(42 days)
NovaBone Porous - 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 text describes a 510(k) premarket notification for "NovaBone Porous - Bone Graft Scaffold." It includes information about the device's characteristics, intended use, and a conclusion based on an in vivo study. However, it does not explicitly detail specific quantitative acceptance criteria or the full results of a study that directly prove the device meets such criteria in a comparative manner.
Let's extract the available information and highlight what is missing based on your request.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct performance metric that is compared against a pre-defined threshold. The "conclusion" states the findings of an in vivo study, which serves as the reported device performance.
| Acceptance Criteria (Not explicitly stated as quantitative) | Reported Device Performance (from in vivo study) |
|---|---|
| Evidence of osteoconductive nature | Demonstrated new bone formation at early post-implantation periods |
| No local or systemic adverse effects related to the device | No evidence of local or systemic adverse effects observed |
| Biocompatibility | Supported by additional in vitro data (details not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions an "in vivo study data" and "additional supporting in vitro data."
- Sample Size for Test Set: Not specified for the in vivo study.
- Data Provenance: The in vivo study is implied to be pre-clinical (likely animal studies, given the nature of the device and the typical regulatory pathway for such products), but the specific country of origin or whether it was retrospective or prospective is not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned. The document only states that "in vivo study data were presented supporting the osteoconductive nature." This suggests a scientific evaluation, but specific adjudication processes are not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. This type of study is typically performed for diagnostic or screening devices where human readers interpret results, often with and without AI assistance. This device is a bone graft scaffold, not a diagnostic tool requiring human interpretation of images or other data in this context.
- Effect Size of Human Readers (with vs. without AI assistance): Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Standalone Performance Done?: Not applicable. This device is a physical bone graft, not an algorithm. The "performance" refers to its biological interaction with the body in vivo.
7. Type of Ground Truth Used
- Ground Truth: The in vivo study data likely used histopathological examination and clinical observation/imaging as the ground truth to assess "new bone formation" and "local or systemic adverse effects." The document does not explicitly state "pathology" but it is strongly implied by the nature of in vivo studies for bone regeneration.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not a machine learning algorithm that requires a "training set" in the computational sense. The product development process involves iterative testing and refinement, but not a formal "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Establishing Ground Truth for Training Set: Not applicable. As above, there is no "training set" in the context of an AI algorithm described for this device.
Summary of Missing Information:
The document provides a high-level summary of an in vivo study used to support the device's efficacy and safety for a 510(k) submission. However, it lacks the detailed methodology, quantitative acceptance criteria, and specific metrics typically found in a comprehensive study report, especially those relevant to evaluating AI-powered devices (which this is not). The request's questions are heavily geared towards AI/software performance evaluations, which do not directly apply to this physical medical 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.