Synthacer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Synthacer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.

Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.

Device Description

Synthacer® Calcium Salt Bone Void Filler is a porous calcium phosphate bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameter averages 600um and the average porosity is 60 - 80%. The implant is provided sterile in block. cylinder, morsel and ball form. Synthacer® is composed of a calcium phosphate ceramic which is at least 95% pure hydroxyapatite Cas(PO4)3OH.

Synthacer® promotes three-dimensional regeneration of bone in the defect site into which it is implanted. When Synthacer® is placed in direct contact with viable host bone, new bone growth occurs in apposition to the calcium phosphate surfaces of the implant. As the Synthacer® is resorbed, bone grows into the space previously occupied by the scaffold the implant provides. Synthacer® is radiopaque.

Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for yoids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. Syntricer® should not be used to treat large defects that in the surgeon's opinion would not heal spontaneously. Pore diameter averages 600um and the average porosity is 60 -80%. Syntricer® is composed of a calcium phosphate ceramic which is at least 95% pure tricalcium phosphate Ca3(PO4)2. The implant is provided sterile in block, cylinder, morsel and ball form.

Syntricer® is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void, the Syntricer® will slowly resorb and be replaced with bone over time during the healing process.

AI/ML Overview

The provided document is a 510(k) summary for the Synthacer® and Syntricer® Calcium Salt Bone Void Fillers, dated June 23, 2005. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study with defined metrics.

Therefore, an acceptance criteria table and detailed study information as requested cannot be fully extracted because the document does not contain this type of data for the described device. The submission relies on substantial equivalence to predicate devices, implying that the safety and effectiveness are established by showing the new devices are as safe and effective as existing legally marketed devices.

Based on the provided text, here's what can be stated regarding the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific acceptance criteria with corresponding performance metrics for the Synthacer® and Syntricer® devices. The submission is based on demonstrating "substantial equivalence" to predicate devices, meaning it argues that the new devices are as safe and effective as already approved devices, rather than meeting predefined quantitative performance thresholds from a de novo study.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No mention of a "test set" or a study designed to gather data on the device's performance against specific metrics. The substantial equivalence argument relies on comparing the technological characteristics and intended use to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. No "ground truth" establishment is described for a test set, as no such performance study is detailed in this 510(k) summary.

4. Adjudication Method 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, and the effect size of how much human readers improve with AI vs. without AI assistance:

Not applicable. This device is a bone void filler, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and not mentioned.

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

Not applicable. This device is a medical implant, not an algorithm or software.

7. The Type of Ground Truth Used:

Not applicable. No "ground truth" is used in the context of a performance study for this device as described in the summary. The substantial equivalence is based on comparing the device's material composition, physical properties (e.g., pore diameter, porosity), and intended use to predicate devices.

8. The Sample Size for the Training Set:

Not applicable. No "training set" is mentioned, as this is not an algorithm or AI-based device.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set mentioned.

Summary of the Document's Approach:

The 510(k) summary for Synthacer® and Syntricer® relies entirely on substantial equivalence to predicate devices (Pore-Si Bone Graft Substitute/Apapore Bone Graft Substitute and Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler). The "study" proving the device meets acceptance criteria, in this context, is the comparison of its technological characteristics and intended use to these legally marketed devices.

The key arguments for substantial equivalence are:

Similar Intended Use: Both Synthacer®, Syntricer®, and their predicates are intended as bone void fillers for voids or gaps not intrinsic to bony stability, and for treating surgically created or traumatic osseous defects.
Similar Technological Characteristics:
- Synthacer®: Porous calcium phosphate (at least 95% pure hydroxyapatite), average pore diameter 600um, 60-80% porosity, radiopaque, provided sterile in various forms.
- Syntricer®: Porous calcium phosphate (at least 95% pure tricalcium phosphate), average pore diameter 600um, 60-80% porosity, provided sterile in various forms.
  These characteristics are presumably similar to those of the predicate devices, though the specific characteristics of the predicates are not detailed in this summary.
Mechanism of Action: Both devices are described as osteoconductive, promoting new bone growth, and designed to resorb over time as bone grows into the space. This is consistent with the general understanding of bone void fillers.

In essence, the "proof" is that the new devices are fundamentally similar to devices already deemed safe and effective by the FDA. This type of submission does not typically involve a de novo clinical trial or performance study with defined acceptance criteria and statistical analysis as might be done for novel devices or diagnostic algorithms.

Summary

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K04 1177 V3

JUN 2 3 2005

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Synthacer® and Syntricer® Calcium Salt Bone Void Filler(s)

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of Synthacer® and Syntricer® is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.

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

MedArtis AG	Phone:	+49 89 642 30 89
Medizinprodukte and Forschung	Facsimile:	+49 89 642 34 87
Gabriel-Max-Str. 3	Date Prepared:	June 20, 2005
D-81545 Muenchen
Germany
Contact Person:	Phone:	+41 71 694 5585
	Facsimile:	+41 71 694 5589
Knut Hülse, Ph.D.	Email:	N/A

Name of Device and Name/Address of Sponsor

1. Synthacer® Calcium Salt Bone Void Filler
1. Syntricer® Calcium Salt Bone Void Filler

MedArtis AG Medizinprodukte and Forschung Gabriel-Max-Str. 3 D-81545 Muenchen Germany

Classification Name

The submitted resorbable calcium salt bone void filler is a Class II product with the associated regulation and product code.

MedArtis Product	Product Name	Regulation	Code
Synthacer® Calcium Salt Bone Void Filler	Synthacer®	888.3045	MQU
Syntricer® Calcium Salt Bone Void Filler	Syntricer®	888.3045	MQU

Predicate Devices

Trade Name
Pore-Si Bone GraftSubstitute/Apapore Bone GraftSubstitute: Apatech LTD	Vitoss™ Scaffold SyntheticCancellous Bone Void Filler:Orthovita
Common Name
Bone Void Filler	Bone Void Filler

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Device Description

Intended Use

Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, Synthacer® Calcium Salt Bone Void Filler and Syntricer® Calcium Salt Bone Void Filler and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the device, medArtis AG believes that no significant differences exist between Synthacer® Calcium Salt Bone Void Filler and Syntricer® Calcium Salt Bone Void Filler and the predicate devices.

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MedArtis AG believes the minor differences of the medArtis AG calcium salt bone void filler(s) and its predicate devices should not raise any concerns regarding the overall safety or effectiveness.

This information was prepared for the sole purpose of compliance with the Safe Advisory: Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2005

Knut Hülse, Ph.D. Regulatory Affairs MedArtis AG Gabriel-Max-Strasse 3 D-81545 München, Germany

Re: K041177

Trade Name: Synthacer® Calcium Salt Bone Void Filler and Syntricer® Calcium Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: June 1, 2005 Received: June 3, 2005

Dear Dr. Hülse:

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 – Knut Hülse, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and wy a the FDA finding of substantial equivalence of your device to a legally premated 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 if you atence specific arrangliance at (240) 276-0120. Also, please note the regulation entitled, eonidor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.

Sincerely yours,

Muriam C. Provost

Miriam C. Provost, Ph.D. Acting 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

510(k) Number (if known): K041177

Synthacer® Calcium Salt Bone Void Filler & Syntricer® Device Name: Calcium Bone Void Filler

Indications for Use:

Synthacer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability is all a really area miller volus of gape in bone ted for use in the treatment of surgically created strature. Oynthator osseous defects created from traumatic injury.

Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void Synthcer - Oalchum Oult Bone that are not intrinsic to the stability of the bony miler for volus of gaps in the treatment of surgically created Structure. Oynthour its easy defects created from traumatic injury.

Prescription Use: X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter (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)

Page 1 of 1

Muriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.