(107 days)
The Bio2 CLM-BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bio2 CL.M+BG Bioacive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremitics 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.
The Bio2 Technologies implants are bone void fillers in the shape of cylinders, blocks and wedges. The devices are osteoconductive, bioactive, bone void fillers. The implants are made from a fiber based bioactive glass. The device structure allows tissue infiltration between the bioactive glass fibers. The fibers then are slowly absorbed and replaced by new bone tissue during the healing process. The cylinders, blocks and wedges are provided sterile and are intended for single use.
The provided document describes the Bio2 CLM.BG Bioactive Scaffold, a bone void filler device, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria with detailed performance metrics. Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test sets, expert qualifications, and detailed statistical analysis, are not present.
However, based on the information provided, here's a best effort to address the questions:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices and the successful outcomes of in vitro and in vivo studies, generally demonstrating that the Bio2 CLM.BG Bioactive Scaffold is as safe and effective as the control material and predicate devices. No specific quantitative acceptance criteria (e.g., minimum sensitivity or specificity values) are explicitly stated for diagnostic performance, as this is a bone void filler, not a diagnostic device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Properties: | |
| Biocompatible | Yes (established according to ISO-10993) |
| Forms hydroxyapatite (HA) in Simulated Body Fluid (SBF) solution | Yes (confirmed by in vitro bioactivity testing, ISO 23317:2012) |
| Radiopaque | Yes (stated as a characteristic) |
| Synthetic and non-collagenous | Yes (stated as a characteristic) |
| Functional Performance (Animal Study): | |
| Resorbs and forms bone in critical size defect model | Yes (demonstrated in rabbit femur critical size defect model at 8 and 16 weeks with x-ray, histology, histomorphometry; shown to be as safe and effective as the control material and predicate devices - NovaBone). Resorption and replacement by new bone tissue during healing process. |
| Safety and Effectiveness: | |
| As safe and effective as the predicate devices | Yes (conclusion based on in vitro and in vivo data, and comparison of technological characteristics) |
| Complies with ASTM F-1538 | Yes (stated compliance) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions "critical size defects were filled with Bio2 CLM.BG Bioactive Scaffold and the control material" in a rabbit model. However, the specific number of animals or defects in this in vivo study is not provided.
- Data Provenance: The in vivo study was an animal study (rabbit model), making it prospective pre-clinical data. The country of origin is not specified but assumed to be where Bio2 Technologies (Woburn, Massachusetts, USA based) conducted its research.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The assessment of the animal study results involved "x-ray, histology, histomorphometry, SEM and EDX," which would typically be evaluated by experts in those fields (e.g., veterinary radiologists, histopathologists), but their number and qualifications are not detailed.
4. Adjudication method for the test set
This information is not provided. For animal studies involving multiple assessment methods, adjudication among experts might occur, but no specific 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 is not applicable here. This document describes a medical device (bone void filler) and its substantial equivalence, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no mention of human reader improvement with or without AI assistance.
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 physical bone void filler, not an algorithm.
7. The type of ground truth used
The ground truth for the in vivo animal study comprised:
- Radiographs (x-ray): Imaging assessment of bone formation.
- Histology: Microscopic examination of tissue.
- Histomorphometry: Quantitative analysis of tissue structure (e.g., amount of new bone, scaffold resorption).
- SEM (Scanning Electron Microscopy) and EDX (Energy-Dispersive X-ray Spectroscopy): Advanced imaging and elemental analysis of material integration and new bone formation.
For the in vitro studies, the ground truth for apatite layer formation in SBF was measured via established scientific methods.
8. The sample size for the training set
This information is not provided and is generally not applicable in the context of a physical medical device (bone void filler) which typically undergoes pre-clinical and clinical testing, not "training" in the machine learning sense.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for this type of medical device as outlined in point 8.
§ 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.