(191 days)
Bioactive Bone Graft Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Bioactive Bone Graft Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). Bioactive Bone Graft Putty can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules and bioactive glass granules suspended in a resorbable polymer carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.
Here's a breakdown of the acceptance criteria and study information for the Bioactive Bone Graft Putty, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a submission for a medical device (Bioactive Bone Graft Putty) seeking 510(k) clearance, which means demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" are implicitly the requirements for demonstrating substantial equivalence. The reported "device performance" refers to the results of the studies used to support this equivalence.
| Category | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Material Characterization | Meet ASTM standards for raw materials: F1538-03, F1185-03, F1088-04a, F1929/F1926M, and USP NF. | Performed as applicable. (Specific results not detailed, but implied to meet standards). |
| Biocompatibility | Demonstrate biocompatibility and non-toxicity according to ISO 10993 for a long-term implant product. | Device is biocompatible and non-toxic. |
| Packaging | Meet ISO 11607, ASTM F2096-11, F88-09, and F1929-98. | Testing performed. (Specific results not detailed, but implied to meet standards). |
| Sterilization | Meet ISO 11137. | Testing performed. (Specific results not detailed, but implied to meet standards). |
| Shelf Life | Meet ASTM F1980. | Testing performed. (Specific results not detailed, but implied to meet standards). |
| Bioactivity (in vitro) | Show apatite layer formation on the surface of the implant following immersion in simulated body fluid (SBF). | Demonstrated apatite layer formation. (Note: These results have not been correlated to clinical performance). |
| In vivo Performance | Demonstrate equivalent safety, graft resorption, and new bone formation compared to a predicate device in relevant animal models (femoral cancellous defect and posterolateral spine fusion). | The test results showed equivalent in vivo performance in safety, graft resorption, and new bone formation when compared to a predicate device in rabbit models. |
| Technological Equivalence | Demonstrate that technological differences (e.g., material composition) do not raise new issues of safety or effectiveness. | The technological differences presented by the composition of materials do not raise new issues of safety or effectiveness, as demonstrated by side-by-side evaluation in animal performance studies. |
| Intended Use | Same intended use as predicate devices: bone void filler in bony voids/gaps not intrinsic to stability, including surgically created or traumatic defects, extremities, pelvis, and posterolateral spine fusion; can be used with autograft as a bone graft extender; resorbed and replaced with host bone. | Bioactive Bone Graft Putty has the same intended use as all the predicate devices. |
| Principles of Operation | Same principles of operation as predicate devices: serve as osteoconductive matrices for new bone formation. | Bioactive Bone Graft Putty has the same principles of operation as all the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states "Animal performance testing was performed in femoral cancellous defect and posterolateral spine fusion (PLF) rabbit models." It does not specify the exact number of rabbits used in these models.
- Data Provenance: The animal studies were performed in "rabbit models." This indicates a pre-clinical, prospective study design, typically conducted in a controlled laboratory environment. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the text. The animal studies would typically involve veterinary pathologists or researchers to assess outcomes (e.g., new bone formation, graft resorption), but the number and qualifications of such experts are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the text. Given the nature of animal studies assessing histological or radiographic outcomes, there might have been independent assessment by experts, but the adjudication method (e.g., 2+1, 3+1) is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. This type of study typically involves human readers interpreting medical images or data, which is not applicable to the animal performance testing described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a bone graft putty, not an algorithm or an AI-powered diagnostic tool. The concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used
For the animal performance testing, the ground truth was established through direct observation and histopathological assessment of the animal models. This would include:
- Histopathology: Examining tissue samples under a microscope to evaluate new bone formation, graft resorption, and inflammatory reactions.
- Radiographic imaging (implied): While not explicitly stated for confirming the "outcome" in the way pathology would, it's common in bone healing studies to use imaging to track progress. However, the direct measure for bone formation and resorption would largely rely on pathology.
8. The Sample Size for the Training Set
This is not applicable for this device. The Bioactive Bone Graft Putty is a physical medical device, not an AI model requiring a training set. The "testing" mentioned refers to traditional pre-clinical and bench testing.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no AI model or "training set" for this 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.