GRAFTYS® Quickset is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® Quickset is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

GRAFTYS®QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. Invivo, this apatite which hardens in approximately 2min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®QUICKSET is a sterile single-use product.

AI/ML Overview

The provided text describes a 510(k) summary for the GRAFTYS® QUICKSET Resorbable Bone Void Filler. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics in the way one might expect for a diagnostic or therapeutic device that directly measures or treats a condition.

Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with statistical endpoints is not directly applicable or present in this document. Instead, the "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data from in vitro testing.

Here's an attempt to extract the requested information based on the provided text, with clarifications where direct answers are not available:

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

Since this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are not explicit numerical targets for clinical performance but rather a demonstration that the new device is as safe and effective as the predicate based on in vitro testing.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate K082498)	Reported Device Performance (GRAFTYS® QUICKSET)
Intended Use Equivalence: Same intended use as predicate.	"GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure... and is replaced with bone during the healing process." (Matches predicate's likely intended use as "Resorbable calcium salt bone void filler device")
Principle of Operation Equivalence: Same principle of operation as predicate.	"GRAFTYS® QUICKSET and the predicate GRAFTYS®HBS devices have the same... principle of operation." (Self-hardening macroporous synthetic calcium phosphate bone substitute, resorbs and replaced by bone.)
Technological Characteristics Equivalence: Similar technological characteristics, minor differences do not raise new safety/effectiveness issues.	"very similar technological characteristics. The minor technological differences do not raise any new issues of safety or effectiveness." (Made from calcium phosphate salts, HPMC, and phosphate-based aqueous solution; athermally forms injectable calcium-deficient apatite; hardens in ~2 min.)
Biocompatibility: Safe for use in the body.	Not explicitly detailed, but implicit in "in vitro testing, performed according to the Guidance Class II Special Controls Guidance Document... support the substantial equivalence." This guidance would typically cover biocompatibility.
Mechanical Properties (e.g., hardening time, injectability, strength): Performance comparable to predicate.	"Invivo, this apatite which hardens in approximately 2min". "injectable self-hardening". "injection is administered manually or using a delivery gun." Specific comparative data to predicate not explicitly listed but implied to be sufficient for equivalence.
Resorption and Bone Replacement: Functions similarly to predicate.	"resorbs and is replaced with bone during the healing process." (Implicitly comparable to predicate)

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

Sample size: Not applicable in the context of in vitro testing described. The primary "test set" for substantial equivalence was the predicate device itself, against which performance was compared. Specific sample sizes for in vitro experiments (e.g., number of specimens tested for mechanical properties) are not provided.
Data provenance: "In vitro testing" was performed. The company is based in France ("Eiffel Park – Bât D 415, rue Claude Nicolas Ledoux- 13 854 AIX EN PROVENCE Cedex3 FRANCE"), so presumably, the in vitro testing was conducted there or by a contract lab. It is inherently retrospective testing of device properties, not a prospective clinical trial.

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. This device is not a diagnostic tool requiring expert interpretation or ground truth establishment in the clinical sense. The "ground truth" for in vitro performance is based on established engineering and materials science standards.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 a bone void filler, 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 a bone void filler, not an algorithm.

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

The "ground truth" for demonstrating the safety and effectiveness of the GRAFTYS® QUICKSET in this 510(k) submission relies on:

Predicate device characteristics: The established safety and effectiveness of the legally marketed GRAFTYS® HBS.
Compliance with standards/guidance: "in vitro testing, performed according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device; Guidance for Industry and FDA June 2, 2003." This document outlines the expected performance and safety considerations for this class of devices.

8. The sample size for the training set

Not applicable. There is no training set in the machine learning sense for this device. The development process would involve materials science research and optimization, but not a "training set" like for AI.

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

Not applicable. See point 8.

Summary

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K093343

Graftys

GRAFTYS® Quickset Resorbable Bone Void Filler 510(k) Summary

APR 2 2 2010

Prepared: October, 14, 2009

1. Submitter Information

Name :	GRAFTYS
Address :	Eiffel Park – Bât D415, rue Claude Nicolas Ledoux-13 854 AIX EN PROVENCE Cedex3FRANCE
Telephone:	+ 33 (0) 4 42 60 30 00
Facsimile:	+ 33 (0) 4 42 60 30 11
Contact:	Anthony LE NAOUR - Regulatory Manager

2. Name of Device

Trade Name:	GRAFTYS®QUICKSET
Common Name:	Resorbable calcium salt bone void filler device
Classification name:	Resorbable calcium salt bone void filler device (CFR 888.3045; Product Code : MQV)

3. Legally Marketed Predicate Device

Predicates GRAFTYS®HBS - Resorbable calcium salt bone void filler device [K082498]

4. Device Description

GRAFTYS - S.A. au capital de 537.037 Euros - Siret 484 024 989 - APE 2120Z Eiffel Park - Bât D - 415, rue Claude Nicolas Ledoux - F-13 854 Aix en Provence Cedex 3, France Tel : +33 (0)4 42 60 30 00 - Fax : + 33 (0)4 42 60 30 11 - contact@graftys.fr www.graftys.com

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Image /page/1/Picture/1 description: The image shows a large, bold letter 'G' on the left side. To the right of the 'G', there is a smaller, less distinct symbol that appears to be the number '5'. The number '5' is partially obscured and has a textured or grainy appearance, contrasting with the solid black 'G'.

Graftys

5. Intended Use

GRAFTYS®QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

6. Technological characteristics

GRAFTYS®QUICKSET and the predicate GRAFTYS®HBS devices have the same intended use, the same principle of operation and very similar technological characteristics. The minor technological differences do not raise any new issues of safety or effectiveness.

7. Non clinical performance data

In vitro testing, performed according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device; Guidance for Industry and FDA June 2, 2003, support the substantial equivalence between GRAFTYS®QUICKSET and the predicate device GRAFTYS®HBS.

8. Conclusion

GRAFTYS®QUICKSET is claimed to be substantially equivalent in term of safety and effectiveness to the predicate devices GRAFTYS®HBS as a resorbable calcium salt bone void filler device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it, topped by wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

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

GRAFTYS APR 2 2 2010 % Mr. Anthony Le Naour Regulatory Affairs Manager Eiffel Park – Bât D 415, rue Claude Nicolas Ledoux 13854 AIX EN PROVENCE Cedex3 France

Re: K093343

Trade/Device Name: GRAFTYS® Quickset Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 30, 2010 Received: March 30, 2010

Dear Mr. Le Naour:

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.

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

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Page 2 - Mr. Anthony Le Naour

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 (Sections 531-542 of 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 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, 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/ReportaProblem/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 address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Barbara Boettner

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Graftys GRAFTYS®QUICKSET- Resorbable Bone Void Filler

Statement of Indications for Use

510(k) Number (if known): K093343

Device Name:

GRAFTYS® Quickset

Indications For use:

GRAFTYS® Quickset is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® Quickset is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

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

Over-The-Counter Use (Part 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)

Division Sign-Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093343

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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.