(773 days)
Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone 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. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
OsteoCrete™ is an injectable, moldable, and biocompatible Bone Void Filler. The OsteoCrete™ Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
The provided text describes the OsteoCrete™ Bone Void Filler and its 510(k) submission but does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding the test set, expert involvement, or statistical methods typically associated with AI/ML device evaluations.
The relevant section in the document states:
"OsteoCrete™ Bone Void Filler was subjected to performance testing Performance Data: (bench and animal) in accordance with the FDA Guidance Document, 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler; Guidance for Industry and FDA.' The testing confirmed substantial equivalence to the predicate device."
This indicates that the device underwent non-clinical performance testing (bench and animal studies) to demonstrate substantial equivalence to predicate devices, as per FDA guidance for this type of medical device (resorbable calcium salt bone void filler). These types of devices are not typically AI/ML-driven, and therefore, the information requested in your prompt regarding AI/ML study design (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this 510(k) submission.
Therefore, I cannot populate the table or answer the specific questions below with the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the text for this non-AI/ML device. | Not provided in the text for this non-AI/ML device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission focusing on bench and animal testing for substantial equivalence, not a clinical study involving a test set of data with human-in-the-loop or standalone AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission focusing on bench and animal testing for substantial equivalence, not a clinical study involving experts establishing ground truth for data for AI/ML validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission, not an AI/ML study requiring adjudication methods for a test set.
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. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission. MRMC studies are specific to evaluating human reader performance with and without AI assistance, which is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Standalone algorithm performance is relevant to AI/ML devices, not to this product.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). "Ground truth" in the context of AI/ML validation is not relevant here. The "performance data" mentioned refers to bench and animal testing results demonstrating physical and biological properties.
8. The sample size for the training set
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Training sets are relevant to AI/ML model development, not to this product.
9. How the ground truth for the training set was established
Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Training set ground truth is relevant to AI/ML model development, not to this product.
§ 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.