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Integra MOZAIK™ Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremittes, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK™ Osteoconductive Scaffold - Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIKTM Osteoconductive Scaffold - Strip is resorbed and replaced with bone during the healing process.

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is a porous resorbable bone void filler made from highly purified bovine Type I collagen and calcium salt (8-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088).

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip bone grafting construct is designed to facilitate the repair of bony defects. The matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The three dimensional pore structure quickly imbibes fluids, making it easy to combine bone marrow aspirate.

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip guides bone regeneration across a critical defect site into which the products are implanted. New bone forms in apposition to the matrix surface when the grafts are placed in direct contact with viable host bone. Ultimately, the matrices are resorbed and remodeled into bone.

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is provided sterile, nonpyrogenic, for single use in double peel packages.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Integra MOZAIK™ Osteoconductive Scaffold - Strip (5cc):

It is important to note that the provided documents (FDA 510(k) summary) describe a substantial equivalence determination for a new size (5cc) of an existing medical device. This means the primary "study" demonstrated that the 5cc device is equivalent to a previously cleared 15cc device, rather than proving the 5cc device's de novo clinical efficacy through a traditional clinical trial with specific acceptance criteria on performance metrics like sensitivity, specificity, etc. Therefore, many of the requested fields (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable or explicitly stated in the context of this 510(k) submission.

Acceptance Criteria and Device Performance

Study Details (as inferable from a 510(k) submission for substantial equivalence):

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable in the context of a clinical test set for performance metrics like sensitivity/specificity. The "test set" here refers to the actual 5cc device being compared against the predicate.
   • Data Provenance: The document does not specify a separate "test set" derived from studies involving patients. Instead, the basis of data provenance for equivalence is likely derived from laboratory testing (mechanical, chemical, physical properties) of the 5cc device and a reliance on the existing pre-clinical and clinical data of the predicate 15cc and 10cc devices. The phrase "biocompatibility and in vivo performance testing will be applied to the 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip" suggests the previous study's data is leveraged, rather than new, separate human/animal studies for the 5cc, specifically for biocompatibility and in vivo performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth, in this context, would relate to clinical outcomes or expert diagnoses, which are not directly assessed for the 5cc device in this submission, as it relies on equivalence to a predicate. The "ground truth" for the equivalence claim is the established safety and effectiveness of the existing predicate device.

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

   • Not applicable. This type of adjudication method is used in studies where multiple human readers review cases to establish a consensus ground truth for evaluating AI performance. This submission does not involve such a process.

4. 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:

   • No, a MRMC comparative effectiveness study was not done. This device is a bone void filler, not an AI diagnostic tool that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a physical medical implant, not an algorithm.

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

   • The "ground truth" here is the established safety and effectiveness profile of the legally marketed predicate device (15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124)). This profile would have been based on a combination of:
     • Laboratory testing (physical, chemical, mechanical properties)
     • Biocompatibility testing (in vitro and/or in vivo animal studies)
     • In vivo performance testing (animal studies demonstrating bone regeneration and resorption)
     • Potentially clinical outcomes data from the predicate's use.
   • For the 5cc device, the ground truth is its verified similarity in materials, design, and performance to this well-established predicate.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI model requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, this device is not an AI model.

Summary of the "Study" Proving Equivalence:

The "study" in this context is a bench and literature-based comparative analysis as part of a 510(k) submission. Integra LifeSciences Corporation demonstrated that the 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip meets the acceptance criteria for substantial equivalence to its predicate (the 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip, K063124) by:

• Asserting identical materials, design, performance, and intended use.
• Conducting performance tests on the 5cc device to ensure it meets specifications, with all results being acceptable.
• Leveraging the biocompatibility and in vivo performance testing data from the predicate device based on FDA guidance for Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (June 2, 2003).

The conclusion is that the change in size (from 15cc to 5cc) does not alter the fundamental scientific technology or raise new issues of safety or effectiveness, thus proving substantial equivalence rather than independent clinical efficacy.

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