(90 days)
The BoneSource® BVF is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. The BoneSource® BVF is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e. 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.
BoneSource® BVF is an injectable, self-setting, calcium phosphate cement that is biocompatible and bioresorbable.
This is a 510(k) summary for a medical device called BoneSource® BVF, a bone void filler. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial for a novel AI/software device would.
Therefore, the requested information elements related to AI/software device performance studies, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this type of submission.
Here's an analysis of what is provided and a best effort to address the prompt given the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The concept of "acceptance criteria" and "reported device performance" in this 510(k) summary is centered around demonstrating substantial equivalence to existing predicate devices, rather than meeting specific quantifiable performance metrics. The implicit acceptance criteria are that the device shares the same fundamental characteristics and intended use as the predicate devices, and that any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance / Characteristics |
|---|---|
| Intended Use: Similar indications for use in treating bony voids/defects. | Intended for bony voids or defects not intrinsic to stability, placed into voids/gaps of the skeletal system (extremities, spine, pelvis). Resorbs and is replaced with bone. |
| Technological Characteristics: Similar materials, design, and operating principles. | Injectable, self-setting, calcium phosphate cement. Biocompatible and bioresorbable. |
| Materials: Composition comparable to predicate devices. | Calcium phosphate cement. (Specific composition not detailed, but implied to be similar to predicate HAC and SRS). |
| Safety: No new questions of safety. | Biocompatible. (Safety is implicitly established by substantial equivalence to legally marketed devices). |
| Effectiveness: No new questions of effectiveness. | Bioresorbable and replaced with bone during the healing process. (Effectiveness is implicitly established by substantial equivalence). |
2. Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) premarket notification demonstrating substantial equivalence, not a clinical study with a "test set" in the context of AI/software performance. The "test" here is a comparison to predicate devices based on design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are concepts within clinical studies, typically for diagnostic or predictive devices. This submission reviews device characteristics and intended use in comparison to predicates.
4. Adjudication method for the test set: Not applicable for the reasons stated above.
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/software device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.
7. The type of ground truth used: Not applicable. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices based on their prior market clearance and history of safe use.
8. The sample size for the training set: Not applicable. There is no "training set" in this context.
9. How the ground truth for the training set was established: Not applicable. There is no "training set" in this context.
§ 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.