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B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion.

B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM). The device is an implant where new bone can grow.

R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, hydroxyapatite, tri-calcium phosphate, and DBM. The device is an implant where new bone can grow.

This regulatory submission (K113791) for B-GENIN and R-GENIN indicates that the device's safety and effectiveness are supported by its substantial equivalence to a previously cleared device (K091912). Therefore, a detailed study proving the device meets specific acceptance criteria in the manner typically seen for novel devices is not present in the provided text.

Instead, the submission relies on demonstrating that the new devices are essentially the same as a device already on the market. The "Acceptance Criteria" in this context are primarily related to the manufacturing and testing of the DBM component, ensuring its osteoconductive potential and viral inactivation.

Here's an breakdown based on the information provided, emphasizing that the "study" is more about process validation and equivalence than a clinical performance trial:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study and its details:

The primary "study" described here is more of a process validation and comparability assessment rather than an independent clinical trial.

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

• Viral Inactivation: The sample size is not explicitly stated. The "test set" would be the panel of viruses used ("human immunodeficiency virus (HIV-1), hepatitis A virus, hepatitis C virus (bovine viral diarrhea as model), porcine parvovirus, and pseudorabies virus"). Data provenance is not specified, but this would typically be laboratory-generated data from studies conducted by the manufacturer or a contract lab.
• Osteoconductive Potential: The sample size for each batch of DBM is not specified, but involves an athymic nude-mouse model. The reference to "Edwards, J. T., Diegmann M. N., Scarborough, N. L.; Osteoinduction of human deminerslized bone: characterization in a rat model, Clin. Orthopaedies, Vol. 357, pp. 219-28 (1998)" suggests the methodology is based on established scientific literature, likely from a lab setting. The data would be proprietary to the manufacturer or a contracted lab. It's a prospective test for each batch.
• Substantial Equivalence: This is a comparison to a retrospective set of information (K091912) rather than a test set with a specific sample size.

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

• Viral Inactivation & Osteoconductive Potential: The document does not specify the number or qualifications of experts involved in establishing ground truth for these lab tests. These are typically assessed by qualified laboratory personnel following established protocols.
• Substantial Equivalence: The ground truth is the prior FDA clearance of K091912. The experts involved in that initial clearance (FDA reviewers) are not detailed here, and for this submission, the ground truth is the established equivalence to that device.

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

• None explicitly stated. For lab tests like viral inactivation and osteoinduction, internal quality control and peer review within the lab would be assumed, but no formal adjudication method like a "2+1" or "3+1" approach is mentioned.

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 submission is for a bone void filler product, not an AI/software device that would involve human readers or image interpretation. Therefore, an MRMC study and AI-related effect sizes are not relevant here.

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

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

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

• Viral Inactivation: Laboratory assay results demonstrating a reduction in viral load using established scientific methods.
• Osteoconductive Potential: Histopathological evidence of new bone formation in an animal model, observed and scored by qualified laboratory personnel, based on a reference standard (Edwards, et al. 1998).
• Substantial Equivalence: Prior FDA clearance of the predicate device (K091912) based on its documented safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This submission does not describe an AI/ML device that requires a training set. The "training" for this device would be its manufacturing process and quality controls.

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

• Not applicable. As above, no training set for an algorithm is discussed. The "ground truth" for the overall device's safety and effectiveness relies on its similarity to the predicate device and validation of its manufacturing processes for viral inactivation and osteoinductive potential.

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