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The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels, combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are 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 Mozaik Moldable Morsels and Integra OS Moldable Morsels are resorbed and replaced with bone during the healing process.

The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are resorbable bone void fillers made from a porous highly purified collagen matrix that has high purity beta tricalcium phosphate (B-TCP) granules and cubes dispersed throughout. The implant is provided sterile, non-pyrogenic, for single use in double peel packages.

The Integra Mozaik Moldable Morsels and Integra Moldable Morsels bone grafting construct are designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels quickly imbibe fluids, making it easy to combine with bone marrow aspirate.

Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels guide the regeneration of bone across the defect site into which the Moldable Morsels are implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.

The provided document is a 510(k) Premarket Notification for a medical device (Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels). This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device's efficacy through extensive clinical trials with an AI component.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details.

The document primarily focuses on:

• Device Description: What the device is made of and how it works.
• Intended Use: The clinical situations for which the device is designed.
• Substantial Equivalence: A claim that the device is similar in function and intended use to an already marketed predicate device (Integra MOZAIK Osteoconductive Scaffold - Putty (K062353)).
• Conclusion: States that "Valid scientific evidence through physical property testing provide reasonable assurance that Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are safe and effective under the proposed conditions of use..." This refers to non-clinical, benchtop testing, not clinical studies in the context of diagnosing or detecting conditions with AI.

To answer your request based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for a diagnostic or AI device. The general acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness.
• Reported Device Performance: The document states that "Valid scientific evidence through physical property testing provide reasonable assurance that Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are safe and effective under the proposed conditions of use." Specific performance values (e.g., sensitivity, specificity, accuracy) are not provided as this is not an AI diagnostic device.

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

• Not Applicable. This document describes a bone void filler, not an AI or diagnostic device that would typically use clinical test sets of patient data. The "testing" mentioned refers to physical property testing of the material, not clinical data analysis.

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. No ground truth establishment by experts for a test set is described, as this is not an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a medical implant, 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 medical implant, not an algorithm.

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

• Not Applicable. No ground truth in the context of diagnostic performance is described. The "ground truth" for this device would relate to its material properties (e.g., porosity, resorption rate, mechanical strength), which are assessed through physical property testing.

8. The sample size for the training set

• Not Applicable. This device is not an AI model that requires a training set.

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

• Not Applicable. This device is not an AI model that requires a training set or ground truth establishment in that context.

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