(90 days)
NovaBone Resorbable Bone graft substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, 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® is a synthetic resorbable osteoconductive bone graft substitute particulate entirely composed of a calcium phospho-silicate material. The inorganic calcium and phosphorous components are thermally incorporated in a sodium silicate network designed specifically for its resorbability and osteoconductive nature. NovaBone is progressively resorbed and replaced by host bone during the healing process
The provided text describes NovaBone®, a resorbable bone graft substitute, and its substantial equivalence to predicate devices based on pre-clinical studies. It does not contain information about acceptance criteria in the typical sense of quantitative metrics for clinical performance, nor does it describe a study involving human readers or expert panels.
Here's a breakdown of the requested information based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than meeting specific quantitative performance metrics like sensitivity or specificity. The reported performance focuses on comparative biological responses in animal models.
| Acceptance Criteria (Demonstrated Substantial Equivalence to Predicates) | Reported Performance of NovaBone |
|---|---|
| Intended Use: Non-structural osteoconductive bone void filler for osseous defects. | Same as predicate devices. |
| Indications: Bony voids or gaps of the skeletal system (extremities, spine, pelvis). | Same as predicate devices. |
| Application: Gently packed into defect sites as a non-structural scaffold for healing. | Same as predicate devices. |
| Material: Inorganic calcium phospho-silicate. | Different from predicates (Bioglass®) but functionally similar for osteoconduction. |
| Device Action: Ion diffusion/exchange leads to calcium phosphate surface layer, acting as osteoconductive scaffold; material resorption. | Functions as described, similar to predicates in effect. |
| Performance (Bone Infiltration): Bone infiltration via osteoconduction, leading to increased graft site mechanical stiffness and strength. | Similar to predicate devices; new bone formation greater than predicates in some studies. Biomechanical properties similar to predicates. |
| Bone Remodeling: New bone grows, material absorbed and replaced by host bone. | Similar to predicate devices. |
| Resorption Rate: Majority absorbed by six months. | Similar to Pro Osteon 500R (slower than Wright Plaster of Paris Pellets, but still "substantially absorbed" within six months, consistent with bone remodeling). |
| Biocompatibility: Biocompatible, non-antigenic. | Similar to predicate devices. No evidence of local or systemic adverse effects observed in studies. |
| Mechanical: Particulate, not intended for load-bearing defects without fixation. | Similar to predicate devices. |
| Sterility: ETO sterilization. | Different from predicates (Gamma) but achieves sterility. |
| Voluntary Standards Met: Trace element levels as cited in ASTM F 1538-94. | Met specific ASTM standard; predicates had "None known." |
2. Sample size used for the test set and the data provenance
- Test Set (Pre-clinical Studies):
- Study A (NovaBone vs. ProOsteon 500R): Rabbits. The exact number of rabbits is not specified, but it refers to "the same animal" for comparison, implying a paired study design. The defect was 6mm in diameter in the distal femur.
- Study B (NovaBone vs. Wright Plaster of Paris Pellets): Goats. The exact number of goats is not specified. The defect was 10mm in diameter in the distal femur.
- Study C (NovaBone vs. Wright Plaster of Paris Pellets): Sheep. The exact number of sheep is not specified. Unicortical defects and a reamed channel in the iliac crest.
- Data Provenance: The studies are pre-clinical animal studies. The country of origin for the studies is not specified in the provided text, but it's presumed to be conducted by or for NovaBone Products, LLC (based in Alachua, FL, USA). The data is retrospective in the sense that it was collected prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The studies are pre-clinical animal studies evaluating biological response (e.g., residual graft material, new bone formation, biomechanical properties) which are typically assessed through objective measurements and histological analysis by trained researchers or pathologists, rather than expert consensus on image interpretation. The text does not specify the number or qualifications of experts involved in the assessment.
4. Adjudication method for the test set
Not applicable. The assessment of animal study results (histology, biomechanics) does not involve an adjudication method like 2+1 or 3+1, which are typically used for establishing ground truth in human image interpretation studies.
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
No. This is a medical device for bone graft substitution, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a medical device for bone graft substitution, not an algorithm.
7. The type of ground truth used
The "ground truth" in these pre-clinical animal studies was established through objective measurements and histological analysis of tissue samples from the defect sites. This includes assessment of:
- Residual graft material area
- Biomechanical properties of the graft site
- New bone formation (histologically)
8. The sample size for the training set
Not applicable. This is a manufactured medical device, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. 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.