(447 days)
Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (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.
Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. When implanted in living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone mineral. The biological apatite layer of the granules provides an osteoconductive scaffold for the generation of new osseous tissue. New bone infiltrates around the granules allowing the repair of the defect as the granules are absorbed. The elemental composition of Interface Bone Void Filler granules is Si, Ca, Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.
The provided text describes the Interface Bone Void Filler and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (NovaBone Resorbable Bone Graft Substitute) through:
- Material Characterization: Comparing chemical composition, physical properties, and performance characteristics (e.g., dissolution rates).
- Animal Model Study: Comparing radiographic, morphometric, and histologic performance of the subject device to the predicate device in an animal model.
Therefore, I cannot provide the requested table or detailed study information for acceptance criteria related to AI/ML device performance.
However, I can extract information related to the equivalence study as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a physical medical device (bone void filler) and not an AI/ML device, the concept of "acceptance criteria" in the context of sensitivity, specificity, or similar metrics for an algorithm's performance is not applicable to the provided text. The "performance" assessment here is about demonstrating equivalence to a predicate device.
| Acceptance Criteria (for Equivalence) | Reported Device Performance (Interface Bone Void Filler) |
|---|---|
| Chemical Composition | Equivalent to predicate (NovaBone) via SEM/EDXA, ICP/OES |
| Crystallinity | Equivalent to predicate (NovaBone) via FT-IR, XRD |
| Physical Properties | Equivalent to predicate (NovaBone) via SEM, particle size laser diffraction |
| Dissolution Testing | Equivalent to predicate (NovaBone) by monitoring calcium concentration |
| Radiographic Performance | Equivalent to predicate (NovaBone) in animal model |
| Morphometric Performance | Equivalent to predicate (NovaBone) in animal model |
| Histologic Performance | Equivalent to predicate (NovaBone) in animal model |
| Intended Use | Same as predicate (NovaBone) |
| Design Principles | Same as predicate (NovaBone) |
| Technological Characteristics | Same as predicate (NovaBone) |
| Elemental Composition | Same (Si, Ca, Na, P) as predicate (NovaBone) |
| Particle Sizes | Similar to predicate (NovaBone) |
| Packaging & Sterilization | Similar to predicate (NovaBone) |
The following points (2-9) are not applicable to the provided document as it describes a physical bone void filler, not an AI/ML medical device. Therefore, the information regarding sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this text.
I can only state that:
- Sample size, data provenance: The document mentions an "animal model" for the performance comparison but does not specify the number of animals used or their origin. It is a prospective study in the sense that the sponsor conducted it to demonstrate equivalence.
- Number of experts and qualifications: Not applicable. Ground truth was established through scientific analysis (chemical, physical, animal model results).
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI performance with human readers.
- Standalone (algorithm only) performance: Not applicable. This is for AI performance.
- Type of ground truth: For the material characterization, it's based on analytical measurements (e.g., SEM/EDXA, ICP/OES, FT-IR, XRD, laser diffraction, calcium-specific electrode). For the animal study, it's based on radiographic, morphometric, and histologic assessments.
- Sample size for training set: Not applicable (no AI/ML algorithm involved).
- How ground truth for training set was established: Not applicable (no AI/ML algorithm involved).
§ 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.