold developed from an impression of the infant's head. The orthosis allows applicable areas for the infant heads fill in during normal infant growth, to achieve appropriate cranial symmetry.

AI/ML Overview

The provided text is a 510(k) summary for the Craniocephalic Custom Remolding Orthosis (CCRO). It focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a new drug or a novel AI software.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as the submission relies on demonstrating similarity to existing, legally marketed devices.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent:

1. A table of acceptance criteria and the reported device performance

This document does not present quantitative acceptance criteria or a formal study comparing performance against such criteria. The "performance" claimed is based on the device's design and mechanism of action being similar to predicate devices, with an assertion that it will perform "as-well-as, if not better than" its counterparts.

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (as stated in document)
(Not explicitly stated as quantitative criteria for a study)	"Equivalent if not an enhancement in effectiveness for patient care"
(Not explicitly stated as quantitative criteria for a study)	"Will perform as-well-as, if not better than its helmet counterparts to address treatment of nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads."
(Implicit: Improvement in cranial symmetry for specific conditions)	"Allows an infants cranium to improve in symmetry and/or shape during natural infant growth."
(Implicit: Applicability for certain age range)	"Appropriate for infants 3 to 18 months."
(Implicit: Treatment of specified conditions)	"Applicable for moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No formal test set or clinical study data is presented in this 510(k) summary for performance validation. The submission relies on comparative claims to predicate devices.
Data Provenance: Not applicable. No clinical data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of a test set with ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set or an adjudication method.

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

Not applicable. This is not an AI/software device. There is no MRMC study or AI assistance involved.

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

Not applicable. This is a physical medical device (cranial orthosis), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is discussed as no performance study data is presented. The "truth" in this context is the FDA's determination of substantial equivalence based on comparison to predicate devices, materials, and intended use.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. As above, this is a physical device.

Summary regarding the provided document:

The K070694 submission is a 510(k) notification for a Craniocephalic Custom Remolding Orthosis (CCRO). The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (LLUMC K023572, Ballert K030669, Clarren K003035).

The justification for equivalence is based on:

Similar materials: All devices are made of similar materials widely used in orthotics.
Similar fabrication processes: All use vacuum forming, similar casting/impression techniques, and mold creation/modification.
Similar mechanism of action: All function in the same way to improve cranial symmetry during natural infant growth.
Similar intended use: All are for improving cranial symmetry in infants 3-18 months with moderate to severe nonsynostotic positional plagiocephaly (including plagiocephalic, brachycephalic, and scaphocephalic heads).

The "acceptance criteria" here are implicit and relate to the FDA's regulatory requirements for 510(k) clearance, primarily showing that the device is as safe and effective as a legally marketed predicate device. There is no mention of a formal clinical performance study with specific quantitative acceptance criteria, sample sizes, expert ground truth, or adjudication methods in this summary. The submission argues that the CCRO is "equivalent if not an enhancement in effectiveness" by design and comparison, rather than through new clinical performance data.

Summary

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K070694

510(k) Summary (I.A.W. 21 CFR 807.87(h)

Applicant Information

Owner:	Mike Miner1098 E Mutton HollowKaysville, Utah 84037(801) 547-0369
Contact:	(As above)
Date:	SEP 10 2007
Device Name and Classification
Proprietary name:	Craniocephalic Custom Remolding Orthosis
Common name:	Cranial Helmet
Classification name:	Cranial Orthosis
Predicate Device:	LLUMC K023572, Ballert K030669, Clarren K003035

Device Description

'he CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape during natural infant growth. Appropriate for infants 3 to 18 months, the CCRO consists of a polypropylene (or copolymer, or polyethylene as warranted), outer shell with multiple inner polypropylene foam liners of various thicknesses, and an optional support strap. The foam liners and outer plastic shell, are vacuum formed over a positive mold developed from an impression of the infant's head.

The orthosis allows applicable areas for the infant heads fill in during normal infant growth, to achieve appropriate cranial symmetry.

Intended Use

The CCRO is appropriate for improving cranial symmetry in infants from 3 to 18 months. The Craniocephalic Custom Remolding Orthosis (CCRO) is applicable for moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads.

Comparison to Pediatric Device

The devices are made of the same materials, (all of which are also all widely used in the orthotic industry). The devices are also all fabricated through vacuum forming process, utilize the same csting/impression taking style, the same mold creation and modification regimens, and all function the ame way.

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With the Craniocephalic Custom Remolding Orthtosis, the multipule liner system allows for increased precision and accuracy in adjustments during the ongoing follow up protocols.

These comparisons are presented in the comparison table found in the executive summary.

Conclusions

In comparison of the CCRO to its counterpart predicates, it is believed that the Craniocephalic Custom Remolding Orthtosis is equivalent if not an enhancement in effectiveness for patient care, and will perform as-well-as, if not better than its helmet counterparts to address treatment of nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic - shaped heads.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or faces, depicted with flowing, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2007

Mr. Mike Miner 1098 East Mutton Hollow Kaysville, UT 84037

Re: K070694

Trade/Device Name: Cranial Custom Remodeling Orthosis (CCRO) Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: June 12, 2007 Received: June 12, 2007

Dear Mr. Miner:

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. 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

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Page 2 - Mr. Mike Miner

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 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely your

Mark 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

Indications for Use

510(k) Number (if known): _K070694 ___ Device Name: ___Craniocephalic Custom Remolding Orthosis -----------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for Use:

Prescription Use required Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

меского полнение поставления по пристеменные пристикам семетрические мести по полнение котории словенности полнение стоимание станиемовника композии местические местиче

DL
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number / K070694

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)).