(54 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 intervertebral disc space). 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 process. When used in intervertebral disc space, NovaBone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
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 - Bioactive Synthetic Bone Graft 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. 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. The mixed device is supplied sterile and is provided in a PETG tray, disposable plastic syringe, or a prefilled cartridge delivery system (MIS delivery system).
The provided text is a 510(k) summary for the NovaBone Putty - Bioactive Synthetic Bone Graft. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new, innovative device that requires extensive clinical validation. Therefore, many of the requested elements for describing acceptance criteria and proving device performance through a study (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods) are not explicitly detailed in this type of regulatory submission.
However, based on the information provided, here's what can be inferred and stated regarding the device's acceptance criteria and the "study" (or rather, the justification for substantial equivalence):
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of precise quantitative acceptance criteria in the format typically seen for a new device's efficacy or safety trial. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is essentially the claim that the NovaBone Putty exhibits functional characteristics similar to the predicate devices and meets general safety and efficacy requirements for this class of device.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Intended Use | Same intended use as predicate devices. |
| Indications for Use | Same specific indications for use in the intervertebral body spine as predicate devices. Expands previous indications to include intervertebral disc space. |
| Material Composition | Similar material composition to predicate. Differences are addressed by prior functional animal model performance. |
| Osteoconductivity | Designed as an osteoconductive space-filling material. |
| Resorption & Replacement | Slowly absorbed and replaced by new bone tissue during healing. |
| Safety & Effectiveness | Differences in technological characteristics do not raise different questions of safety and effectiveness. Supported by prior functional animal model performance and existing data for predicate/reference devices. |
| Sterility | Leveraged from previously cleared devices (K240404, K082672). |
| Shelf-life | Leveraged from previously cleared devices (K240404, K082672). |
| Endotoxin | Leveraged from previously cleared devices (K240404, K082672). |
| Pyrogenicity | Leveraged from previously cleared devices (K240404, K082672). |
| Biocompatibility | Leveraged from previously cleared devices (K240404, K082672). |
| Bench Performance | Leveraged from previously cleared devices (K240404, K082672), as recommended in FDA's Class II Special Controls Guidance Document. |
| Performance in Intervertebral Body Space | Supported by a robust analysis of bone grafting materials in prior posterolateral spine fusion studies. |
2. Sample sized used for the test set and the data provenance:
The document does not describe a "test set" in the context of a prospective clinical trial with a defined sample size for the current submission. Instead, it relies on:
- Prior functional animal model performance: This data provenance is mentioned to address differences in material composition. The specific sample size for this animal model is not provided.
- Previously cleared devices (K240404, K082672): Data for sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and bench performance are leveraged from these reference devices. The original sample sizes for these tests are not provided in this summary.
- Prior posterolateral spine fusion studies: Mentioned to support performance in the intervertebral body space. No specific sample size or provenance for these studies is given.
Given this is a 510(k) submission, the data is likely a combination of pre-clinical (animal) data, bench testing, and potentially existing clinical data from predicate or reference devices, rather than a new, large-scale prospective clinical study specifically for this submission. The provenance (country of origin, retrospective/prospective) is not detailed for these underlying studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Since no new clinical "test set" requiring expert ground truth establishment is described for this submission, these details are absent. The FDA's review process inherently involves experts, but not in the context of establishing ground truth for a discrete test set for the device's performance in this document.
4. Adjudication method for the test set:
Not applicable, as no described new clinical test set requiring adjudication is presented in this document.
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. The NovaBone Putty is a medical implant (bone graft) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The NovaBone Putty is a medical implant, not an algorithm.
7. The type of ground truth used:
For this 510(k) submission, the "ground truth" for the device's substantial equivalence is established by regulatory standards and existing data on the predicate devices. The safety and effectiveness claims are based on:
- Functional animal model performance data: This would typically involve histological analysis, biomechanical testing, and potentially imaging to assess bone regeneration.
- Previous characterization, bench performance, and biocompatibility studies: These tests follow recognized standards and guidance documents (e.g., ISO standards for biocompatibility (pathology), ASTM standards for material properties (bench data)).
- Clinical experience with predicate and reference devices: The FDA considers the established safety and efficacy profile of the legally marketed predicate device as part of the ground truth for substantial equivalence.
8. The sample size for the training set:
Not applicable. The NovaBone Putty is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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.