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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.

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.

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.

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.)

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