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OsteoFlo® HydroPutty™ is indicated for bony voids or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device provides a bone void filler that is resorbed with host bone during the healing process.

The OsteoFlo® HydroPutty™ is a resorbable bone void filler comprised of porous carbonated apatite granules and bioglass, in a synthetic polymer binder. The OsteoFlo® HydroPutty™ is intended to be easily packed into osseous defects. The single-use device is supplied sterile via gamma radiation and dry. The device requires mixing with aqueous sterile saline solution in a 1:1 ratio prior to use. The OsteoFlo® HydroPutty™ is supplied as either a pre-filled syringe or vial, in 1, 2.5, 5 and 10mL configurations.

The provided document is a 510(k) summary for the OsteoFlo® HydroPutty™ bone void filler device. It does not include acceptance criteria or a study that specifically proves the device meets such criteria in the traditional sense of a performance study with metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/software device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. The "acceptance criteria" here are effectively the successful completion of these non-clinical tests, showing that the device meets established standards for biocompatibility, sterility, packaging, shelf-life, and material characteristics, and performs comparably to the predicate in an in vivo animal study.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Equivalence)

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

The document describes an "in vivo evaluation in a critical-size rabbit femoral defect model."

• Sample Size: The exact number of rabbits used in this animal model is not specified in the provided text.
• Data Provenance: The study was an animal model (in vivo rabbit study), which is typically prospective.

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

This type of information (experts establishing ground truth for a test set) is typically relevant for studies evaluating the diagnostic accuracy or interpretive performance of a device (e.g., AI algorithms for image analysis). For a bone void filler device evaluated in an in vivo animal model, the "ground truth" for bone formation and absorption would likely be established through histological analysis, micro-CT imaging, and other quantitative measures performed by veterinary pathologists or researchers. The document does not provide details on the number or qualifications of such experts, as it is a summary focused on substantial equivalence.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies where human readers are interpreting data and consensus is needed for ground truth. Since this study involved an in vivo animal model and non-clinical tests, such a method would generally not be applicable or described in this context.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a bone void filler device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This concept is applicable to AI/software devices, not physical medical devices like a bone void filler.

7. The Type of Ground Truth Used

For the in vivo evaluation, the ground truth would be based on direct biological observation and quantitative assessment of bone formation and device absorption in the rabbit model (e.g., histological analysis, radiographic imaging, micro-CT evaluations). The document states "Effectiveness, in terms of device absorption and bone formation, has been shown in the animal study."

8. The Sample Size for the Training Set

This concept is specific to machine learning/AI models. As this document describes a physical medical device (bone void filler) and not an AI algorithm, there is no "training set" as understood in AI development.

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

Not applicable, as there is no AI training set.

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