(124 days)
NovaBone Putty - Bioactive Synthetic 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 extremitics, 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. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NoyaBone Putty must not be used to gain screw purchase or to stabilize screw placement.
NovaBonc 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 are slowly absorbed and replaced by new bone tissue during the healing process.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the NovaBone Putty - Bioactive Synthetic Graft:
The provided 510(k) summary is for a medical device (NovaBone Putty) seeking substantial equivalence to a legally marketed predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a predicate, rather than establishing entirely new performance criteria through extensive clinical trials. Therefore, the information provided focuses on equivalence rather than detailed acceptance criteria and studies demonstrating absolute performance against novel benchmarks.
Crucially, this document does not contain the kind of detailed acceptance criteria, study data, ground truth establishment, or multi-reader multi-case studies typically associated with AI/CADe devices or new clinical effectiveness studies.
Instead, it describes the device, its intended use, and argues for substantial equivalence based on technological characteristics and animal in vivo performance data.
Analysis of Provided Information:
Based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for substantial equivalence based on technological similarity and in vivo performance (animal studies), there isn't a table of explicit acceptance criteria and corresponding reported performance that you might find for a diagnostic device or a new therapeutic.
However, the key "acceptance criteria" for a 510(k) submission on the part of the FDA are that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (from submission) |
|---|---|
| Substantial Equivalence: | Claimed to be substantially equivalent to NovaBone Putty (K060728) and NovaBone (K021336, K052494) predicate devices. |
| - Technological Characteristics: | Identical primary component (45S5 Bioglass particulate) to NovaBone predicate. Includes synthetic binder. |
| - Intended Use: | Same intended use as predicates: bony voids/gaps not intrinsic to stability, gently packed into skeletal system (extremities, spine, pelvis). Non-load-bearing. Not for vertebroplasty/kyphoplasty. |
| - Biocompatibility: | Bioactive glass (45S5 Bioglass) is biocompatible. Binder is biocompatible. |
| - Osteoconductivity: | Bioactive glass (45S5 Bioglass) is osteoconductive. |
| - Resorption & Bone Replacement: | Particles are slowly absorbed and replaced by new bone tissue during healing. |
| - Rate of Absorption (Animal Data): | Majority absorbed within 6 months, >98% absorbed by 12 months (in animals). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (In vivo performance data): The document mentions "In vivo performance data were presented in support of the requested expansion of device claims." However, it does not specify the sample size, species, or country of origin for these in vivo studies. It only states that "Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the material being absorbed by 12 months." This suggests animal data, retrospective or prospective is not specified, but typically animal studies would be prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This type of information is usually relevant for diagnostic devices where expert consensus or pathological review establishes a "ground truth" for disease presence or absence. For a bone graft material, the in vivo performance is observed through histology, imaging, and gross examination in animal models, not typically via expert medical reviewer consensus on images to establish "ground truth" in the diagnostic sense. The "experts" would likely be veterinarians, pathologists specializing in bone, or orthopedic researchers involved in the animal studies. Their qualifications are not stated in this document.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, there isn't an "adjudication" of expert opinions in the context of device performance in animal models described here. The animal study results would be evaluated based on scientific methodologies and statistical analysis of objective measurements (e.g., bone formation, material resorption).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not mentioned as this device is a bone void filler material, not a diagnostic aid that assists human readers in interpreting images. Therefore, there is no effect size reported for human readers with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical bone graft material, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used:
- For the in vivo performance data (animal testing), the ground truth would be based on histological analysis, imaging (e.g., X-ray, micro-CT), and gross observation of bone formation and material resorption in the animal models. These are objective measures taken from the tissue samples or imaging over time.
8. The Sample Size for the Training Set:
- Not Applicable. This document describes a physical medical device, not an AI or machine learning model that would have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As per point 8.
Summary Limitations:
It is important to reiterate that this 510(k) summary is designed to demonstrate "substantial equivalence" to existing, legally marketed devices. It focuses on comparing the new device's characteristics and intended use to those predicates, and supporting claims with basic biological performance data (primarily animal studies for absorption). It is not a clinical trial report or a performance study for a diagnostic AI device, which would typically contain the specific criteria and study details requested in your prompt.
§ 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.