CaP Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, hydroxyapatite material intended for use in the filling, repair, reconstruction and auqmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas, with a surface area no larger than 25cm².

Device Description

Calcium Phosphate (CaP) Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in cranial-maxillo-facial surgical repair applications. At the time of use, the CaP product material is combined with the mixing liquid (U.S.P. Sodium Chloride, 0.9%) in the elastomeric mixing bulb, and is mixed, using a kneading technique, to form a paste. The paste can be administered to the treatment site by manual application, and be shaped in situ or into a desired form prior to implantation. After applying the paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the CaP Bone Substitute Material. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a typical AI/software device submission would.

This submission is for a material (bone substitute) and relies on demonstrating substantial equivalence to a previously approved predicate device, not on analytical or clinical performance metrics measured against specific acceptance criteria.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types for test/training sets, training set sample size, ground truth establishment) is not applicable to this type of submission as it's typically provided for diagnostic or AI-powered devices.

Here's an explanation based on the provided text, highlighting what is (and isn't) present:

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

Not Applicable. This submission is for a bone substitute material, not a diagnostic or AI-powered device. The basis for approval is "substantial equivalence" to a predicate device (α-BSM® Bone Substitute Material, K983009), meaning it is considered as safe and effective as a legally marketed device. The document does not describe quantitative acceptance criteria or performance metrics in terms of sensitivity, specificity, accuracy, or similar measures typically associated with AI/software device studies.
The comparison is based on "intended use," "material properties," and "product performance characteristics" being similar to the predicate device, and that "Differences between the CaP and a-BSM products do not raise any new questions of safety and effectiveness."

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. There is no "test set" in the context of an analytical or clinical performance study for an AI/software device described here. The submission relies on a comparison to a predicate device, which would have had its own original testing, but details of that testing are not in this document.

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 "test set" and thus no ground truth established by experts for such a set described in this document.

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

Not Applicable. No test set or adjudication method is 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:

Not Applicable. This is not an AI/software device. No MRMC study is mentioned.

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

Not Applicable. This is not an AI/software device. No standalone performance study is mentioned.

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

Not Applicable. As this is a material rather than a diagnostic or AI device, the "ground truth" concept in the context of a performance study does not apply. The inherent properties and safety/effectiveness of the material are assessed through established testing methods for biocompatibility, mechanical properties, and clinical performance (often by comparison to existing materials or through animal/human studies if new safety questions are raised). This document indicates "product performance characteristics" were compared to the predicate.

8. The sample size for the training set:

Not Applicable. No "training set" exists as this is not an AI/software device.

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

Not Applicable. No "training set" exists and thus no ground truth for it.

Summary

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OCT 2 4 2003

SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR:	ETEX Corporation
	38 Sidney Street, 3rd Floor
	Cambridge, MA 02139
	Phone: (617) 577-7270 x236
	Fax: (617) 577-7170
510(k) CONTACT:	Kristine Canavan
	Manager, Regulatory Affairs
TRADE NAME:	CaP Bone Substitute Material
COMMON NAME:	Bone Graft Material
	Bone Substitute Material
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	21 CFR 882.5300
	Methyl Methacrylate for Cranioplasty
PRODUCT CODE:	87 GXP
PREDICATE DEVICES:	a-BSM® Bone Substitute Material
	510(k) No.: K983009, ETEX Corporation

DEVICE DESCRIPTION:

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Image /page/1/Picture/0 description: The image shows handwritten text, including the alphanumeric string "K032307" and "20F2". Below these strings, the word "CONFIDENTIAL" is printed in bold and underlined. The text appears to be part of a document or label, possibly indicating a classification level or identification code.

paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

INDICATIONS FOR USE:

BASIS OF SUBSTANTIAL EQUIVALENCE:

CaP Bone Substitute Material is a synthetic bone graft substitute material substantially equivalent to α-BSM Bone Substitute Material (OMF). Both materials are provided sterile and as single patient, single use kits and are identical in intended use (i.e., cranio-maxillo-facial indications). CaP Bone Substitute Material is also similar to α-BSM Bone Substitute Material (OMF) in material properties and in product performance characteristics. Differences between the CaP and a-BSM products do not raise any new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

OCT 2 4 2003

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head and neck, represented by three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristine Canavan Manager, Regulatory Affairs ETEX Corporation University Park at MIT 38 Sidney Street Cambridge, MA 02139

Re: K032307

Trade Name: CaP Bone Substitute Material Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: July 24, 2003 Received: July 28, 2003

Dear Ms. Canavan:

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. Kristine Canavan

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 (301) 594-4659. 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 vours.

Sincerely yours,

Mark A. Millam

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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510(k) Number (if known)

K032307

Device Name: CaP Bone Substitute Material

Indications for Use:

CaP Bone Substitute Material is an implantable bone graft, that is a synthetic calcium phosphate hydroxyapatitic material intended to be implanted for use in the filling, repair, reconstruction and augmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas with a surface area no larger than 25cm .

Concurrence of CDRH, Office of Device Evaluation

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Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

for Mark N. Millburn

vision Sign-Off) Frision of General, Restorative and Neurological Devices

Number K03 2307

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).