(213 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 (i.e. the extremities 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.
BioSphere Putty is an osteoconductive, bioactive bone void filler that, like its predicate device (NovaBone), is composed of 4555 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.
The provided document is a 510(k) summary for the BioSphere™ Bioactive Bone Graft (BioSphere Putty) and its FDA clearance letter. It describes the device, its intended use, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria and the results of a study that directly proves the device meets those specific quantitative acceptance criteria.
The performance data section describes several tests performed, but it lacks specific quantitative acceptance criteria and detailed results to compare against them. Instead, it concludes with a statement that "Performance data demonstrate that BioSphere Putty is as safe and effective as the predicates."
Therefore, I cannot populate the table or answer all the questions as requested because the specific, quantitative acceptance criteria and the detailed study results directly comparing the device's performance against these criteria are not present in the provided text.
Here is what I CAN extract and infer from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in quantitative terms. The primary acceptance criterion appears to be "substantial equivalence" to predicate devices, meaning it is "as safe and effective" and "raises no new issues of safety or effectiveness."
- Reported Device Performance:
| Test | Performance |
|---|---|
| Material Compliance | Primary component (45S5 bioactive glass) complies with ASTM F-1538. |
| Biocompatibility | Testing in accordance with ISO 10993 demonstrated materials are biocompatible. |
| Compositional/Physical Comparison | XRF, particle size analysis, and ion dissolution showed the bioactive glass component was identical to the predicate device (NovaBone). |
| In vitro Bioactivity | The bioactive glass particles were capable of forming a calcium phosphate layer when incubated in simulated body fluid. |
| In vivo Performance (Animal Model) | Performance in a clinically relevant animal model showed bone formation similar to the predicate device. (Note: Results have not been correlated to clinical performance.) |
| Overall Conclusion (Substantial Equivalence) | BioSphere Putty is as safe and effective as the predicate devices. It has the same intended uses and similar indications, technological characteristics, and principles of operation. The minor technological differences (spherical particles, inert carrier) raise no new issues of safety or effectiveness. Performance data demonstrate BioSphere Putty is as safe and effective as the predicates. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Animal Model): Not specified.
- Data Provenance: Not specified for the animal model or in vitro testing. The submission is from Synergy Biomedical, LLC, located in Phoenixville, PA, USA, implying the company is US-based.
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)
- This device is a bone void filler, not an AI/imaging device that requires expert review for ground truth. Therefore, this information is not applicable and not present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an expert-adjudicated test set in the context of AI/imaging.
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
- No. This is a medical device (bone void filler), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as this is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For in vitro tests: Chemical analysis (XRF, particle size, ion dissolution), observation of calcium phosphate layer formation in SBF.
- For in vivo tests (animal model): Observation and assessment of "bone formation similar to the predicate device." The method of assessing bone formation (e.g., histology, imaging) and the ground truth standard for "similar" are not detailed.
8. The sample size for the training set
- Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/machine learning 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.