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STERLING® Cancellous Chips and STERLING® Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

STERLING® Cancellous Chips and STERLING® Cancellous Cubes are manufactured from bovine bone processed with the BioCleanse" Tissue Sterilization Process. STERLING® Cancellous Chips and STERLING® Cancellous Cubes are provided in 1-10mm sizes, with 15-90cc per package.

This document, a 510(k) summary for the STERLING® Cancellous Chips and STERLING® Cancellous Cubes, does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

This submission is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (PolyGrafi™ BGS). The information provided focuses on the device's description, intended use, and a summary of technological characteristics, rather than a detailed performance study with acceptance criteria.

However, based on the provided text, I can extract what is mentioned:

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

This document does not present a formal table of acceptance criteria nor specific quantitative performance metrics. Instead, it makes two qualitative claims about performance:

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

• Animal Model for Remodeling: The document mentions an "animal model" but provides no information on the sample size used, the specific type of animals, the country of origin, or whether the study was retrospective or prospective.
• Viral Inactivation Study: The document mentions a "viral inactivation study" but provides no information on the sample size (e.g., number of replicates, types of viruses), the country of origin for the data, or its retrospective/prospective nature.

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):

This information is not provided in the document for either the animal model or the viral inactivation study. The concept of "ground truth" as typically defined in AI/diagnostic studies (e.g., expert consensus on images or pathology confirmation) is not applicable here, as these are material science and biological efficacy studies.

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

This information is not applicable to the types of studies mentioned (animal model for remodeling, viral inactivation study), which typically involve laboratory measurements and histological/virological analyses rather than interpretation by multiple human readers.

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 is not applicable. The device is a bone void filler, not an AI diagnostic tool. Therefore, an MRMC study is irrelevant.

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

This is not applicable. The device is a physical medical device, not an algorithm.

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

• Animal Model for Remodeling: The "ground truth" would likely be based on histological analysis and potentially imaging (e.g., X-ray, micro-CT) of bone formation and integration in the animal model, compared to allograft.
• Viral Inactivation Study: The "ground truth" would be based on quantitative virological assays to measure the reduction in viral titer after exposure to the BioCleanse® process.

8. The sample size for the training set:

This is not applicable. The document describes a physical medical device and its processing, not an algorithm that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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