(21 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. 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 packaged in single-use containers in multiple formats.
The device modification of the current submission packages the device in prefilled cartridges that are interchangeably attached to a dispensing handle. The length of the cartridges provides direct access application of the Putty to more remote defect sites.
This document is a 510(k) premarket notification for a modification to an existing medical device, NovaBone Putty. The modification specifically concerns the packaging (new pre-filled cartridges and dispensing handle) and not the material composition or intended use of the bone graft itself.
Therefore, the document does not contain information typically found in a study proving a device meets acceptance criteria related to its clinical efficacy or diagnostic performance. Instead, it demonstrates substantial equivalence to a predicate device based on material composition, intended use, and technological characteristics.
Here's an breakdown based on the provided text, addressing your questions where possible and indicating when the information is not present:
1. A table of acceptance criteria and the reported device performance
This document does not describe specific acceptance criteria and device performance metrics in the way one would for a new clinical or diagnostic device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device, which primarily relies on regulatory standards and comparison of attributes.
The core "performance" demonstrated is that the device modification (packaging) does not alter the fundamental characteristics or safety/effectiveness of the bone graft material itself.
| Acceptance Criteria (Implicit from 510(k) process for device modification) | Reported Device Performance / Characteristics |
|---|---|
| No change in material composition. | The primary component of NovaBone Putty is bioactive glass (45S5 Bioglass) particulate, mixed with a synthetic binder. The device material itself is unchanged from the predicate. |
| No change in intended use. | Indicated only for bony voids or gaps not intrinsic to bony structure stability. To be gently packed into bony voids or gaps of the skeletal system (extremities, posterolateral spine, and pelvis) due to surgically created osseous defects or traumatic injury. Provides a bone void filler that resorbs and is replaced with bone during healing. Not for load-bearing applications. These indications are the same as for the predicate. |
| No change in fundamental technological characteristics. | Osteoconductive, bioactive, bone void filler. Acts as a non-structural scaffold for natural healing and bone regeneration. Synthetic, inorganic, biocompatible, and osteoconductive scaffold. |
| Packaging modification improves access to remote sites. | The new cartridge-handle format provides improved access to remote graft sites. |
| No new safety concerns introduced by modification. | (Implicitly demonstrated by submission approval, no new testing results in the document to detail this, but it's a fundamental aspect of the 510(k) process). The FDA's letter states that they have "determined the device is substantially equivalent... to legally marketed predicate devices." |
| Continued biocompatibility. | Binder and bioactive glass are biocompatible. (Animal testing mentioned for absorption, but not new biocompatibility results for this submission). |
| Resorption and bone replacement. | Resorbs and is replaced with bone during the healing process. Animal testing demonstrated majority absorbed within 6 months, >98% by 12 months. This is a property of the material, not newly tested for this specific packaging modification. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission is for a packaging modification, not a clinical study involving a "test set" of patients or data in the typical sense. The document refers to "animal testing" for absorption but does not provide sample sizes or explicit details of the study for this specific submission; it refers to properties of the existing material.
- Data Provenance: Not applicable for a "test set" in this context. The "animal testing" referenced appears to be from previous submissions/data for the original material, not new data generated for this specific packaging modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" was established by experts for a clinical "test set" within this submission. The FDA's review process involves their own experts assessing the substantial equivalence.
4. Adjudication method for the test set
Not applicable. No "test set" or adjudication method 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 is not an AI-based device or a diagnostic device that would undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the clinical study sense. The "truth" for this submission is established through comparison to the predicate device and demonstration that the modification does not change material properties or intended use, evaluated against regulatory standards.
8. The sample size for the training set
Not applicable. No training set as this is not an AI device or a device requiring a new clinical trial.
9. How the ground truth for the training set was established
Not applicable. No training set.
§ 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.