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BioPlus is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The granules or blocks may be pressed into the void or into the surgical site by hand. The BioPlus granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.

BioPlus is a sterile osteoconductive bone void filler. It consists of a formulation of calcium-based compounds. This synthetic bone graft comes in the shape of granules or blocks. BioPlus is supplied sterile for single patient use only. BioPlus is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications-for-use. The implant is bioresorbable and radio-opaque.

The provided text is a 510(k) summary for a medical device (BioPlus Bone Void Filler) and related FDA correspondence. It does not include information about specific acceptance criteria or a study that proves the device meets those criteria in the way described in the request (e.g., performance metrics like sensitivity, specificity, or human-AI comparison).

The submission relies on demonstrating substantial equivalence to a predicate device (Bi-Ostetic™ - K023703) rather than proving performance against specific quantitative acceptance criteria through a standalone study with performance metrics.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided input. The document focuses on regulatory equivalence rather than a clinical performance study with specific quantifiable results.

Here's a breakdown of why the requested information cannot be extracted:

• Acceptance Criteria & Reported Performance: The document states that "The safety and effectiveness of BioPlus are adequately supported by the substantial equivalence information, materials data, and test results provided in the full document." However, it does not detail specific performance metrics (e.g., regarding bone ingrowth rate, void filling efficacy, or resorption time) or define quantitative acceptance criteria for those metrics. The "test results" mentioned are likely biocompatibility tests, material characterization, and potentially animal studies (though not detailed here), rather than a clinical trial with statistical performance endpoints.
• Study Design Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a clinical performance study. Since the submission relies on substantial equivalence and mentions "materials data, and test results" without detailing a clinical study with human or animal subjects that establishes specific performance against acceptance criteria, these details are absent.
• Training Set Information: This is relevant for AI/ML devices. BioPlus is a physical bone void filler, not an AI/ML diagnostic or therapeutic device. Thus, there is no training set in the context of machine learning.

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