(65 days)
NovaBone Putty - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. The mixed device is supplied sterile and is packaged in single-use containers in multiple formats. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process.
This 510(k) submission (K110368) is for a modification to an existing device, NovaBone Putty, specifically a change in packaging. Therefore, there are no acceptance criteria or a study detailed in the provided text that "proves the device meets the acceptance criteria" in the way a clinical trial might for a new device's performance.
Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, asserting that the change in packaging does not alter the device's fundamental characteristics or performance.
Here's an analysis based on your requested information, acknowledging the nature of this particular 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense for a device performance study. For a packaging modification, the "acceptance criteria" revolve around maintaining the safety, effectiveness, and technological characteristics of the original device. The "reported performance" is that the device itself remains unchanged and functions as intended, with the new packaging being stable and appropriate.
| Acceptance Criteria (Implied for Packaging Modification) | Reported Device Performance (as stated in submission) |
|---|---|
| Device's technological characteristics remain identical previously cleared predicate devices (K060728, K080009, K082672, K101860). | "The technological characteristics of the NovaBone Putty device of the current submission are identical to the NovaBone Putty device cleared per K060728, K080009, K082672, and K101860." The device itself is unchanged. |
| The device's intended use remains the same. | "The device indications are the same as for the predicate." |
| Packaging is suitable and does not compromise the device's sterility, integrity, or function. | "Information as to packaging validation is provided." (Details not explicitly in provided text, but implied to be sufficient for FDA clearance). |
| The device remains safe and effective as a non-structural osteoconductive bone void filler. | "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission is about a packaging change for an already cleared device. There is no "test set" in the context of evaluating a medical AI algorithm or a new therapeutic device's clinical performance. The "data provenance" would relate to the validation of the new packaging, which isn't detailed in this document but would typically involve material compatibility testing, sterility testing, and shelf-life studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth establishment for a patient-based test set is relevant for a packaging modification.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication process for clinical outcomes described.
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
Not applicable. This device is a bone void filler, not an AI diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical performance ground truth. For a packaging modification, the "ground truth" would be the verified physical and chemical properties of the device and packaging, and their interaction, as determined by laboratory testing and regulatory compliance.
8. The Sample Size for the Training Set
Not applicable. There is no training set for an AI algorithm or a new clinical device being developed from scratch.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.