(63 days)
CaP3 Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CaP3 Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.
CaPy™ Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in bone void filler applications in the spine, pelvis, and extremities. At the time of use, the CaP3™ product material is combined with the mixing liguid (U.S.P. Sodium Chloride, 0.9%), and is mixed to form a paste. The paste can be administered to the treatment site by manual application, and be shaped in situ or into a desired form prior to implantation. After applying the paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP3™ Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
This appears to be a 510(k) summary for a bone substitute material, not a medical device driven by AI/ML or software. The provided text describes a synthetic bone graft material for filling bone voids. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training sets) are not applicable to this product.
Instead, the "acceptance criteria" and "study" for this type of medical device would typically refer to:
- Biocompatibility testing: Ensuring the material is not toxic and does not cause adverse biological reactions.
- Mechanical properties testing: Evaluating its strength, setting time, and other physical characteristics.
- Resorption rate studies: Demonstrating how it degrades and is replaced by natural bone over time.
- Osteoconductivity studies: Showing its ability to support bone growth.
- Sterility testing: Ensuring the product is free from microorganisms.
- Clinical or animal studies (if applicable for its classification/risk profile): Demonstrating safety and effectiveness in vivo.
- Substantial equivalence comparison: The primary "study" presented here is a comparison to a predicate device (α-BSM® Bone Substitute Material (K011048)) to establish substantial equivalence based on intended use, material properties, and performance characteristics.
The provided document states:
- Basis of Substantial Equivalence: "CaP3™ Bone Substitute Material is a synthetic bone graft substitute material substantially equivalent to a-BSM® Bone Substitute Materials... CaP3™ Bone Substitute Material is also similar to a-BSM® Bone Substitute Material in material properties and in product performance characteristics. Differences between the CaP3™ and a-BSM® products do not raise any new questions of safety and effectiveness."
This indicates that the "study" demonstrating it meets acceptance criteria is primarily a comparison of its properties and intended use to the predicate device, showing no new safety or effectiveness concerns. This is the standard pathway for 510(k) clearance for many non-software/AI devices.
Therefore, a table of "acceptance criteria" and "device performance" in the context of AI/ML metrics cannot be provided from this document. The "device performance" here relates to its physical, chemical, and biological properties being "similar" to the predicate, and not introducing new safety/effectiveness questions.
§ 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.