(137 days)
NB3D Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is intended to be used in conjunction with bone marrow aspirate and autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. NB3D provides an open void/gap filler that resorbs and is replaced by the growth of new bone during the healing process.
NB3D is a resorbable porous, calcium phosphate bone void filler that provides a scaffold for the in-growth of new bone. NB3D is an osteoconductive implant with an interconnected porosity similar to human cancellous bone.
The provided document is a 510(k) summary for the Pioneer Surgical Technology NB3D Bone Void Filler. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing device performance data against specific acceptance criteria from a clinical study. Therefore, the document does not contain the detailed information requested regarding clinical study design, acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.
Instead, it relies on comparative testing and established standards to show that the new device is as safe and effective as existing ones.
Here's a breakdown of what is available and what is not available based on your request:
1. Table of acceptance criteria and the reported device performance:
- Not Available directly. The document does not specify quantitative acceptance criteria (e.g., success rates, sensitivity, specificity) for a clinical performance study. It states that characterization testing and animal testing were performed to demonstrate substantial equivalence to predicate devices.
- Reported performance (Indirectly): The document affirms that NB3D has "the same intended use," "uses the same operating principle," "incorporates the same basic design," "incorporates the same or very similar materials," and "has similar packaging and is sterilized using the same materials and processes" as the predicate devices. The implication is that its performance is equivalent to these already-cleared devices.
2. Sample size used for the test set and the data provenance:
- Not Available for human clinical data. The document mentions "Animal testing performed to demonstrate substantial equivalence ... in a rabbit posterolateral spine fusion model." The sample size for this animal study is not specified, nor is the country of origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available. This information pertains to human clinical studies or expert review processes, neither of which are detailed in this 510(k) summary.
4. Adjudication method for the test set:
- Not Available. As above, this is relevant for human clinical studies and not present in this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a bone void filler, not an AI/software-based diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. Again, this pertains to AI/software performance, not a bone void filler.
7. The type of ground truth used:
- Animal Model Observations/Assessments: For the animal study, the document states "determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device." These assessments served as the "ground truth" for evaluating the performance in that specific animal model.
8. The sample size for the training set:
- Not Applicable/Not Available. The concept of a "training set" is typically for machine learning algorithms. For a physical medical device like a bone void filler, there isn't a "training set" in this context.
9. How the ground truth for the training set was established:
- Not Applicable/Not Available. As with point 8, this question is not relevant for this type of device submission.
Summary of available information regarding the "study that proves the device meets the acceptance criteria":
The "study" cited is animal testing and characterization testing.
- Characterization testing: Included methods described in ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F1185. These are standards related to biocompatibility and material properties. The specific acceptance criteria within these standards are not detailed in the summary, but the implication is that the device met them.
- Animal testing: Performed "to demonstrate substantial equivalence included determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device in a rabbit posterolateral spine fusion model."
- Test set sample size: Not specified.
- Data provenance: "rabbit posterolateral spine fusion model" (animal study).
- Ground truth: Radiographic, biomechanical, and histological observations.
- Goal: To show equivalence to a predicate device (Vitoss Bioactive) in an animal model.
In essence, the 510(k) process for this device relies on demonstrating that it is "substantially equivalent" to already-approved devices through comparison of design principles, materials, intended use, and pre-clinical testing, rather than presenting a full clinical trial with defined acceptance criteria and performance statistics for human subjects.
§ 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.