(130 days)
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 or 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. The device is slowly absorbed during graft site healing.
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 is provided in three basic forms: loose granules, a composite plug and a composite block.
The provided document is a 510(k) summary for the NovaBone MacroFORM BIOACTIVE bone graft devices. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and performance.
However, the document does not contain the kind of information typically found in studies designed to establish specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or to quantify improvement with an AI system. This document is a regulatory submission focused on demonstrating substantial equivalence, not on detailed performance analysis against a set of quantitative acceptance criteria in the way you've framed the request.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the way you've outlined, according to the provided text. The information required for points 1-9 (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set sample size, how training ground truth was established) is absent from this regulatory document.
Summary of what can be gleaned from the document regarding performance:
- Device Performance Claim: The document states that "Functional in vivo testing in an animal model (rabbit tibia defect) was performed on MacroFORM using the primary predicate (K090731, NovaBone Porous) as a control. The results demonstrate that bone remodeling process for MacroFORM is equivalent to that of NovaBone Porous."
- Acceptance Criteria (Implicit): The implicit acceptance criterion appears to be "equivalence" in bone remodeling to the predicate device (NovaBone Porous) in the specified animal model. No specific quantitative metrics (e.g., percentage of bone fill, density, etc.) are provided as acceptance thresholds.
- Study Details:
- Type of Study: Functional in vivo testing in an animal model.
- Model: Rabbit tibia defect.
- Comparison: MacroFORM was compared to the primary predicate, NovaBone Porous (K090731), as a control.
- Ground Truth: The "bone remodeling process" was assessed, but the method of assessment (e.g., histology, imaging, quantitative measures) and how ground truth was established are not detailed.
- Sample Size: Not specified for the animal study.
- Training Set/AI Specifics: Not applicable as this is not an AI/software device.
- Adjudication/Experts/MRMC: Not applicable.
In conclusion, while the document confirms a study was done for in vivo performance and biocompatibility to support substantial equivalence, it does not provide the granular details relevant to an AI/diagnostic device's acceptance criteria and validation study as requested.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.