This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is 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.

The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

Device Description

The DOC Band-PostOp consists of a plastic band, a fastener with Velcro strap, and, in some models, a strut to hold height at the top of the head.

AI/ML Overview

The provided text (KD42385) is a 510(k) summary for the DOC Band-PostOp™. It primarily focuses on demonstrating substantial equivalence to a predicate device (the DOC Band, K964992) rather than providing detailed acceptance criteria and a comprehensive study report in the format requested.

Therefore, much of the requested information regarding specific acceptance criteria, study design parameters (sample sizes, expert qualifications, adjudication methods), and detailed performance metrics is not explicitly available within this document. The document states that "clinical data demonstrate that the DOC Band-PostOp, as indicated for use post-operatively, in the absence of craniosynostosis, is as safe and effective as the DOC Band." However, it does not provide the specifics of that clinical data.

Here’s an attempt to answer based on the provided text, with clear indications where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device is as safe as the predicate device (DOC Band).	"Clinical data demonstrate that the DOC Band-PostOp... is as safe and effective as the DOC Band." (Specific metrics or thresholds for safety are not provided in this summary. Safety is implied through substantial equivalence to a previously cleared device, which would have established its safety.)
Effectiveness: Device is as effective as the predicate device (DOC Band) in improving cranial symmetry or shape for the specified indications.	"Clinical data demonstrate that the DOC Band-PostOp... is as safe and effective as the DOC Band." (Specific metrics or thresholds for effectiveness, such as percentage improvement in cranial symmetry or specific measurements like Cephalic Index, are not provided. Effectiveness is implied through substantial equivalence to a previously cleared device, which would have established its effectiveness.)
Intended Use: Device performs its intended function.	The device has the "same intended uses." Its function is to "apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape." (Performance is inferred from the statement of substantial equivalence rather than explicit new performance data.)
Biocompatibility: Device materials are biocompatible.	"Yes." (Confirmed to be biocompatible, same as predicate device. No specific test results or acceptance criteria for biocompatibility are detailed in this summary.)

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

Sample Size for Test Set: Not specified in the provided document. The document refers to "clinical data" but does not detail the size or characteristics of the test population.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the summary. For a device like a cranial orthosis, "ground truth" would likely be derived from anthropometric measurements, clinical assessments by pediatric specialists, or imaging. However, the summary does not detail the methodology for establishing such ground truth for any clinical study mentioned.

4. Adjudication method for the test set

This information is not provided in the summary, as a specific "test set" with adjudication is not described.

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. This device is a physical medical device (cranial orthosis), not an AI/software device that involves human readers or AI assistance in interpretation. Therefore, an MRMC study with AI assistance is not applicable and was not performed.

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

No. This device is a physical medical device; it does not involve algorithms or standalone performance in the context of AI.

7. The type of ground truth used

The document implies that "clinical data" supported the claim of safety and effectiveness. For a cranial orthosis, ground truth regarding effectiveness would typically come from anthropometric measurements (e.g., cranial index, diagonal measurements) and clinical assessments of head shape by medical professionals. However, the specific methodology or the nature of this "ground truth" for the supporting data is not detailed in this summary.

8. The sample size for the training set

This information is not provided as a "training set" is not relevant for this type of physical medical device and the nature of the substantial equivalence pathway presented.

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

This information is not provided as a "training set" is not relevant for this type of physical medical device.

Summary

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KD42385

DEC 17 2004

510(k) SUMMARY

Cranial Technologies, Inc.'s DOC Band Post-Op™

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Cranial Technologies, Inc. 1395 West Auto Drive Tempe, AZ 85284 Phone: (480) 505-1840 Facsimile: (480) 505-1844

Timothy R. Littlefield Contact Person:

August 5, 2004 Date Prepared:

Name of Device and Name/Address of Sponsor

DOC Band-PostOp™

Cranial Technologies, Inc. 1395 West Auto Drive Tempe, AZ 85284 Phone: (480) 505-1840 Facsimile: (480) 505-1844

Common or Usual Name

Cranial Remodeling Band, Cranial Helmet, Molding Helmet

Classification Name

Cranial Orthosis, 21 C.F.R. § 882.5970

Predicate Devices

Cranial Technologies, Inc.'s DOC Band (K964992)

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Intended Use / Indications for Use

The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

Technological Characteristics

The DOC Band-PostOp consists of a plastic band, a fastener with Velcro strap, and, in some models, a strut to hold height at the top of the head.

Substantial Equivalence

The DOC Band-PostOp has the same intended uses, technological characteristics, and principles of operation as its predicate device, the cleared DOC Band, and very similar indications. The new indication for use does not raise any new questions of safety or effectiveness. Furthermore, clinical data demonstrate that the DOC Band-PostOp, as indicated for use post-operatively, in the absence of craniosynostosis, is as safe and effective as the DOC Band. Thus, the DOC Band-PostOp is substantially equivalent. A summary of substantial equivalence between the devices is provided in the following Substantial Equivalence Chart.

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CRANIAL TECHNOLOGIES, INC.'S DOC BAND-POSTOP SUBSTANTIAL EQUIVALENCE CHART

	DOC Band-PostOp™	DOC Band®(K964992)
Intended Use	The device is intended for medicalpurposes to apply pressure toprominent regions of an infant'scranium to improve cranialsymmetry or shape.	The device is intended for medicalpurposes to apply pressure toprominent regions of an infant'scranium to improve cranial symmetryor shape.
Indications for Use	Indicated "for adjunctive use ininfants from three to eighteenmonths of age whose synostosishas been surgically corrected, butwho still have moderate to severecranial deformities includingplagiocephalic-, brachycephalic-,or scaphocephalic-shaped heads."	Indicated "to treat infants from threeto eighteen months of age withmoderate to severe non-synostoticpositional plagiocephaly, includingplagiocephalic-, brachycephalic-,scaphocephalic-shaped heads."
Contraindications	Infants with craniosynostosis orhydrocephalus.	Infants with craniosynostosis orhydrocephalus.
TechnologicalCharacteristics	Band (constructed of USP ClassVI semi-rigid polypropylene-polyethylene copolymer outersurface thermobonded to amedium density polyethylenefoam (Pelite) inner lining)Plastic and Steel Fastener withVelcro StrapStrut (in Bi-Cal design only)Elastic Bands (in Bi-Cal designonly)	Band constructed of USP Class VIsemi-rigid polypropylene-polyethylenecopolymer outer surfacethermobonded to a medium densitypolyethylene foam (Pelite) innerlining)Plastic and Steel Fastener with VelcroStrapElastic Bands (in Bi-Cal design only)
Biocompatibility	Yes.	Yes.
Sterilization	Not provided sterile.	Not provided sterile.
Standards withwhich the DeviceComplies	No performance standards apply.The device complies with FDA'sspecial controls for cranialorthosis devices.	No performance standards apply. Thedevice complies with FDA's specialcontrols for cranial orthosis devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of three human profiles facing right, with flowing lines representing movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Mr. Timothy R. Littlefield, MS Vice President Cranial Technologies, Inc. 1395 West Auto Drive Tempe, Arizona 85284

Re: K042385

Trade/Device Name: DOC Band-PostOp™ Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MVA Dated: December 9, 2004 Received: December 10, 2004

Dear Mr. Littlefield:

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. Timothy R. Littlefield, MS

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Alan Watts

Celia M. Witten, Ph.D., M.D. 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

510(k) Number (if known): K042385

Device Name: DOC Band-PostOp™

Indications for Use:

The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 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

Page

Division of General, Restorative. and Neurological Devices

510(k) Number 1(012365

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)).