(267 days)
NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® bone graft substitutes are intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
NanoBone consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxylapatite (HA) embedded in a highly porous silica gel matrix. The interconnected and open porous structure of NanoBone is similar to human cancellous bone. NanoBone is available as an irregular granulate.
The provided document describes the NanoBone® bone graft substitutes - NanoBone® | granulate device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing acceptance criteria for a novel device or an AI/ML powered device. Due to this, much of the requested information about AI model performance is not present in the document.
However, I can extract information related to the device's performance data and the studies performed to demonstrate its substantial equivalence as a medical device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a traditional medical device (bone graft substitute) and not an AI/ML powered device, "acceptance criteria" are related to meeting established standards and demonstrating equivalence to existing products, rather than metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance (NanoBone®) |
|---|---|---|
| Bench Testing | All relevant requirements for Calcium Salt Bone Void Fillers, including ASTM F1185 | Met: Products meet all relevant requirements, including ASTM F1185. |
| Material Characterization | Chemical/elemental composition, phase purity/XRD, dissolution characteristics | Characterized: Testing performed for chemical/elemental analysis, phase purity/XRD, and dissolution testing. (Specific results not detailed in this summary, but implied to be acceptable for equivalence). |
| Biocompatibility | Biocompatibility standards | Validated: Biocompatibility testing performed. (Specific results not detailed, but implied to be acceptable). |
| Sterilization | Sterilization validation standards | Validated: Sterilization validation performed. (Specific results not detailed, but implied to be acceptable). |
| In Vivo Performance | Radiographic, histologic, and histomorphometric characteristics comparable to controls in bone healing | Demonstrated: Animal testing showed substantial equivalence through determination of these characteristics in a critical-sized defect model. |
2. Sample size used for the test set and the data provenance
- Animal Testing (analogous to a test set for in-vivo performance):
- The document mentions "a critical-sized defect model in the sheep tibia."
- The sample size for the animal study (number of sheep or defects) is not specified in the provided text.
- Data Provenance: This was a prospective animal study. The country of origin is not explicitly stated, but the manufacturer is ARTOSS GmbH in Germany, suggesting it could have been conducted there or in a collaborating country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Ground truth for the animal study would have been established by methods such as radiographic analysis, histological examination, and histomorphometric analysis.
- The document does not specify the number or qualifications of experts (e.g., veterinary radiologists, pathologists) who established this ground truth.
4. Adjudication method for the test set
- The document does not specify an adjudication method for the animal study's assessments.
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
- Not applicable. This document is for a bone graft substitute, not an AI/ML powered device. Therefore, no MRMC study, human reader improvement with AI, or effect size is mentioned or relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical bone graft substitute, not an algorithm or AI/ML device.
7. The type of ground truth used
- For the in-vivo performance (animal study), the ground truth relied on direct biological and imaging evidence:
- Radiographic characteristics: Imaging used to assess bone healing.
- Histologic characteristics: Microscopic examination of tissue samples.
- Histomorphometric characteristics: Quantitative microscopic analysis of tissue structures.
- Controls: Autograft bone-filled defects (positive control) and empty unfilled defects (negative control) served as benchmarks.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML powered device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of 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.