Cranioplastic® is a self-curing, methylmethacrylate (MMA) based acrylic resin, for repairing cranial defects. The following modifications are being made: A change is being made to the formulation of the liquid and powder components of the acrylic cement and the Instructions for Use (IFU) is being updated.

AI/ML Overview

This section describes how the device meets the acceptance criteria. It should be noted that this device, Cranioplastic®, is a medical device (methyl methacrylate for cranioplasty) and the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to pre-existing devices rather than on a detailed clinical study with specific acceptance criteria in the way one might evaluate a diagnostic AI algorithm. Therefore, the information typically requested for AI/software-based devices, such as sample sizes for test/training sets, expert qualifications, adjudication methods, and MRMC studies, is not applicable or available for this type of submission.

Here's an analysis based on the provided text, addressing the points where information is available:

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

For a material like Cranioplastic®, "acceptance criteria" are typically related to material properties and performance characteristics that demonstrate equivalence to predicate devices, rather than a single numerical performance metric (like accuracy or sensitivity) against a clinical outcome.

Acceptance Criteria (Implied by Substantial Equivalence Basis)	Reported Device Performance (Summary of Equivalence)
Technological Characteristics:	Demonstrated similarity in:
- Chemical Composition	(Not explicitly detailed, but implied as similar to predicates)
- Material Properties	(Not explicitly detailed, but implied as similar to predicates)
- Performance Characteristics	(Not explicitly detailed, but implied as similar to predicates)
- Manufacture	(Not explicitly detailed, but implied as similar to predicates)
- Packaging	(Not explicitly detailed, but implied as similar to predicates)
- Sterilization	(Not explicitly detailed, but implied as similar to predicates)
Intended Use:	"repair of cranial defects" (Identical to predicates)
Indications for Use:	"repair of cranial defects" (Identical to predicates)

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets its acceptance criteria is the 510(k) premarket notification process itself. The submission argues for substantial equivalence to legally marketed predicate devices, specifically Cranioplastic® (K873689) and SmartSet GMV Endurance Gentamicin Bone Cement (K033382).

The basis for substantial equivalence is explicitly stated as its "similarity in terms of technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization)" to the predicate devices. The modifications made were a change to the formulation of the liquid and powder components and an update to the Instructions for Use (IFU). The FDA's issuance of the 510(k) clearance signifies their agreement that this substantial equivalence has been demonstrated.

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

Not applicable. This is a material science and engineering equivalence submission, not a human reader or AI performance study. There isn't a "test set" in the context of clinical images or patient data. The "testing" involved demonstrating that the modified formulation's properties are comparable to the predicate devices and suitable for the intended use.

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. Ground truth, in the AI/radiology sense, is not relevant here. The "ground truth" for this device is its material characteristics and its functional performance in repairing cranial defects, which is evaluated through engineering and chemical testing, and clinical use history of similar predicate devices.

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

Not applicable. There is no test set in the clinical evaluation sense, and therefore no adjudication method for human readers.

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-assisted diagnostic device.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" in this context would be established through:

Material specifications and testing: Chemical composition analysis, mechanical property testing (e.g., strength, setting time), biocompatibility testing. These are compared against established standards for medical implants and against the properties of the predicate devices.
Clinical history of predicate devices: The long-standing safe and effective use of the predicate devices for cranial repair provides the "ground truth" that methyl methacrylate is an appropriate material for this application. The sponsor demonstrates that their modified device maintains these established characteristics.

8. The sample size for the training set

Not applicable. There is no training set in the context of machine learning.

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

Not applicable. There is no training set.

Summary

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K071791/

510K SUMMARY SECTION 4

NAME OF FIRM:	JUL 30 2007Codman & Shurtleff, Inc.325 Paramount DriveRaynhamMA 02767-0350
510(k) CONTACT:	Rachel CreaneSenior Regulatory Affairs Specialist
TRADE NAME:	Cranioplastic®
COMMON NAME:	Methyl Methacrylate (MMA)
CLASSIFICATION:	Class II; 21 CFR 882.5300
DEVICE PRODUCT CODE:	GXP
SUBSTANTIALLY EQUIVALENTDEVICES:	Cranioplastic®(K873689)SmartSet GMV Endurance Gentamicin Bone Cement(K033382)

DEVICE DESCRIPTION:

Cranioplastic® is a self-curing, methylmethacrylate (MMA) based acrylic resin, for repairing cranial defects. The following modifications are being made:

A change is being made to the formulation of the liquid and powder components of the acrylic cement and the Instructions for Use (IFU) is being updated.

INTENDED USE AND INDICATIONS:

Cranioplastic® is indicated for the repair of cranial defects.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of Cranioplastic® to the identified predicate devices is demonstrated by its similarity in terms of technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization) to Cranioplastic® (K873689) and SmartSet GMV Endurance Gentamicin Bone Cement (K033382).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is oriented to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2007

Codman & Shurtleff, Inc. % Ms. Rachel Creane Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767-0350

Re: K071791

Trade/Device Name: Cranioplastic® Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: June 28, 2007 Received: July 02, 2007

Dear Ms. Creane:

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 -- Ms. Rachel Creane

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

Sincerely yours,

Barbara Buehrig

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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SECTION 5 INDICATIONS STATEMENT

510(k) Number (if known):

Device Name: Cranioplastic®

Indications for Use:

Cranioplastic® is indicated for the repair of cranial defects.

Prescription Use ਮ (Part 21 CFR 801.Subpart D)

Over-The Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare buchun

Division of General, Restorative, and Neurological Devices

510(k) Number K071791

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).