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The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Device Description

OSS Bone Graft System and OSS RapidSet Bone Graft System are packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively to produce a homogenous paste that can be applied to bone gaps or defects. The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate. The liquid component is a solution comprised of anhydrous citric acid (C6H8O7) and distilled water (H2O). When mixed, the powder and liquid combine to form a homogenous paste.

AI/ML Overview

The provided text describes the 510(k) summary for the Biomet OSS Bone Graft System and OSS RapidSet Bone Graft System. Based on the document, here's an analysis of the acceptance criteria and study information:

Key Finding: The submission states "Clinical Testing: None provided," meaning no specific human clinical study was conducted to prove the device met acceptance criteria, as it was cleared through the 510(k) substantial equivalence pathway. The clearance relies primarily on non-clinical testing and similarity to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Material Composition	Not explicitly stated as "acceptance criteria," but implied that composition should be safe and effective for its intended use.	"The materials, design and processing OSS Bone Graft System and OSS RapidSet Bone Graft System are similar or identical to the predicate products."	Substantial equivalence to predicate devices (K990290, K023718, K003494, K011048, K011897, K990131) forms the basis for acceptance. The device is a "mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate" for the powder, and "anhydrous citric acid (C₆H₈O₇) and distilled water (H₂O)" for the liquid.
Physical/Chemical Properties
Elemental Analysis	Not explicitly stated as acceptance criteria.	Elemental analysis was performed.	This testing likely confirms the material composition and purity.
Set Time	Not explicitly stated as acceptance criteria, but implies a functional set time suitable for surgical application.	Determination of set time was performed.	Essential for surgeons to have a predictable working time.
X-ray Diffraction Analysis	Not explicitly stated as acceptance criteria.	X-ray diffraction analysis was performed.	Used to characterize the crystalline structure of the ceramic component.
Surface pH	Not explicitly stated as acceptance criteria, but crucial for biocompatibility.	Determination of surface pH was performed.	Surface pH needs to be within a biocompatible range to avoid adverse tissue reactions.
Exothermic Temperature	Not explicitly stated as acceptance criteria, but critical for patient safety during application.	Exothermic temperature was determined.	Excessive heat generation during setting could cause tissue damage.
Biocompatibility	Not explicitly stated as "acceptance criteria," but implied based on the nature of an implantable device.	Not explicitly detailed, but usually covered by material composition similarity to known biocompatible predicate devices or standard biocompatibility testing.	The 510(k) process often relies on existing data for predicate devices.
Sterility	Not explicitly stated as "acceptance criteria."	Not explicitly detailed.	Implied requirement for a device intended for surgical implantation, usually demonstrated through validation of sterilization processes.
Intended Use	Device must be suitable for "filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis)" where defects are "surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone." The device is intended "for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure."	The device is cleared for this intended use based on substantial equivalence.
Clinical Performance	Not applicable for this submission.	None provided.	The submission explicitly states no clinical testing was performed.

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

Sample Size: Not applicable. No clinical test set data was provided or used for evaluation in this 510(k) submission.
Data Provenance: Not applicable. No clinical data was used. The submission relies on non-clinical testing and comparison to legally marketed predicate devices.

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

Not applicable. No clinical test set was used, therefore no experts were required to establish ground truth for clinical performance. The assessment was based on FDA reviewers evaluating the non-clinical data and predicate device comparisons.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "Clinical Testing: None provided."

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

Not applicable. This is a bone graft substitute, not an AI algorithm or diagnostic device.

7. The Type of Ground Truth Used

Non-Clinical Data: The "ground truth" for the non-clinical testing (elemental analysis, set time, X-ray diffraction, surface pH, exothermic temperature) would be established by standard laboratory methods and specifications for biomaterials.
Substantial Equivalence: The primary "ground truth" for regulatory acceptance in this case is the established safety and effectiveness of the legally marketed predicate devices to which the OSS Bone Graft System is deemed "substantially equivalent." This means that the predicate devices, having gone through their own clearance processes (which may or may not have involved clinical trials depending on their regulatory pathway), served as the benchmark.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

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