(27 days)
NovaBone Porous - Synthetic Bone Graft Scaffold is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Porous 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
NovaBone Porous is an osteoconductive bioactive device. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. On implantation, NovaBone Porous undergoes a timedependent surface modification, resulting in the formation of a calcium phosphate layer on the device surfaces. The device acts as a scaffold, with new bone infiltrating the porous structure. NovaBone Porous is progressively resorbed and replaced by new bone tissue during the healing process.
The provided document describes a Special 510(k) submission for a device modification, specifically for the NovaBone Porous - Synthetic Bone Graft Scaffold. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics for a de novo approval or a clinical trial.
Therefore, much of the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, and ground truth establishment, as typically found in clinical studies, is not available in this document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The submission is for a device modification (packaging change) and relies on substantial equivalence to a predicate device, not on meeting new performance acceptance criteria through a specific study in the document.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. No specific "test set" in the context of device performance evaluation (e.g., clinical trial data) is mentioned.
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 in the document.
4. Adjudication method for the test set:
This information is not provided in the 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:
This information is not provided in the document. The device is a bone graft scaffold, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not provided in the document. The device is a physical bone graft scaffold.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document.
Summary of available information from the document that is relevant to the device and its claims:
- Device Name: NovaBone Porous - Synthetic Bone Graft Scaffold
- Device Modification: Inclusion of a syringe package format for material preparation and delivery. The implant material itself is unmodified.
- Claim: The device modification does not result in a change in technological characteristics of the device and it continues to be safe and effective.
- Predicate Device (Primary): NovaBone Porous - Bone Graft Scaffold [K060432]
- Predicate Device (Syringe format): NovaBone-AR [K041613] and NovaBone Putty [K082672, K080009]
- Intended Use: Indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., extremities and pelvis). These defects may be surgically created or from traumatic injury. Provides an osteoconductive scaffold that resorbs and is replaced with bone during the healing process.
- Technological Characteristics: Identical to the predicate NovaBone Porous (K060432), and similar to NovaBone Putty and NovaBone-AR predicates. It is a single-phase bioactive glass (45S5 Bioglass®) device.
- Conclusion of the Submission: The device, with the new syringe packaging, is substantially equivalent to legally marketed predicate devices.
The document is a regulatory submission focused on demonstrating substantial equivalence for a minor device modification (packaging), not on reporting results from a study designed to meet specific performance acceptance criteria for a novel 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.