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510(k) Data Aggregation
(105 days)
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. 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.
BioSphere Putty Bioactive Bone Graft (BioSphere Putty) is an osteoconductive, bioactive bone void filler that, like its predicate device, is composed of 45S5 bioactive glass particles. In BioSphere Putty, the bioactive glass is mixed with an inert, moldable carrier that aids in placement of the product into bony voids. Upon implantation, the carrier is absorbed by the site and the remaining bioactive glass particles provide an osteoconductive surface for bone formation. The bioactive glass particles are provided in a spherical form, and the natural packing of the spheres creates 3-dimensional, interconnected porosity that allows for bone regeneration throughout the defect site. In the posterolateral spine, BioSphere Putty can be combined with autograft as a bone graft extender.
Here's a breakdown of the acceptance criteria and the study details for the BioSphere® Putty Bioactive Bone Graft, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly list quantitative "acceptance criteria" in the format of a target value. Instead, the primary performance measure for the expanded indication (bone graft extender in posterolateral spine) was to demonstrate substantial equivalence to autograft. This was assessed through various methods, with a focus on radiographic fusion rate and biomechanical similarity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Radiographic Fusion at 12 Weeks: Substantially equivalent to autograft in a rabbit posterolateral fusion model. | "The radiographic fusion rate for each group was determined from the 12-week x-rays and microCT images... The results showed that the device was similar to autograft at both time points." (indicating similar fusion rates) |
| Biomechanical Properties at 12 Weeks: Similar range of motion and tensile peak load to autograft in the rabbit model. | "Additionally at 12 weeks, spines were biomechanically tested in range of motion and tensile peak load. The results showed that the device was similar to autograft at both time points." (indicating similar biomechanical performance in both aspects) |
| Histological and Histomorphometric Evaluation at 6 & 12 Weeks: Demonstrate osteoconductivity and bone formation comparable to autograft. | "In the study, spines were evaluated at 6 and 12 weeks using x-ray, microCT, histology, and histomorphometry. ... The results showed that the device was similar to autograft at both time points." (While not explicitly stating quantitative similarity, the overall conclusion of "similar" implies meeting expectations for bone formation.) |
| Resorption and Replacement with Bone: Expected behavior for a bone void filler. | "The product provides a bone void filler that resorbs and is replaced with bone during the healing process." (This is part of the intended mechanism of action, reinforced by the "similar to autograft" findings.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Five (5) animals were evaluated at each time point (6 weeks and 12 weeks) for each group (BioSphere Putty + autograft and autograft only). This implies a total of 20 animals in the test set (5 animals/group * 2 groups * 2 time points).
- Data Provenance: The study was conducted using a rabbit posterolateral fusion model, which is an animal model. The text doesn't specify the country of origin for the data or whether it was retrospective or prospective, but animal studies are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: The text states that a "blinded, bilateral radiographic fusion assessment" was conducted to determine the radiographic fusion rate. However, it does not specify the number of experts who performed this assessment.
- Qualifications of Experts: The text does not specify the qualifications of the experts who performed the assessment.
4. Adjudication Method for the Test Set
- The text describes a "blinded, bilateral radiographic fusion assessment." This implies that the assessors were blinded to the treatment group (BioSphere Putty + autograft vs. autograft). However, the specific adjudication method (e.g., 2+1, 3+1, none) is not mentioned. It's unclear if multiple readers independently assessed and then reached consensus, or if a single reader performed the assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is an animal model study comparing the device to autograft. There is no mention of human readers assessing cases with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. The device is a physical bone graft, not an algorithm. The study assessed the in-vivo performance of the physical product.
7. Type of Ground Truth Used
The ground truth for the animal study was established through a combination of:
- Radiographic Assessment: X-ray and microCT images.
- Histology and Histomorphometry: Microscopic examination of tissue for bone formation and integration.
- Biomechanical Testing: Direct measurement of range of motion and tensile peak load.
This represents a comprehensive approach to defining "fusion" and material performance in an animal model.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here as the submission describes a physical medical device (bone graft), not a machine learning algorithm. Therefore, there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for an algorithm, this question is not applicable.
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