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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 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.

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

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

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic device or a pass/fail threshold for a therapeutic device.

Instead, the document is a 510(k) Summary Statement for two medical devices, B-GENIN and R-GENIN, which are resorbable calcium salt bone void fillers. The "study" mentioned is not a clinical trial with acceptance criteria for device performance, but rather a set of tests to establish substantial equivalence to predicate devices and confirm certain material properties and safety aspects.

Here's a breakdown of the available information based on your requested categories, acknowledging that much of what you asked for is not explicitly present in this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Viral Inactivation: The document mentions "a select panel of viruses." No specific sample size (number of viruses tested, repeats of tests) is provided, nor is the provenance of the viral strains. This is a lab-based, in vitro study.
• Osteoconductive Potential: Uses an "athymic nudemouse model." No specific sample size (number of mice or DBM samples per batch) is provided. This is an in vivo animal model study. Data provenance is implied as being from the manufacturer's internal testing as part of "batch testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The tests described are laboratory and animal studies, not human clinical studies requiring expert review of outcomes for "ground truth" establishment in the context of diagnostic or classification tasks. The histopathological evaluation in the nudemouse model would be performed by trained personnel (e.g., veterinary pathologists), but their number and qualifications are not specified.

4. Adjudication Method for the Test Set

Not applicable. The described "tests" are primarily laboratory and animal studies evaluating material properties and biological activity, not clinical studies with outcomes requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes a 510(k) submission, which focuses on substantial equivalence to existing predicate devices. It does not include a comparative effectiveness study, especially not one involving human readers and AI for an orthopedic bone void filler.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not a software/AI device. The "device" is a physical bone void filler.

7. Type of Ground Truth Used

• Viral Inactivation: Laboratory assay results demonstrating viral reduction.
• Osteoconductive Potential: Histopathological evidence of new bone formation in a nudemouse model. This is an animal model endpoint/biological readout. The document explicitly states this assay "should not be interpreted to predict clinical performance in human subject."
• Substantial Equivalence: Comparison of material properties, intended use, and general characteristics to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The concept of a "training set" for an algorithm does not apply here.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for an algorithm. The "truth" for this device's safety and effectiveness relies on material characterization, viral inactivation studies, and animal model results, along with the established safety profiles of the predicate devices.

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