Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros TCP Granules may, for example, be used for:

· supplementing autogenous cancellous bone
· supporting and stabilizing for guided bone regeneration, "GBR"
· filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy
· filling bone defects resulting from traumatic or pathological origin
· augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique)
· filling defects after explantation of dental implants
· filling small periodontal bone cavities as well as bi- and tri-furcations of teeth
· the reconstruction of alveolar defects prior to providing a prosthesis
· preparation of the implant bed (e.g. sinus lift)
· filling bone defects around dental implant after immediate placement into extraction sockets

Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.

Device Description

Ceros® TCP Granules are a synthetic, porous, osteoconductive, bioresorbable bone grafting material composed of beta-tricalcium phosphate, ß-TCP, [ß-C23]PO4]2] intended to fill, augment, or reconstruct bony defects in dental, oral or maxillofacial surgery. Ceros® TCP Granules are provided in volumes of 0.5, 1.0 and 2.5 g.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, Ceros® TCP Granules. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies. Therefore, the information requested in the prompt, such as acceptance criteria, detailed study designs, sample sizes for test and training sets, expert qualifications, and adjudication methods, is generally not present in a 510(k) summary focused on substantial equivalence.

Here's an explanation based on the document's content:

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

Acceptance Criteria: Not explicitly stated in terms of performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" for a 510(k) submission are typically met by demonstrating substantial equivalence to a predicate device, which involves showing similar intended use and technological characteristics.
Reported Device Performance: The document reports "Bench testing was performed to demonstrate conformance to ASTM F1088, including chemical composition by inductively coupled plasma and x-ray fluorescence, ß-TCP content by quantitative x-ray diffraction, and trace element analysis by inductively coupled plasma/mass spectroscopy. Testing was also performed to characterize physical characteristics including particle size and particle size distribution by optical image analysis and surface morphology by scanning electron microscopy. Dissolution testing was performed according to ISO 10993-14."
- This is not performance in a clinical sense against acceptance criteria, but rather verification of material properties and conformity to standards. Specific numerical results from these tests are not provided in this summary.

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

Not applicable / Not provided. A 510(k) submission for substantial equivalence generally does not involve a "test set" or clinical "data" in the sense of a performance study with patient data. The bench testing performed would use material samples, not patient data, and the sample size for these material tests is not specified.

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 / Not provided. Ground truth establishment by experts is relevant for studies involving human interpretation (e.g., imaging devices) or complex diagnoses. This is not the case for a bone graft material's substantial equivalence comparison based on physical and chemical properties.

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

Not applicable / Not provided. Adjudication methods are used to resolve discrepancies in expert interpretations in clinical performance studies, which are not detailed or required for this type of 510(k) submission.

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 / Not provided. Ceros® TCP Granules is a bone grafting material, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies or AI assistance are not relevant to this device.

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

Not applicable / Not provided. This is not an algorithm or AI device.

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

ASTM F1088 Standard, ISO 10993-14, and other material characterization standards. The "ground truth" here is compliance with established material and biocompatibility standards, determined through laboratory tests.

8. The sample size for the training set:

Not applicable / Not provided. There is no "training set" in the context of a substantial equivalence submission for a material device.

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

Not applicable / Not provided. As there's no training set, there's no establishment of ground truth for it.

In summary of the provided text for K101426 Ceros® TCP Granules:

The document outlines an FDA 510(k) summary aiming to demonstrate substantial equivalence to existing predicate devices (Synthes chronOS™ - B-TCP, Curasan AG Cerasorb® DENTAL, BioForm, Inc., Calcium Hydroxylapatite Implant).

The study proving the device meets acceptance criteria is the collection of bench tests demonstrating conformance to ASTM F1088 for chemical composition, ß-TCP content, trace elements, physical characteristics (particle size, distribution, morphology), and ISO 10993-14 for dissolution testing. The "acceptance criteria" here implicitly refer to meeting the specifications of these standards and having similar technological characteristics to the predicate devices. The details of these tests (e.g., exact sample size of material, specific results) are not provided in this summary, as is typical for 510(k) submissions.

Summary

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K101426 Ceros® TCP Granules

510(k) Summary

Mathys Ltd Ceros® TCP Granules

September 9, 2010

ADMINISTRATIVE INFORMATION

SEP 1 5 2010

Manufacturer Name:	Mathys Ltd
	Güterstrasse 5
	CH-2544 Bettlach
	Switzerland
Telephone:	+41 (0) 32 644 1 644
Fax:	+41 (0) 32 644 1 161
Official Contact:	Giancarlo Rizzoli, PhD
	Director Business Unit Biosurgery
Email:	giancarlo.rizzoli@mathysmedical.com
Representative/Consultant:	Linda K. Schulz, RDH, BSDH
	Kevin A. Thomas, PhD
	PaxMed International, LLC
	11234 El Camino Real, Suite 200
	San Diego, CA 92130
Telephone:	+1 (858) 792-1235
Fax:	+1 (858) 792-1236
email:	lschulz@paxmed.com
	kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:
Common Name:
Classification Regulations:
Product Code:
Classification Panel:
Reviewing Branch:

Ceros® TCP Granules Bone Grafting Material, Synthetic 21 CFR 872.3930 LYC Dental Products Panel Dental Devices Branch

INTENDED USE

{1}------------------------------------------------

510(k) Summary

K101426

Ceros® TCP Granules

· supplementing autogenous cancellous bone
· supporting and stabilizing for guided bone regeneration, "GBR"
· filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy
· filling bone defects resulting from traumatic or pathological origin

· augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique)

· filling defects after explantation of dental implants
· filling small periodontal bone cavities as well as bi- and tri-furcations of teeth
· the reconstruction of alveolar defects prior to providing a prosthesis
· preparation of the implant bed (e.g. sinus lift)
· filling bone defects around dental implant after immediate placement into extraction sockets

Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Mathys Ltd demonstrated that for the purposes of FDA's regulation of medical devices, Ceros TCP Granules are substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Synthes (USA) chronOS™ - B-TCP cleared under K053022,

Curasan AG Cerasorb® DENTAL and Cerasorb® M DENTAL cleared under K051443 BioForm, Inc., Calcium Hydroxylapatite Implant cleared under K030682.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject device is made of of B-TCP, [B-Ca3(PO4)2] conforming to ASTM F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. Predicate devices are made of B-TCP or a similar material, CaHA, with similar particle size, pore size and porosity to the subject device. Subject and predicate devices are packaged in similar materials and sterilized using similar methods.

Bench testing was performed to demonstrate conformance to ASTM F1088, including chemical composition by inductively coupled plasma and x-ray fluorescence, ß-TCP content by quantitative x-ray diffraction, and trace element analysis by inductively coupled plasma/mass spectroscopy. Testing was also performed to characterize physical characteristics including particle size and particle size distribution by optical image analysis and surface morphology by scanning electron microscopy. Dissolution testing was performed according to ISO 10993-14.

{2}------------------------------------------------

510(k) Summary

In summary, Ceros® TCP Granules have the following similarities to the predicate devices:

. have the same intended use,
. use the same operating principle,
incorporate the same basic design, .
incorporate the same or very similar materials, and .
have similar packaging and is sterilized using the same materials and processes. .

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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 features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mathys Limited C/O Ms. Linda Schulz PaxMed International LLC 11234 El Camino Real, Suite 200 San Diego, California 92130-8587

SEP 1 5 2010

Re: K101426

Trade/Device Name: Ceros® TCP Granules Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 16, 2010 Received: August 17, 2010

Dear Ms. Schulz:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{4}------------------------------------------------

Page 2- Ms. Schulz

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 requireme
You must comply with all the Aot's resuire You must comply with all the Act's requirements, including, but not limited to: registration
and listing (21 CFR Part 807): lebeling (21 CER D . . (2002): and listing (21 CFR Part 807); labeling (21 CFR Part 801); mot limited to: regist
(reporting of medical device related education (reporting of medical device-related adverse events) (21 CFR 803); 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 (21 CFR Part 820)
the Act): 21 CFR 1000-1050 the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),
please go to please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH) DRHOthees/ucm] 15809.htm for for for for for for please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalTroblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet Assis.
http://www.fda.org/Mali.clD http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hn for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary

K101426
Ceros®TCP Granules

Indications for Use

510(k) Number: K101426

Device Name: Ceros® TCP Granules

SEP 1 5 2010

Indications for Use:

· supplementing autogenous cancellous bone
· supporting and stabilizing for guided bone regeneration, "GBR"

· filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy

· filling bone defects resulting from traumatic or pathological origin

· augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique)

· filling defects after explantation of dental implants
• filling small periodontal bone cavities as well as bi- and tri-furcations of teeth
· the reconstruction of alveolar defects prior to providing a prosthesis
· preparation of the implant bed (e.g. sinus lift)

· filling bone defects around dental implant after immediate placement into extraction sockets

Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Turner

Page T of

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: حكومة الأمرات 2010)

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.