(74 days)
Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), or in the posterolateral spine when mixed with autograft. 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. 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.
Here's a breakdown of the requested information based on the provided text, focusing on the study and acceptance criteria for the Interface Bone Void Filler:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a comparative equivalency study rather than a study with pre-defined acceptance criteria against specific performance metrics for the subject device alone. The goal was to demonstrate equivalence to a predicate device. Therefore, the "acceptance criteria" here implicitly refers to the demonstration of equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Chemical Composition Equivalence | The subject device (Interface Bone Void Filler) and predicate devices (Interface Bone Void Filler K092541 and NovaBone Resorbable Bone Graft Substitute K021336) were shown to have the same elemental composition (Si, Ca, Na, P). Chemical composition was analyzed by SEM/EDXA. Trace elemental analysis was performed by ICP/OES. Crystallinity was analyzed by FT-IR and XRD. |
| Physical Properties Equivalence | The subject device and predicate devices have similar particle sizes. Physical properties were evaluated by scanning electron microscopy, and particle size was determined by laser diffraction. |
| Performance Characteristics Equivalence (Dissolution) | Dissolution testing, monitoring calcium concentration with a calcium-specific electrode, demonstrated equivalent performance characteristics for the Interface Bone Void Filler and the NovaBone Resorbable Bone Graft Substitute devices. |
| Radiographic, Morphometric, and Histologic Performance | In a posterolateral spine fusion animal model, the radiographic, morphometric, and histologic performance of the subject Interface Bone Void Filler device was demonstrated to be equivalent to that of the predicate NovaBone device. (Note: Specific metrics for equivalence are not provided in this summary, only the general statement of equivalence) |
| Intended Use | The subject device has the same intended use as the predicate devices. |
| Operating Principle, Design, Materials, Packaging, and Sterilization | The subject device uses the same operating principle, incorporates the same basic design, incorporates the same or very similar materials, and has similar packaging and is sterilized using the same processes as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Physical/Chemical Testing: Not explicitly stated as a numerical sample size. The document mentions "detailed side-by-side material characterization was performed" and lists analytical methods. This implies sufficient samples were tested for each method to ensure accurate characterization.
- Sample Size for Animal Model: Not explicitly stated numerically. The text refers to "a posterolateral spine fusion animal model." More details (e.g., number of animals, number of implants per animal) would typically be in the full study report, but are absent in this summary.
- Data Provenance: Not explicitly stated (e.g., country of origin for the animal study, if it was retrospective or prospective). The animal model description suggests it was a prospective animal study conducted to compare the devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document extract. The summary mentions "radiographic, morphometric and histologic performance" in an animal model, which implies assessment by trained individuals (e.g., veterinary radiologists, pathologists), but their number or qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the given document extract. For the animal study's assessment of radiographic, morphometric, and histologic performance, no adjudication method (e.g., 2+1, 3+1) is described.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a comparison of two medical devices (bone void fillers) against each other, and it does not involve human readers interpreting images with or without AI assistance. This type of study is typically done for diagnostic imaging devices.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
This question is not applicable as the device is a bone void filler, not an AI algorithm. Therefore, an "algorithm only, without human-in-the-loop performance" study was not performed.
7. The Type of Ground Truth Used
For the animal model study, the "ground truth" was established by radiographic, morphometric, and histologic analyses. This implies:
- Radiographic: Interpretation of X-rays or other imaging by experts.
- Morphometric: Quantitative measurements of bone formation or other relevant structures from images or histological sections.
- Histologic: Examination of tissue samples under a microscope by pathologists to assess bone ingrowth, material resorption, inflammation, etc.
8. The Sample Size for the Training Set
This question is not applicable. The device is a bone void filler, not an AI algorithm, so there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for an AI algorithm.
§ 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.