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NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM is indicated to 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 created from traumatic injury to the bone. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone MacroFORM is an osteoconductive bioactive device used for grafting osseous defects. It is a composite of bioactive calcium-phospho-silicate granules and a collagen binder. The bioactive particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The collagen binder consists of bovine collagen. When mixed with bone marrow aspirate, the device forms a non-hardening graft that is applied directly to the intended graft site.

During absorption of the collagen binder, the particulate material remaining undergoes a time-dependent kinetic modification of the surface to stimulate osteoblast activity and guide the formation of bone across the graft site. Specifically, a series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. During healing, the graft particulate is absorbed and remodeled into new bone.

MacroFORM BIOACTIVE MIS is provided in an MIS Cartridge (tube) for delivery using the NovaBone MIS Cartridge Handle accessory, supplied separately. The graft formulation is identical to MacroFORM BIOACTIVE moldable composite (K140946, primary predicate). The MIS Cartridge/Handle system is equivalent to that of NovaBone Putty MIS (K112773, reference predicate).

This document is a 510(k) premarket notification for the NovaBone MacroFORM BIOACTIVE MIS, a resorbable calcium salt bone void filler device. The purpose of this notification is to establish substantial equivalence to legally marketed predicate devices, not to perform a new device study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically found in clinical trials or performance studies for AI/software devices, is not applicable to this regulatory submission.

This 510(k) submission primarily relies on demonstrating that the new device has "substantially equivalent" technological characteristics and intended use to existing predicate devices, and that it raises no new questions of safety or effectiveness.

Here’s a breakdown of why each requested point cannot be directly extracted from this document regarding a clinical performance study:

1. Table of acceptance criteria and the reported device performance:

• This document does not specify quantitative clinical acceptance criteria (e.g., bone healing rates, specific measures of defect fill) that the device would need to meet in a study. Its "performance" is assessed in terms of substantial equivalence to predicates.

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

• No clinical "test set" in the context of device performance is described. The document refers to a "hydration study" and "biocompatibility testing," which are engineering/materials tests, not clinical studies with patient data.

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

• Not applicable as there is no clinical test set or ground truth established by experts in this type of submission.

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

• Not applicable.

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:

• This device is a bone void filler, not an AI or imaging diagnostic device, so MRMC studies are not relevant.

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

• This is not an algorithm or AI device.

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

• Not applicable, as no clinical performance data requiring a ground truth determination is presented.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable.

What the document does provide in terms of device validation and comparison:

The document focuses on demonstrating substantial equivalence through:

• Identical Indications for Use: The indications for use for NovaBone MacroFORM BIOACTIVE MIS are identical to its primary predicate, NovaBone MacroFORM BIOACTIVE moldable composite (K140946).
• Identical Graft Formulation: The device has the same bioactive component (Bioglass® 45S5) and bovine collagen source as the primary predicate.
• Biocompatibility Testing: Testing (cytotoxicity, genotoxicity, intracutaneous irritation) was performed and passed for the graft in its new cartridge packaging format, mitigating risks associated with the packaging change.
• Hydration Study: A study was conducted to determine optimal hydration fluid amounts and setting times for the graft in the MIS Cartridge, leading to updated instructions for use.
• Accessory Handle Equivalence: The accessory handle is identical to that of a reference predicate (NovaBone Putty MIS, K112773), with only packaging graphics changed.
• Sterilization: The device is supplied sterile (SAL 10^-6) using irradiation, similar to predicates.

In summary, this 510(k) notification is a premarket submission demonstrating equivalence to existing devices, not a clinical study proving device performance against specific clinical acceptance criteria.

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