Cerasorb ORTHO in granular form is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.

Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.

Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and substituted by vital, natural bone.

Device Description

Cerasorb ORTHO is a porous resorbable bone void filler for the repair of bony defects. Chemically the material consists of pure phase Beta-Tricalciumphosphate, as described in the ASTM F 1088 - 87 (reapproved 1992). It is an osteoconductive implant with interconnected porosity. The implant is provided sterile in granular form, granular sizes being 500 - 1000um or 1000 - 2000 um.

When Cerasorb ORTHO is placed in the defect site with direct contact with the viable host bone, it guides the three-dimensional regeneration of bone. As the Cerasorb ORTHO granules resorbs, newly formed bone grows into the space previously occupied by the granular Beta-Tricalciumphosphate material. Cerasorb ORTHO was shown to have 90% or greater resorption in animal studies and was also shown to resorb well clinically.

AI/ML Overview

Here's an analysis of the provided text regarding the Cerasorb ORTHO Synthetic Bone Void Filler, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the subject device. As such, information typically found in a standalone clinical trial report (like detailed sample sizes for test sets, ground truth methodology for training, MRMC studies, or detailed performance metrics against specific acceptance criteria) is generally not present here. The performance is largely inferred from its similarity to the predicate device and general material properties.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for Cerasorb ORTHO are implicitly derived from its substantial equivalence to the predicate device, Vitoss™ Scaffold Synthetic. The following table summarizes the key performance attributes that indicate equivalence rather than explicit numerical acceptance criteria.

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Cerasorb ORTHO)
Material Composition: Must be β-Tricalciumphosphate.	β-Tricalciumphosphate, Ca₃(PO₄)₂. Its chemical composition is consistent with ASTM F 1088 - 87 (reapproved 1992).
Structure: Porous, with interconnected porosity.	Interconnective porosity. Micropores >0<80µm. Consistent with previous predicate.
Osteoconductivity: Must support bone growth.	Osteoconductive (+) - Guides three-dimensional regeneration of bone.
Resorption: Must resorb over time to be replaced by bone.	Resorption (+) - Gradually resorbed and substituted by vital, natural bone. 90% or greater resorption shown in animal studies and also shown to resorb well clinically.
Bone Remodeling: Must allow for bone remodeling.	Bone remodeling (+) - As granules resorb, newly formed bone grows into the space.
Mechanical Properties: Non-weight-bearing.	Granules have no weight-bearing capacity. Execution of osteosynthetic measures eventually necessary.
Sterility: Sterile, single-use.	Sterile (gamma radiation), single use only.
Biocompatibility: Must be biocompatible.	Established. (Implicitly demonstrated by material composition and predicate equivalence, animal studies).
Intended Use/Indication: Bone void filler.	Bone void filler for voids or gaps not intrinsic to stability, indicated for filling bone defects caused by surgery, trauma, or degenerative processes. Same as predicate.
Patient Population: Patients with bone voids/gaps.	Patients with bone voids or gaps, caused by surgery, trauma or degeneration. Similar to predicate, with degeneration added as a cause.
Anatomical Location: Skeletal system.	Skeletal system (extremities, spine, pelvis). Same as predicate.
Labeling Consistency: Warnings, precautions, etc.	Same intended use, contraindications, warnings, precautions and adverse events as predicate.

Study Details Proving Device Meets Acceptance Criteria

2. Sample Sizes and Data Provenance:
* Test Set Sample Size: Not explicitly stated for human clinical data in this 510(k) summary. The document mentions "animal studies" for resorption and "resorb well clinically," but does not provide details about the number of animals or human patients evaluated in these clinical observations/studies.
* Data Provenance: The document states "animal studies" and "resorb well clinically". No specific country of origin is mentioned for these informal clinical observations. The 510(k) process relies heavily on pre-market data, often including literature review, in-vitro testing, and animal studies, rather than large-scale prospective human trials for demonstrating substantial equivalence. The predicate device (Vitoss™ Scaffold Synthetic) would have its own data provenance, which is not detailed here.

3. Number of Experts and Qualifications for Ground Truth:
* This is not applicable as the document does not describe a study involving expert assessment or interpretation of results in the way it would for an AI/diagnostic device. The "ground truth" for material properties like osteoconductivity and resorption is established through scientific testing and observation, not expert consensus on images or clinical classifications.

4. Adjudication Method for the Test Set:
* Not applicable as this is not a study requiring expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation or other tasks where human readers' performance is being measured and compared, often with and without AI assistance. This document describes a bone void filler material, not a diagnostic device.

6. Standalone (Algorithm Only) Performance Study:
* No, a standalone algorithm performance study was not done. This is not an algorithm-based device.

7. Type of Ground Truth Used:
* The "ground truth" for this device's performance characteristics (e.g., osteoconductivity, resorption, biocompatibility) is based on:
* Material Science Principles: Properties of β-Tricalciumphosphate.
* Animal Studies: For resorption rates and bone formation ("90% or greater resorption in animal studies").
* Clinical Observations/Experience: "resorb well clinically." (Informal, not detailed).
* ASTM Standards: Compliance with ASTM F 1088 - 87 for material composition.
* Performance characteristics of the legally marketed predicate device.

8. Sample Size for the Training Set:
* Not applicable. There is no AI model or algorithm being "trained" for this medical device. The "training" in a broad sense would be the cumulative scientific knowledge and experimental data on β-Tricalciumphosphate and bone regeneration.

9. How the Ground Truth for the Training Set Was Established:
* Not applicable, as there is no training set in the context of an AI device. The foundational knowledge used to develop and validate the device's properties comes from established scientific literature, previous animal studies, and known characteristics of similar materials (like the predicate device).

Summary

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MAR 1 8 2002

Image /page/0/Picture/1 description: The image shows the word "curasan" in a bold, sans-serif font. Above the word, there is a handwritten code "KO14156" and "10F3". The word "curasan" is the main focus of the image, and the handwritten codes appear to be annotations or identifiers.

510 (K) Summary Cerasorb ORTHO Synthetic Bone Void Filler

Submitted by

Lindigstrasse 4, D - 63801 Kleinostheim, Germany curasan AG Contact person: Dr. Rolf Kaufmann, Head of Regulatory Affairs Tel.: ++49 -- 6027 -- 468653 Fax: ++49 - 6027 -- 468633 E - mail zul-3@curasan.de

CommERCIALIZATION GROUP, LLC KENNETH WEST Registered U. S. agent ECHNOLOGY SOPHIA DRIVE SAN' HILL, NC 27514 USA 116 4PEL 1.6748

Prepared:

Curasan Ab

	Subject Device	Predicate Device
Trade name	Cerasorb ORTHO	Vitoss™ Scaffold Synthetic
Common Name	Bone void filler	Bone void filler
Classification Name	Filler, β-TricalciumphosphatePreformed granules	Filler, β-TricalciumphosphatePreformed granules

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Comparison To Predicate Tabulated Form

. . . . .

K014156
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: :

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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	Cerasorb ORTHO	Vitoss™ Scaffold
Indication / intended use	Bone void filler, synthetic	Bone void filler, synthetic
Patient population	Patients with bone voids orgaps, caused by surgery,trauma or degeneration	Patients with bone voids orgaps, caused by surgery ortrauma
Anatomical location	skeletal system (extremities,spine, pelvis)	skeletal system (extremities,spine, pelvis)
Labeling	Same intended use,contraindications, warnings,precautions and adverseevents as predicate	see enclosure
Chemical composition of thematerial	β-Tricalciumphosphate,Ca3(PO4)2	β-Tricalciumphosphate,Ca3(PO4)2
Structure of the material	Interconnective porosity	Trabecular structure similarto cancellous bone
Porosity of the material	Micropores >0<80µm	Pore size 1 - 1000 μm
Performance Osteoconductivity Resorption Bone remodeling Mechanical properties	+++Granules have no weight-bearing capacity. Execution ofosteosynthetic measureseventually necessary	++Does not import mechanicalstrength to surgical site
Sterility	Sterile (gamma radiation)Single use only	Sterile (gamma radiation)Single use only
Biocompatibility	Established	Established
Presentation	Granules, sizes:500 - 1000 µm	Morsels (1-4mm sizes) andblocks (9x23mm cylinder)

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Device description

Intended use

Cerasorb ORTHO in granular form is intended for use as a bone vold filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.

Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.

Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and substituted by vital, natural bone.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right and has a sleek, modern design. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2002

Curasan AG c/o Arrowsmith-Lowe Consulting, Inc. 5 Eagle Creek Road P.O. Box 3148 Ruidoso, New Mexico 88355 Attn: Thomas Arrowsmith-Lowe

Re: K014156

Cerasorb ORTHO Regulatory Class: unclassified Product Code: MQV Dated: December 18, 2001 Received: December 19, 2001

Dear Dr. Arrowsmith-Lowe:

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

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Page 2 - Dr. Thomas Arrowsmith-Lowe:

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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Mark N Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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Page 1 of I

510(k) Number (if known): K014156

Cerasorb ORTHO Device Name:

Indications For Use: Intended use

Cerasorb ORTHO in granular form is intended for use as a bone void filler for volds or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process, Cerasorb ORTHO many of wou intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.

Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.

Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and replaced with new bone.

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

Concurrence of CDRH, Office of CDevice Evaluation (ODE)

for Mark A. Millman

(Division Sign-Off) Division of General, Restorative and Neurological Device

510(k) Number -

(Optional Format 3-10-98)

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.