Stryker® TCP Putty is indicated as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. It should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Stryker® TCP Putty 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 or gap, Stryker® TCP Putty is resorbed and replaced with bone during the healing process.

Device Description

Stryker® TCP Putty is an absorbable bone void filler composed of porous tri-calcium phosphate granules and carboxymethylcellulose, sodium (CMC) putty additive. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone and other connective tissues. The putty consistency allows the shape of the implant to conform to the defect, maximizing direct contact with viable host bone.

AI/ML Overview

This 510(k) summary (K041421) pertains to the Stryker® TCP Putty, a bone void filler. The provided document focuses on establishing substantial equivalence to predicate devices rather than describing a study with defined acceptance criteria and detailed device performance metrics in the way one would typically see for an AI/ML device.

Therefore, many of the requested elements for describing such a study (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI models) are not applicable to this type of medical device submission.

The "acceptance criteria" for a traditional device like this generally revolve around demonstrating that the new device is as safe and effective as existing legally marketed predicate devices. This is typically achieved through comparisons of material properties, mechanical testing, biocompatibility, and sometimes animal or clinical data, to show that the new device performs similarly and meets its intended use.

Here's an attempt to extract relevant information given the context of a 510(k) summary for a bone void filler:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a bone void filler based on substantial equivalence, explicit "acceptance criteria" and "reported device performance" in the quantifiable terms of an AI/ML device study are not presented in the document itself. The "acceptance criteria" implicitly relate to demonstrating that the device's characteristics (material, physical, and performance) are comparable to the identified predicate devices, ensuring it is as safe and effective for its stated intended use.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as described in application)
Material Composition: Composed of materials similar to predicates (resorbable calcium salt, carrier).	Composed of porous tri-calcium phosphate granules and carboxymethylcellulose, sodium (CMC) putty additive.
Intended Use: Similar indications for use as predicates.	Indicated as a bone void filler for voids/gaps not intrinsic to stability, occurring from surgical defects or traumatic injury. Not for large defects that wouldn't heal spontaneously. Intended for skeletal system (extremities, spine, pelvis).
Mechanism of Action: Osteoconductive, resorbable, and replaced by bone during healing, similar to predicates.	Osteoconductive implant with multidimensional porosity; acts as a scaffold for in-growth of new bone/connective tissue. Resorbed and replaced with bone during healing.
Physical Characteristics: Putty consistency allowing conformity to defect, similar to predicates.	Putty consistency allows conformity to defect, maximizing direct contact with viable host bone.
Performance (Biocompatibility, Mechanical, Degradation): Demonstrated through laboratory and animal testing to be comparable to predicate devices.	Laboratory testing and animal testing were provided to characterize the subject device and to allow comparison of its characteristics to predicate devices. (Specific results not detailed in summary).

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

This information is not provided in the 510(k) summary. The testing mentioned refers to "Laboratory testing and animal testing." Details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests are typically found in the full 510(k) submission, not in the public summary.

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

This type of information is not applicable to this 510(k) submission, as it does not involve an AI/ML model where expert ground truth is established for a test set.

4. Adjudication Method for the Test Set

This information is not applicable to this 510(k) submission, as it does not involve expert review or adjudication of a test set in the context of an AI/ML device.

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

This information is not applicable to this 510(k) submission. MRMC studies are relevant for imaging devices or AI tools that assist human readers/clinicians, which is not the nature of a bone void filler.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable to this 510(k) submission, as it relates to an AI/ML algorithm and not a physical bone void filler device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a bone void filler, "ground truth" would typically relate to biological outcomes observed in in vivo (animal) studies or clinical trials, such as evidence of bone ingrowth, material resorption, absence of adverse reactions, and defect healing. The summary only broadly states "animal testing" was performed, but does not detail the specific outcome measures or how "ground truth" was ascertained in those studies.

8. The Sample Size for the Training Set

This information is not applicable to this 510(k) submission, as it relates to AI/ML model training, not a physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable to this 510(k) submission, as it relates to AI/ML model training, not a physical device.

Summary of the Study that Proves the Device Meets the (Implicit) Acceptance Criteria:

The 510(k) summary indicates that Laboratory testing and animal testing were performed to characterize the Stryker® TCP Putty and to compare its characteristics to predicate devices. While specific details of these studies (e.g., number of animals, specific lab tests, endpoints, results) are not included in this public summary, the FDA's clearance (AUG 26 2004) implies that these studies adequately demonstrated that the device is substantially equivalent to the identified predicate devices in terms of its intended use, materials, device performance, and physical characteristics. This means the device was deemed to be as safe and effective as the predicates. The predicate devices listed are:

K994337: Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler (Orthovita, Inc.)
K021963: BIOSORB® Resorbable Void Filler (Sciences et Bio Materiaux)
K010555: JAX™ Bone Void Filler (Smith & Nephew, Inc.)
K020895: Allomatrix Putty (Wright Medical Technology, Inc.)

Summary

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K041421

AUG 2 6 2004

510(k) Summary :

Proprietary Name:	Stryker® TCP Putty
Common Name:	Bone Void Filler
Classification Name:	Resorbable calcium salt bone void fillerdevice
Reference:	21 CFR 888.3045
Device Product Code:	MQV - Filler, Calcium,Preformed Pellet
Submitted By:	Stryker Biotech35 South StreetHopkinton, MA 01748
Contact Information:	Sharon McDermottRegulatory SpecialistPhone: (508) 416-5200Fax: (508) 544-6150
Date Summary Prepared:	27 May 2004

Device Description:

Intended Use:

Summary of substantial equivalence:

The intended use, materials, device performance and physical characteristics of Stryker® TCP Putty are substantially equivalent to those found in one or more of the following predicate devices.

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K994337: Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler_(Orthovita, Inc.)

K021963: BIOSORB® Resorbable Void Filler (Sciences et Bio Materiaux)

K010555: JAX™ Bone Void Filler (Smith & Nephew, Inc.)

K020895: Allomatrix Putty (Wright Medical Technology, Inc.)

Testing Summary

Laboratory testing and animal testing were provided to characterize the subject device and to allow comparison of its characteristics to predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

Ms. Sharon McDermott Regulatory Affairs Specialist Stryker Biotech 35 South Street Hopkinton, MA 01748

Re: K041421

Stryker® TCP Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: May 27, 2004 Received: May 28, 2004

Dear Ms. McDermott:

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 - Ms. Sharon McDermott

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 promainer neted 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), r you 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 may overn 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.

Mark N. Millhusan

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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Indications for Use

510(k) Number (if known): K041421

Stryker® TCP Putty Device Name:

Indications For Use:

TCP Putty is indicated as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or stations defects resulting from traumatic injury. It should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

TCP Putty is intended to be gently packed into bony voids or gaps of the skeletal system 1 cr 1 any is mittingul to 5 gelpelvis). Following placement in the bony void or gap, the tri-calcium phosphate scaffold is resorbed and replaced with bone during the healing process.

Prescription Use: X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices Page 1 of 1

510(k) Number	K041421
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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.