(163 days)
NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is 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® SBX Putty consists of NanoBone granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone.
The provided text is a 510(k) summary for the medical device NanoBone® SBX Putty. It details the device's characteristics, intended use, and equivalence to predicate devices, and includes a section on performance data.
However, the provided text does not contain the information requested to answer the specific questions about acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop study for medical imaging. The document describes a traditional medical device (bone void filler) and its testing, which involves:
- Bench testing: Chemical/elemental analysis, phase purity/XRD, dissolution testing, sterilization validation, pyrogenicity testing.
- Biocompatibility assessment/testing.
- Animal testing: Using a critical-sized femoral condyle defect model in New Zealand white rabbits, with analysis via histology, histomorphometry, micro CT, and image analysis for new bone formation and product resorption.
This type of testing is characteristic of a substance or implantable material, not an AI-powered diagnostic device or a system that requires human-in-the-loop performance evaluation through MRMC studies. Therefore, I cannot extract the requested information regarding acceptance criteria, AI/human performance improvement, ground truth establishment for a test or training set, or expert qualifications and adjudication methods as these concepts are not applicable to the described device and its testing in the provided document.
To answer your question, information about AI-specific acceptance criteria, test set sizes, expert ground truth establishment, MRMC studies, and training set details would need to be present, which it is not in this document.
§ 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.